Product Code: FYA
FDA class 2
21 CFR 878.4040
Gown, Surgical
General, Plastic Surgery
A surgical gown is a sterile garment worn by members of the surgical team to establish a bacterial barrier between the patient and non-sterile areas of the operative environment, reducing infection risk. It is classified as FDA Class 2 (moderate risk), subject to general and special controls, and requires 510(k) premarket notification. The product code is FYA, regulated under 21 CFR 878.4040, within the General, Plastic Surgery medical specialty. No special flags apply to this device.
510(k)s
295
FEI Numbers
222
Registration Numbers
222
Unique Applicants
175
Years Active
50
Research product code FYA in seconds
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Basic Information
- Product Code
- FYA
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 295 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252575 | Tuff Cuff Disposable Surgical Gowns AAMI L4 Sterile-Large (ML-L4-STL-DC-L) | Jun 04, 2026 | Substantially Equivalent | New York Embroidery Studio (NYES) |
| K260725 | BAÜMER Surgical Gowns (COP01, COP04, COP05, COP10) | May 12, 2026 | Substantially Equivalent | Hindernis DE Mexico, S.A.P.I. DE C.V. |
| K253243 | Cardinal Health Poly Reinforced Surgical Gown | Apr 28, 2026 | Substantially Equivalent | Cardinal Health 200, LLC |
| K253003 | Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) | Apr 20, 2026 | Substantially Equivalent | Hubei Xinxin Non-Woven Co., Ltd. |
| K251860 | Copioumed AAMI 3 Surgical Gown | Feb 26, 2026 | Substantially Equivalent | Copioumed International, Inc. |
| K252301 | Henan Yadu Level 4 Surgical Gowns (Reinforced) | Feb 04, 2026 | Substantially Equivalent | Yadu Medical (Henan) Co., Ltd. |
| K250564 | Surgical Gown (Level 3: S, M, L, XL, XXL, XXXL) | Dec 03, 2025 | Substantially Equivalent | Yadu Medical (Henan) Co., Ltd. |
| K243522 | ViVi® Toga Premium | May 30, 2025 | Substantially Equivalent | Thi Total Healthcare Innovation GmbH |
| K242937 | Dream Medi Sterile Surgical Gown (SurgicalGownUL) | May 05, 2025 | Substantially Equivalent | Dae Myung Chemical Co., Ltd. (Vietnam) |
| K242844 | Medline Level 4 Surgical Gown with Breathable Sleeves | Feb 26, 2025 | Substantially Equivalent | Medline Industries, LP |
| K241272 | Stryker Steri-Shield 8 Surgical Hoods and Togas | Oct 16, 2024 | Substantially Equivalent | Stryker Instruments |
| K241214 | ProPel SG3 Surgical Gown | Sep 10, 2024 | Substantially Equivalent | Standard Textile Co., Inc. |
| K233571 | GCI Surgical Gown | Aug 02, 2024 | Substantially Equivalent | George Courey, Inc. |
| K233068 | Disposable Surgical Gown | Mar 29, 2024 | Substantially Equivalent | Nanning Tecbod Biological Technology Co., Ltd. |
| K233183 | Surgical Gown (40083) | Feb 01, 2024 | Substantially Equivalent | Ammex-Weida (Hubei) Health and Safety Products Co., Ltd. |
| K230707 | Skypro, Surgical Gown 6021 | Oct 12, 2023 | Substantially Equivalent | Skypro Medical Supplies Company |
| K230610 | Disposable Surgical Gown (Level 3, MF2103 Series), Disposable Surgical Gown (Level 3, MF2104 Series), Disposable Surgical Gown (Level 4, MF2105 Series) | Aug 23, 2023 | Substantially Equivalent | Dongguan Shin YI Healthcare Products Factory |
| K231510 | Surgical Gown (S,M,L,XL,XXL,XXXL); Reinforced Surgical Gown (S,M,L,XL,XXL,XXXL) | Aug 22, 2023 | Substantially Equivalent | Xiantao Zhibo Non-Woven Products Co., Ltd. |
| K230577 | Sterile Triplex Surgical Gown (S, M, L, XL, XXL, XXXL) | Aug 16, 2023 | Substantially Equivalent | Medcare Saglik Urunleri Sanayi VE Ticaret Anonim Sirketi |
| K230838 | Cardinal Health SmartGown EDGE Breathable Surgical Gown with ASSIST Instrument Pockets | Jul 27, 2023 | Substantially Equivalent | Cardinal Health200, LLC |
| K222999 | Surgical Gown | Jun 16, 2023 | Substantially Equivalent | Hubei Woozon Healthcare Co., Ltd. |
| K222456 | High Protection Surgical Gown | Mar 12, 2023 | Substantially Equivalent | 3A Medical Products Co., Ltd. |
| K223401 | Disposable Surgical Gowns (S,M,L,XL,XXL,XXXL) | Mar 07, 2023 | Substantially Equivalent | Xiamen Probtain Medical Techology Co., Ltd. |
| K221559 | Disposable Surgical Gown, Level 4; Disposable Surgical Gown, Level 3 | Feb 23, 2023 | Substantially Equivalent | Stringking |
| K213844 | Surgical Gown | Feb 16, 2023 | Substantially Equivalent | Bayteks Teknik Tekstil San. VE Tic. A.S. |
| K220435 | SEJONG Surgical Gown Soft | Feb 10, 2023 | Substantially Equivalent | Sejong Healthcare Co., Ltd. |
| K222403 | Surgical Gown | Jan 26, 2023 | Substantially Equivalent | Guangzhou Fuzelong Hygiene Material Co., Ltd. |
| K213893 | Comfort Gown, Safewear Gown | Dec 21, 2022 | Substantially Equivalent | Xuchang Zhengde Environstar Medical Products Co., Ltd. |
| K212812 | Surgical Gown | Nov 16, 2022 | Substantially Equivalent | Xianning Marveldas Protective Articles Co., Ltd. |
| K222480 | Standard Surgical Gown (AAMI Level 2); Reinforced Surgical Gown (AAMI Level 2) | Nov 14, 2022 | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. |
| K221139 | Bodygard SFS Surgical Gown Level 4 | Nov 10, 2022 | Substantially Equivalent | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri |
| K211060 | Disposable Surgical Gown Rk-3011C | Oct 28, 2022 | Substantially Equivalent | Xiantao Rhycom Non-Woven Products Co., Ltd. |
| K221977 | Disposable Surgical Gown (G4003) | Oct 20, 2022 | Substantially Equivalent | Xiantao Topmed Nonwoven Protective Products Co., Ltd. |
| K220092 | YADU Surgical Gowns | Oct 07, 2022 | Substantially Equivalent | Henan Yadu Industrial Co., Ltd. |
| K221637 | Surgical Gown (Sterile); Surgical Gown (Non-sterile) | Sep 29, 2022 | Substantially Equivalent | Allmed Medical (Hubei) Protective Products Co., Ltd. |
| K221717 | Disposable Surgical Gown UM-148 | Sep 20, 2022 | Substantially Equivalent | Unimax Medical Products Co., Ltd. |
| K221819 | 35g Standard SMMS Surgical Gown; 35g Reinforced SMMS Surgical Gown;43g Standard SMMS Surgical Gown;43g Reinforced SMMS Surgical Gown ;50g Standard SMMS Surgical Gown; 50g Reinforced SMMS Surgical Gown;BVB Surgical Gown | Sep 19, 2022 | Substantially Equivalent | Winner Medical Co., Ltd. |
| K211399 | Sterile Level 3 Surgical Gown | Jul 22, 2022 | Substantially Equivalent | Barco Tekstil Sanayi VE Ticaret A.S. |
| K220665 | Surgical Gown, Blue, Sterile; Surgical Gown, Blue, Non-Sterile | Jun 03, 2022 | Substantially Equivalent | Excellent Medical Technology Group Co., Ltd. |
| K220333 | Medline Orbis LVL 3 Surgical Gown | May 18, 2022 | Substantially Equivalent | Medline Industries, LP |
| K213177 | Plus Medical Cover Gown | May 11, 2022 | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. |
| K214108 | Medline Orbis Chemo Surgical Gown | May 06, 2022 | Substantially Equivalent | Medline Industries, LP |
| K211036 | Plus Medical Chemotherapy Gown | May 04, 2022 | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. |
| K214088 | Disposable Surgical Gown | Apr 12, 2022 | Substantially Equivalent | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
| K203237 | Dukal Sterile AAMI Level 3 Reinforced Surgical Gown, Sterile AAMI Level 3 Surgical Gown, Sterile AAMI Level 4 Surgical Gown, and Sterile AAMI Level 4 Splicing Surgical Gown | Mar 18, 2022 | Substantially Equivalent | Dukal Corporation |
| K201351 | Maxima Surgical Gown | Mar 11, 2022 | Substantially Equivalent | Elevate Textiles |
| K213703 | Surgical Gown | Mar 04, 2022 | Substantially Equivalent | Wujiang Tutaike Textiles & Finishing Co., Ltd. |
| K202845 | Bodygard SFS Surgical Gown Level 3 | Feb 24, 2022 | Substantially Equivalent | Feliks Plastik Laminasyon VE Ambalaj Malzemeleri Sanayi |
| K203548 | EndoArmor + Surgical Gown | Feb 21, 2022 | Substantially Equivalent | Boston Scientific Corporation |
| K212718 | Surgical gowns | Jan 12, 2022 | Substantially Equivalent | Xiantao Dingcheng Non-Woven Product Co., Ltd. |
| K212591 | Disposable Surgical Gown | Jan 11, 2022 | Substantially Equivalent | Suzhou Janee Medical Technology Co., Ltd. |
| K210355 | Surgical Gown, Model: surgical gown-hp-3 | Dec 16, 2021 | Substantially Equivalent | Weihai Dishang Medical Technology Co., Ltd. |
| K212861 | Surgical Gown, Reinforced Surgical Gown | Dec 15, 2021 | Substantially Equivalent | Wuhan Zonsen Medical Products Co., Ltd. |
| K212925 | Disposable Surgical Gown | Dec 13, 2021 | Substantially Equivalent | Henan Robestain Medical Products Co., Ltd. |
| K212869 | Disposable Surgical Gown, Disposable Reinforced Surgical Gown | Dec 13, 2021 | Substantially Equivalent | Fugou County Shenxiang Manufacturing Co., Ltd. |
| K203539 | Unico Global level 3 Surgical Gown (Film-reinforced SMS), Unico Global Level 3 Surgical Gown (PP+PE) | Dec 10, 2021 | Substantially Equivalent | Unicoglobal, Inc. |
| K211765 | Cardinal Health RoyalSilk Surgical Gown, Cardinal Health RoyalSilk Scrub Nurse Gown | Nov 23, 2021 | Substantially Equivalent | Cardinal Health, LLC |
| K211509 | Surgical Gown | Oct 24, 2021 | Substantially Equivalent | Hubei Wanli Protective Products Co., Ltd. |
| K211809 | Surgical Gown | Oct 18, 2021 | Substantially Equivalent | Wuhan Dymex Healthcare Co., Ltd. |
| K211077 | Surgical Gown | Oct 07, 2021 | Substantially Equivalent | Wujiang Tutaike Textiles & Finishing Co., Ltd. |
| K202532 | Disposable Surgical Gowns | Aug 21, 2021 | Substantially Equivalent | Anhui Medpurest Medical Technology Co.,Ltd |
| K210510 | Disposable Surgical Gown | Aug 12, 2021 | Substantially Equivalent | Shandong Zhushi Pharmaceutical Group Co., Ltd. |
| K210143 | Standard Surgical Gown (AAMI Level 3), Reinforced Surgical Gown (AAMI Level 3) | Jul 22, 2021 | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. |
| K210688 | AERO CHROME* Select Breathable Performance Surgical Gown, AERO CHROME* A-Line Breathable Performance Surgical Gown | Jul 21, 2021 | Substantially Equivalent | O&M Halyard, Inc. |
| K210215 | Surgical Gowns | Jul 07, 2021 | Substantially Equivalent | Jiangsu Province Jianerkang Medical Dressing Co., Ltd. |
| K211422 | Level 2 Standard Surgical Gown, Level 3 Standard Surgical Gown, Level 3 Reinforced Surgical Gown | Jul 02, 2021 | Substantially Equivalent | Jiangsu Medplus Non-Woven Manufacturer Co., Ltd. |
| K202447 | Medline Orbis Surgical Gown | Apr 02, 2021 | Substantially Equivalent | Medline Industries, Inc. |
| K202844 | Medical Surgical Gowns | Jan 06, 2021 | Substantially Equivalent | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. |
| K202706 | Surgical Gown (Sterile), Surgical Gown (Non-sterile) | Dec 31, 2020 | Substantially Equivalent | B.J.ZH.F.PANTHER MEDICAL EQUIPMENT CO., Ltd. |
| K200977 | Modular Toga | Aug 05, 2020 | Substantially Equivalent | Operating Room Innovations, Inc. |
| K200824 | Cardinal Health SMARTGOWN Breathable Surgical Gown, Cardinal Health SMARTGOWN AIR Breathable Surgical Gown | Jul 29, 2020 | Substantially Equivalent | Cardinal Health200, LLC |
| K192560 | Surgical Gown | May 22, 2020 | Substantially Equivalent | Shandong Kangli Medical Equipment Technology Co., Ltd. |
| K192290 | 50g SMS Standard Surgical Gown, 45g SMS Surgical Gown with Reinforcement, 68g BVB Surgical Gown, 68g BVB Splicing Surgical Gown | Apr 30, 2020 | Substantially Equivalent | Xuchang Zhengde Environstar Medical Products Co., Ltd. |
| K193327 | Cardinal Health ChemoPlus Full Coverage Gown, Closed Back, Cardinal Health ChemoPlus Full Coverage Gown, Open Back, Cardinal Health ChemoPlus Full Coverage Sleeve | Mar 20, 2020 | Substantially Equivalent | Cardinal Health200, LLC |
| K200522 | AERO CHROME* Breathable Performance Surgical Gowns | Mar 16, 2020 | Substantially Equivalent | O&M Halyard, Inc. |
| K192362 | Aero Blue Performance Surgical Gowns | Dec 13, 2019 | Substantially Equivalent | O&M Halyard, Inc. |
| K192194 | TotalShield II Surgical Helmet System | Oct 15, 2019 | Substantially Equivalent | Zimmer Surgical, Inc. |
| K190950 | Medline Level 2 Surgical Gown (Eclipse Non-Reinforced), Medline Level 3 Surgical Gown (Eclipse Fabric Reinforced), Medline Level 3 Surgical Gown (Sirus Non-Reinforced), Medline Level 3 Surgical Gown (Sirus Fabric Reinforced), Medline Level 3 Surgical Gown (Aurora Non Reinforced & Aurora Fabric Reinforced) | Jul 04, 2019 | Substantially Equivalent | Medline Industries, Inc. |
| K182172 | Medline Level 4 Surgical Gown (Sirus), Medline Level 4 Surgical Gown (Eclipse), Medline Level 4 Surgical Gown (Aurora) | Apr 24, 2019 | Substantially Equivalent | Medline Industries, Inc. |
| K173847 | Disposable Ultra Reinforced Surgical Gown | Jan 16, 2019 | Substantially Equivalent | Xiantao Rayxin Medical Products Co., Ltd. |
| K172987 | Surgical gown (AE1001, AE2001, AE3001); Surgical Gown (AG1001, AG2001, AG3001) | Jul 13, 2018 | Substantially Equivalent | Gmax Industries, Inc. |
| K172954 | Medline Prevention CoolZone Gown | Jun 15, 2018 | Substantially Equivalent | Medline Industries, Inc. |
| K172445 | RoyalGuard Surgical Gown, i600, Breathable | Dec 08, 2017 | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. |
| K170762 | Cardinal Health Non-Reinforced Surgical Gown | Jun 09, 2017 | Substantially Equivalent | Cardinal Health200, LLC |
| K162930 | Aero Chrome* Select Breathable Performance Surgical Gowns | Apr 21, 2017 | Substantially Equivalent | Halyard Health, Inc. |
| K163191 | ComfortGuard Surgical Gown, i600, Film Reinforced | Feb 27, 2017 | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. |
| K162442 | ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 | Dec 12, 2016 | Substantially Equivalent | Gri Medical & Electrical Technology Co., Ltd. |
| K150598 | Blockade Surgical Gown | Apr 28, 2016 | Substantially Equivalent | Medline Industries, Inc. |
| K153255 | Aero Chrome* Breathable Performance Surgical Gown | Apr 13, 2016 | Substantially Equivalent | Halyard Health, Inc. |
| K133075 | Plus Surgical Gowns (EO Sterilized), PMGB-XXX | Jun 24, 2015 | Substantially Equivalent | Foshan Nanhai Plus Medical Co, Ltd. |
| K150151 | SmartGownTM surgical gown | May 21, 2015 | Substantially Equivalent | Cardinal Health 200, Inc. |
| K141467 | SURGICAL GOWN | Mar 05, 2015 | Substantially Equivalent | Xuchang Zhengde Environstar Medical Products Co.,L |
| K141606 | SURGICAL GOWN | Nov 17, 2014 | Substantially Equivalent | Cobes Industries Co., Ltd. |
| K142166 | TOTAL SHIELD SURGICAL;TOGA(REGULAR, LARGE,X-LARGE);HOOD; HELMET ADVANCED HELMET W/LED LIGHTING, TOTAL SHIELD ACCESSORIES | Aug 28, 2014 | Substantially Equivalent | Zimmer, Inc. |
| K141095 | STRYKER STERI-SHIELD FLYTE HYBRID TOGAS | Aug 26, 2014 | Substantially Equivalent | Stryker Corporation |
| K140539 | AERO BLUE PERFORMANCE SURGICAL GOWN | Jun 09, 2014 | Substantially Equivalent | Kimberly-Clark Corporation |
| K121664 | T4/T5 HYTREL TOGAS | Mar 10, 2014 | Substantially Equivalent | Stryker Corporation |
| K132386 | TOTALSHIELD SURGICAL HELMET SYSTEM | Dec 23, 2013 | Substantially Equivalent | Zimmer, Inc. |
| K112796 | SURGICAL GOWN (EO STERILIZED) | Sep 12, 2013 | Substantially Equivalent | Cobes Industries Co., Ltd. |
| K121998 | HM SURGICAL GOWN, NON REINFORCED HM SURGICAL GOWN, FABRIC REINFORCED HM SURGICAL GOWN, POLYERINFORCED | Dec 20, 2012 | Substantially Equivalent | Changzhou Holymed Products Co., Ltd. |
| K121152 | SURGICAL GOWN, SMS | Dec 12, 2012 | Substantially Equivalent | Jiangsu Guangda Medical Material, Co., Ltd. |
| K120192 | DISPOSABLE SURGICAL GOWNS | Oct 16, 2012 | Substantially Equivalent | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. |
| K120045 | EMM HIGH PERFORMANCE SURGICAL GOWN WITH AAMI LIQUID BARRIER LEVEL IV | Jun 12, 2012 | Substantially Equivalent | Exact Medical Manufacturing, Inc. |
| K111535 | EMM SURGICAL GOWN - SPUNLACE WITH PE LAYER | Aug 26, 2011 | Substantially Equivalent | Exact Medical Manufacturing, Inc. |
| K111067 | JIE+HONG MEDICAL SURGICAL GOWNS - STERILE, JIE+HONG MEDICAL SURGICAL GOWNS - NON STERILE | Aug 02, 2011 | Substantially Equivalent | Kunshan Jiehong Nonwoven Product Co., Ltd. |
| K110724 | SURGICAL PROCEDURE PACKS | Jun 23, 2011 | Substantially Equivalent | Omnia Spa |
| K101468 | 3M BASIC DISPOSABLE SURGICAL GOWN, 3M HP DISPOSABLE SURGICAL GOWN, 3M REINFORCED DISPOSABLE SURGICAL GOWN, 3M DISPOSABLE | Apr 14, 2011 | Substantially Equivalent | 3M Company Corp |
| K102692 | SMS GOWNS (REINFORCED AND REINFORCED WITH GUIDER), SPUNLACE GOWNS (REGULAR, REGULAR WITH GUIDER), SPUNLACE GOWNS (REINFO | Mar 11, 2011 | Substantially Equivalent | Hangzhou Jincheng Medical Supplier Manufacture Co. |
| K102971 | FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK | Feb 23, 2011 | Substantially Equivalent | Microtek Medical, Inc. |
| K093835 | BAM STANDARD SURGICAL GOWN, BAM REINFORCED SURGICAL GOWN, BAM ULTRA REINFORCED SURGICAL GOWN | Feb 04, 2011 | Substantially Equivalent | Bam Corp., Ltd. |
| K102652 | NON REINFORCED SURGICAL GOWNS, FILM REINFORCED SURGICAL GOWNS, FABRIC REINFORCED SURGICAL GOWNS | Feb 03, 2011 | Substantially Equivalent | Gri Medical & Electronic Technology Co., Ltd. |
| K103406 | MICROCOOL BREATHABLE HIGH PERFORMANCE SURGICAL GOWNS | Dec 23, 2010 | Substantially Equivalent | Kimberly-Clark Corp. |
| K100971 | ATEK SURGICAL GOWNS | Sep 27, 2010 | Substantially Equivalent | Hangzhou Atek Medical & Textile Co., Ltd. |
| K101593 | EMM SURGICAL GOWN-SMS WITH PE LAYER, MODEL 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL | Sep 03, 2010 | Substantially Equivalent | Exact Medical Manufacturing, Inc. |
| K093115 | KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 | Mar 19, 2010 | Substantially Equivalent | Kimberly-Clark Corp. |
| K092344 | LAC-MAC INNERBLOC LR SURGICAL GOWNS | Dec 17, 2009 | Substantially Equivalent | Lac Mac, Ltd. |
| K093169 | SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) | Nov 12, 2009 | Substantially Equivalent | A Plus International, Inc. |
| K091357 | MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 | Aug 10, 2009 | Substantially Equivalent | Kimberly-Clark Corp. |
| K090383 | SRI LEVEL II SURGICAL GOWN | May 29, 2009 | Substantially Equivalent | Sri Surgical |
| K091097 | PROMEDICAL SURGICAL GOWN, MODELS 18-301, 18-401 AND 18-501 | May 27, 2009 | Substantially Equivalent | Promedical Products Co., Ltd. |
| K082479 | SKLAR SURGICAL GOWN | Apr 24, 2009 | Substantially Equivalent | Sklar Corp. |
| K080723 | SRI LP GOWN | Nov 13, 2008 | Substantially Equivalent | Sri/Surgical Express, Inc. |
| K080707 | SRI PLR GOWN | Nov 13, 2008 | Substantially Equivalent | Sri/Surgical Express |
| K080795 | ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN | Sep 03, 2008 | Substantially Equivalent | Kimberly-Clark Corp. |
| K080627 | PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A | Apr 24, 2008 | Substantially Equivalent | Promedical Products Co., Ltd. |
| K073017 | STRYKER STRI-SHIELD FLYTE TOGAS | Nov 30, 2007 | Substantially Equivalent | Stryker Instruments, Instruments Div. |
| K070431 | WELMED, INC. SURGICAL GOWNS | May 24, 2007 | Substantially Equivalent | Welmed, Inc. |
| K063005 | STRYKER T6 HOODS AND TOGAS | Mar 23, 2007 | Substantially Equivalent | Stryker Instruments |
| K062479 | JOYKEY SURGICAL GOWNS (STERILE) | Mar 14, 2007 | Substantially Equivalent | Joykey Industryial , Ltd. |
| K070078 | STRYKER T4 HYTREL TOGA | Feb 02, 2007 | Substantially Equivalent | Stryker Instruments, Instruments Div. |
| K062899 | MICROTEK MEDICAL SURGICAL GOWN/TOGA | Jan 25, 2007 | Substantially Equivalent | Microtek Medical, Inc. |
| K062969 | MEDLINE STERILE DISPOSABLE SURGICAL GOWNS | Dec 14, 2006 | Substantially Equivalent | Medline Industries, Inc. |
| K061491 | LAC-MAC INNERBLOC O.R. GOWN | Aug 09, 2006 | Substantially Equivalent | Lac Mac, Ltd. |
| K061308 | TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N | Jun 05, 2006 | Substantially Equivalent | Cardinal Health 200, Inc. |
| K052824 | KIMBERLY-CLARK PROCEDURE GOWN | May 02, 2006 | Substantially Equivalent | Kimberly-Clark Corp. |
| K060181 | COMPE1 1 -PLY SURGICAL GOWNS | Mar 07, 2006 | Substantially Equivalent | Standard Textile Co., Inc. |
| K052550 | IMC SURGICAL GOWNS | Nov 17, 2005 | Substantially Equivalent | Intl. Medsurg Connection, Inc. |
| K051426 | CARLO SURGICAL GOWN | Aug 02, 2005 | Substantially Equivalent | Sofilm Technology Co., Ltd. |
| K041653 | COMPEL 1-PLY SURGICAL GOWNS; COMPEL ISOLATION GOWNS | Jul 01, 2005 | Substantially Equivalent | Standard Textile Co., Inc. |
| K050786 | BARRIER SURGICAL GOWNS | May 09, 2005 | Substantially Equivalent | Molnlycke Health Care |
| K041540 | COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS | May 05, 2005 | Substantially Equivalent | Standard Textile Co., Inc. |
| K041539 | COMPEL SURGICAL GOWNS | Apr 28, 2005 | Substantially Equivalent | Standard Textile Co., Inc. |
| K043004 | STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 | Mar 16, 2005 | Substantially Equivalent | Viasys Medsystems |
| K041541 | COMPEL MLR SURGICAL GOWNS | Mar 16, 2005 | Substantially Equivalent | Standard Textile Co., Inc. |
| K043585 | MEDLINE SURGICAL GOWNS | Mar 08, 2005 | Substantially Equivalent | Medline Industries, Inc. |
| K043017 | PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS | Mar 08, 2005 | Substantially Equivalent | Medline Industries, Inc. |
| K042111 | PROMEDICAL SURGICAL GOWNS | Dec 10, 2004 | Substantially Equivalent | Promedical Products Co., Ltd. |
| K040485 | MAXAIR SURGICAL HELMET SYSTEM | Oct 18, 2004 | Substantially Equivalent | Bio-Medical Devices, Inc. |
| K040764 | STRYKER T4 HYTREL ZIPPER TOGA | Apr 27, 2004 | Substantially Equivalent | Stryker Corp. |
| K032631 | INNERBLOC LR SURGICAL GOWNS BASED ON GORE LR FABRIC (REUSABLE 100X) | Feb 05, 2004 | Substantially Equivalent | Lac Mac, Ltd. |
| K033057 | DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE | Nov 20, 2003 | Substantially Equivalent | Deroyal |
| K031408 | DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) | Oct 15, 2003 | Substantially Equivalent | Deroyal |
| K031933 | MEDLINE REUSABLE SURGICAL GOWNS (100X) | Sep 16, 2003 | Substantially Equivalent | Medline Industries, Inc. |
| K030536 | LAC-MAC LIMITED INNERBLOC O.R. GOWN | May 06, 2003 | Substantially Equivalent | Lac Mac, Ltd. |
| K030364 | DEROYAL GOWNS, STERILE, NON-STERILE | Apr 28, 2003 | Substantially Equivalent | Deroyal Industries, Inc. |
| K021992 | DHS DISPOSABLE HOOD SYSTEM | Jan 14, 2003 | Substantially Equivalent | Biomet, Inc. |
| K023635 | SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN | Nov 18, 2002 | Substantially Equivalent | Sri/Surgical Express, Inc. |
| K023266 | PRIMAGARD SURGICAL GOWNS | Nov 08, 2002 | Substantially Equivalent | Primeline Medical Products, Inc. |
| K023167 | BREATHABLE SURGICAL GOWN | Oct 02, 2002 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K022162 | STRYKER T4 URETHANE HOOD; STRYKER T4 URETHANE ZIPPER TOGA; STRYKER T4 URETHANE PULLOVER TOGA | Aug 01, 2002 | Substantially Equivalent | Stryker Instruments |
| K013846 | ULTRAGARD IMPERVIOUS REINFORCED GOWN | May 22, 2002 | Substantially Equivalent | Precept Medical Products, Inc. |
| K020593 | CONVERTORS SMS POLYOLEFIN GOWN | Mar 18, 2002 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K012186 | MASTER & FRANK SURGICAL GOWNS (STERILE) | Dec 07, 2001 | Substantially Equivalent | Master & Frank Ent. Co., Ltd. |
| K012268 | TRIMAX | Dec 03, 2001 | Substantially Equivalent | Standard Textile Co., Inc. |
| K012240 | MERTEX-PLUS O.R./SURGEONS GOWN, NONSTERILE | Oct 15, 2001 | Substantially Equivalent | Mercan AB |
| K012984 | BREATHABLE IMPERVIOUS GOWNS | Sep 24, 2001 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K010799 | COMBOSAFE SURGICAL GOWNS, NON-STERILE (75X REUSABLE) | Jun 07, 2001 | Substantially Equivalent | Standard Textile Co., Inc. |
| K003755 | MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES | Feb 16, 2001 | Substantially Equivalent | Medline Industries, Inc. |
| K003194 | STACKHOUSE LENS HOOD, MODEL SA-700/FS | Oct 26, 2000 | Substantially Equivalent | Stackhouse, Inc. |
| K000605 | STACKHOUSE LENS HOOD, MODEL SA-700/F | Aug 17, 2000 | Substantially Equivalent | Stackhouse, Inc. |
| K000902 | KLINIDRAPE REINFORCED SURGICAL GOWNS | Jul 11, 2000 | Substantially Equivalent | Molnlycke Health Care, Inc. |
| K000901 | KLINIDRAPE SURGICAL GOWNS, NON-REINFORCED, BASIC PROTECTIONS AND STANDARD PROTECTION | Jul 05, 2000 | Substantially Equivalent | Molnlycke Health Care, Inc. |
| K001189 | MODIFICATION TO CONVERTORS SURGICAL GOWNS | Apr 21, 2000 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K993170 | MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS | Mar 02, 2000 | Substantially Equivalent | Medline Industries, Inc. |
| K994244 | CONVERTORS SURGICAL GOWNS, STERILE | Feb 18, 2000 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K992445 | MED-GUARD SURGEON'S GOWN | Feb 18, 2000 | Substantially Equivalent | Kappler USA |
| K992436 | GOWN BACK, MODEL 13-403N; 13-404N; 13-405N | Jan 20, 2000 | Substantially Equivalent | Techstyles |
| K994053 | STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE | Dec 20, 1999 | Substantially Equivalent | Stryker Instruments |
| K993148 | STRYKER T4 HOOD, STRYKER T4 ZIPPERED TOGA, STRYKER T4 PULLOVER TOGA | Oct 15, 1999 | Substantially Equivalent | Stryker Instruments |
| K992951 | CONVERTORS SURGICAL GOWNS | Sep 22, 1999 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K992514 | CONVERTORS BREATHABLE SURGICAL GOWNS | Aug 12, 1999 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K991034 | CONVERTORS SURGICAL GOWNS | Apr 16, 1999 | Substantially Equivalent | Allegiance Healthcare Corp. |
| K990395 | BARRIER SURGICAL GOWNS | Apr 13, 1999 | Substantially Equivalent | Johnson & Johnson Medical, Div. of Ethicon, Inc. |
| K984422 | STERILE BACK SURGICAL GOWN WITH HAND TOWEL | Apr 02, 1999 | Substantially Equivalent | Medical Sterilization, Inc. |
| K982058 | ROTECNO FR (FLUID RESISTANT) SURGICAL GOWN | Jan 14, 1999 | Substantially Equivalent | Encompass Group, LLC |
| K982694 | MEDLINE MEDCREST SURGICAL GOWNS AND SURGICAL DRAPES | Dec 14, 1998 | Substantially Equivalent | Medline Industries, Inc. |
| K982059 | ROTECNO 2000 SURGICAL GOWN | Nov 30, 1998 | Substantially Equivalent | Encompass Group, LLC |
| K982693 | MEDINE DISPOSABLE STERILE ZONED IMPERVIOUS SURGICAL GOWNS | Oct 28, 1998 | Substantially Equivalent | Medline Industries, Inc. |
| K981393 | MICROCOOL SURGICAL GOWN | Jul 10, 1998 | Substantially Equivalent | Kimberly-Clark Corp. |
| K981073 | MEDCOM GOWN PACK, MEDCOM DRAPE PACK & MEDCOM TOWEL PACK | May 15, 1998 | Substantially Equivalent | Medcom Laundry Service, Inc. |
| K971920 | GOWN POLY REINFORCED LARGE(PRODUCT NO.900-522)/(REORDER NO. 0522) | Dec 04, 1997 | Substantially Equivalent | Customed, Inc. |
| K972832 | PROVISION SURGICAL HELMET SYSTEM | Oct 21, 1997 | Substantially Equivalent | Depuy, Inc. |
| K970893 | ULTRASOUND TRANSDUCER DRAPE | Oct 20, 1997 | Substantially Equivalent | Protek Medical Products, Inc. |
| K962666 | BEMISS JASON-STERILE,NON-STERILE,REINFORCED STERILE,AND REINFORCED NON-STERILE SURGICAL GOWN | Feb 27, 1997 | Substantially Equivalent | Bemiss-Jason Corp., Triad Medical Div. |
| K954674 | P1OP2B OR P1O92T | Jan 30, 1997 | Substantially Equivalent | Kay Borch A/S |
| K963809 | COOL-ZONE | Nov 20, 1996 | Substantially Equivalent | Kappler USA |
| K961341 | CONVERTORS POLYOLEFIN FABRIC GOWNS | Oct 28, 1996 | Substantially Equivalent | Baxter Healthcare Corp |
| K961239 | DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL | Sep 17, 1996 | Substantially Equivalent | Depuy, Inc. |
| K955586 | ROBISON & SMITH SURGICAL PACKS | Aug 30, 1996 | Substantially Equivalent | Robison & Smith, Inc. |
| K961083 | OREX SURGEON'S VEST | Aug 23, 1996 | Substantially Equivalent | Thantex Specialties, Inc. |
| K960073 | EZ-PERSONAL PROTECTION KIT WITH SPILL CLEAN UP | Jul 12, 1996 | Substantially Equivalent | Safetec of America, Inc. |
| K953251 | MERTEX-PLUS O.R./SURGEONS GOWN | Sep 05, 1995 | Substantially Equivalent | Mercana Industries , Ltd. |
| K944393 | STRYKER STERI-SHIELD SURGICAL APPAREL | Aug 28, 1995 | Substantially Equivalent | Stryker Corp. |
| K951623 | TLC SURGICAL GOWNS | Aug 18, 1995 | Substantially Equivalent | Tlc Tech Lab Clothes, Inc. |
| K951984 | WHITE KNIGHT SURGEON'S VEST | Jul 25, 1995 | Substantially Equivalent | White Knight Healthcare |
| K945371 | COMPEL 3000 SURGICAL GOWN, COMPEL 2G SURGICAL GOWNS | Apr 27, 1995 | Substantially Equivalent | Standard Textile Co., Inc. |
| K950504 | PERVAL SURGICAL GOWN (MARKETING NAME) | Apr 25, 1995 | Substantially Equivalent | Standard Textile Co., Inc. |
| K945658 | INTERWOVEN(TM) REUSABLE SURGICAL GOWN | Mar 22, 1995 | Substantially Equivalent | Baxter Healthcare Corp |
| K944827 | OREX SURGEON'S GOWN | Feb 28, 1995 | Substantially Equivalent | Thantex Specialties, Inc. |
| K944138 | INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL | Dec 20, 1994 | Substantially Equivalent | Baxter Healthcare Corp |
| K931562 | GUARDIAN SURGEON'S GOWNS | Oct 07, 1994 | Substantially Equivalent | Atkins Healthcare Services |
| K940931 | ASEP(TM) PLUS SURGICAL GOWN | Jul 26, 1994 | Substantially Equivalent | Angelica Uniform Group, Inc. |
| K931456 | SURGICAL DRAPE AND GOWN TRAY | Jul 08, 1994 | Substantially Equivalent | Custom Medical Products, Ltd. |
| K931144 | STERILE SURGEON'S GOWN, MODIFICATION | Jun 10, 1994 | Substantially Equivalent | Amsco Sterile Recoveries, Inc. |
| K934664 | HYDRAGOWN | May 24, 1994 | Substantially Equivalent | Mallinckrodt Group, Inc. |
| K940758 | COMPEL SURGICAL GOWNS | Apr 22, 1994 | Substantially Equivalent | Standard Textile Co., Inc. |
| K934608 | BARRIER FABRIC 450 SURGICAL GOWN | Apr 11, 1994 | Substantially Equivalent | Johnson & Johnson Medical, Inc. |
| K932694 | KAPPLER PRO/VENT PROCEDURE GOWN | Mar 29, 1994 | Substantially Equivalent | Kappler, Inc. |
| K940069 | DRESSING CHANGE KIT | Mar 18, 1994 | Unknown | Mason-Keller Corp. |
| K935660 | MEDICOTEX(TRADEMARK APPLICATION PENDING) | Mar 07, 1994 | Substantially Equivalent | Itochu International, Inc. |
| K930681 | 3M PREVENTION FABRIC SURGICAL GOWN #78XX | Feb 10, 1994 | Substantially Equivalent | 3M Health Care, Ltd. |
| K924055 | N-PAC | Aug 27, 1993 | Unknown | National Healthcare Linen Service |
| K926519 | SURGICAL GOWN | Aug 12, 1993 | Substantially Equivalent | Custom Medical Products, Ltd. |
| K921158 | O.R./SURGEONS GOWN, ITEM NO. 4950 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921157 | O.R./SURGEONS GOWN, ITEM NO. 4942 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921156 | O.R./SURGEONS GOWN, ITEM NO.4941 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921155 | O.R./SURGEONS GOWN, ITEM NO. 4962 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921154 | O.R./SURGEONS GOWN, ITEM NO. 4962 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921153 | O.R./SURGEONS GOWN, ITEM NO. 4960 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921152 | O.R./SURGEONS GOWN, ITEM NO. 4952 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K921151 | O.R./SURGEONS GOWN, ITEM NO. 4951 | Jul 09, 1993 | Substantially Equivalent | The Sewing Source, Inc. |
| K932003 | N-PAC STYLE C (D-STAT O.R. PROTECTIVE GOWN) | Jun 11, 1993 | Substantially Equivalent | National Healthcare Linen Service |
| K925715 | RS OPTIGUARD GOWN & DRAPE MATERIAL | May 11, 1993 | Substantially Equivalent | Baxter Healthcare Corp |
| K923815 | TOTAL PROTECTIVE BREATHEABLE SURGICAL GOWNS | Mar 31, 1993 | Substantially Equivalent | Laivan Corp. |
| K922753 | COMPEL XTR | Mar 09, 1993 | Substantially Equivalent | Standard Textile Co., Inc. |
| K921889 | COMPEL O AND R | Feb 18, 1993 | Substantially Equivalent | Standard Textile Co., Inc. |
| K922949 | SURGICAL GOWN | Feb 16, 1993 | Substantially Equivalent | Robert J. Sislian, Inc. |
| K920568 | STERILE DISPOSABLE SURGICAL GOWN W/ TOWEL | Oct 22, 1992 | Substantially Equivalent | Border Opportunity Saver Systems, Inc. |
| K920405 | STERILE SURGEON'S GOWN | Aug 18, 1992 | Substantially Equivalent | Amsco Sterile Recoveries, Inc. |
| K920996 | BARRIER SURGICAL GOWN WITH SYMETRY FABRIC | May 31, 1992 | Substantially Equivalent | Johnson & Johnson Medical, Inc. |
| K920837 | STERILE CONVERTOR SAFECARE GOWN AND DRAPE | May 22, 1992 | Substantially Equivalent | Baxter Healthcare Corp |
| K915502 | MEDLINE, GORE-TEX BARRIER, SURGICAL GOWNS & DRAPES | Apr 29, 1992 | Substantially Equivalent | Medline |
| K914235 | ASEP SURGEONS GOWN | Apr 14, 1992 | Substantially Equivalent | Baxter Interwoven Offsite |
| K914839 | COMPEL E | Apr 02, 1992 | Substantially Equivalent | Standard Textile Co., Inc. |
| K914563 | STERILE SUGICAL GOWN PACK | Jan 10, 1992 | Unknown | Assured Surgical Products, Inc. |
| K912803 | MSI STERILE BACK SURGICAL GOWN PACK HAND TOWEL | Jan 10, 1992 | Substantially Equivalent | Medical Sterilization, Inc. |
| K911508 | MAGNA SURGEONS GOWNS | Jun 17, 1991 | Substantially Equivalent | Dms Miami, Inc. |
| K910515 | FREEDOM MARK III SURGICAL HELMET SYSTEM | May 06, 1991 | Substantially Equivalent | Stackhouse Assoc. |
| K911568 | GOWN, OPERATING SURGICAL | Apr 22, 1991 | Substantially Equivalent | Huntsville Rehabilitation Foundation |
| K901536 | STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV | Nov 29, 1990 | Substantially Equivalent | Depuy, Inc. |
| K902348 | SURGICAL GOWN, POLYULTRA(TM) FABRIC SYSTEM* | Sep 06, 1990 | Substantially Equivalent | Futuristic Medical Concepts, Inc. |
| K896935 | CONVERTORS BREATHABLE GOWN MATERIAL PRODUCT LINE | Feb 16, 1990 | Substantially Equivalent | Baxter Healthcare Corp |
| K894599 | SHIRT, OPERATING, SURGICAL | Aug 11, 1989 | Substantially Equivalent | Miroz Industries Co. |
| K894284 | GOWN, OPERATING, SURGICAL | Jul 14, 1989 | Substantially Equivalent | Miroz Industries Co. |
| K892118 | NON-STERILE MASKS AND CAPS | Apr 20, 1989 | Substantially Equivalent | Paramount Products, Inc. |
| K891211 | SURGICAL GOWN #2001 | Apr 14, 1989 | Substantially Equivalent | Pro-Safe Professional Linens, Inc. |
| K891058 | DENTAL GOWN | Apr 12, 1989 | Substantially Equivalent | Dispomed, Inc. |
| K890474 | SURGICAL GOWNS | Feb 23, 1989 | Substantially Equivalent | Victoria Slipper Retail & Mfg., Co. |
| K883464 | SURGICAL SHIRT | Aug 26, 1988 | Substantially Equivalent | Arkansas Lighthouse For the Blind |
| K882470 | STERILE DISPOSABLE SURGICAL GOWNS | Aug 03, 1988 | Substantially Equivalent | Bolden Products, Div. of the Transport Group |
| K880386 | KIMBERLY-CLARK PROTECTIVE SLEEVE | Jun 23, 1988 | Substantially Equivalent | Kimberly-Clark Corp. |
| K880383 | KIMBERLY-CLARK FULL LENGTH HEAVY DUTY APRON | Jun 23, 1988 | Substantially Equivalent | Kimberly-Clark Corp. |
| K880382 | KIMBERLY-CLARK IMPERVIOUS OPEN BACK GOWN | Jun 23, 1988 | Substantially Equivalent | Kimberly-Clark Corp. |
| K872758 | THEATRE GOWNS | Jul 31, 1987 | Substantially Equivalent | Smith & Nephew, Inc. |
| K871906 | UNIMED SURGEON'S GOWNS | Jun 09, 1987 | Substantially Equivalent | Unimed Hospital Supply Corp. |
| K864311 | STERILE BACK GOWN/STAND BACK GOWN(VARIOUS SIZES) | Nov 26, 1986 | Substantially Equivalent | Clinitech, Inc. |
| K861600 | SPUNGUARD PLUS SURGICAL GOWN | May 12, 1986 | Substantially Equivalent | Kimberly-Clark Corp. |
| K852870 | BARRIER SURGICAL GOWN | Jul 23, 1985 | Substantially Equivalent | Surgikos, Inc. |
| K851938 | OMNIMED SURGICAL GOWN | Jun 28, 1985 | Substantially Equivalent | Omni Intl., Inc. |
| K851559 | TURQUOISE | Apr 30, 1985 | Substantially Equivalent | Roseburg SA |
| K850177 | MATRIX DRI-IDEA (PLASTIC DISPOS. SURGICAL GOWN) | Feb 21, 1985 | Substantially Equivalent | Matrix Medica, Inc. |
| K844703 | GOWNS, SURGICAL | Jan 10, 1985 | Substantially Equivalent | Medicon, Inc. |
| K842958 | BOUNDARY SINGLE-USE OR GOWN | Aug 17, 1984 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
| K834332 | BOUNDARY SINGLE-USE GOWNS | May 01, 1984 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
| K822925 | BOUNDARY SINGLE-USE GOWNS | Jan 12, 1983 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K821564 | BOUNDARY PROCESS CHANGE | Jul 02, 1982 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K820363 | DISPOSABLE SURGICAL GARMENTS | Mar 08, 1982 | Substantially Equivalent | Alphamedix, Inc. |
| K820116 | BOUNDARY | Feb 23, 1982 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K813390 | BONDARY SINGLE-USE OR GOWN | Jan 05, 1982 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K811958 | BOUNDARY REINFORCED OR GOWN | Jul 27, 1981 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K803158 | IRRADIATED BOUNDARY DEVICES | Jan 15, 1981 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K802885 | L.A.F. ISOLATION PACK | Jan 15, 1981 | Substantially Equivalent | Action Medical Systems, Inc. |
| K801025 | ODOR MASKING AGENT FOR CONTENTS OF ALL | May 30, 1980 | Substantially Equivalent | The Buckeye Cellulose Corp. |
| K800929 | WHITE KNIGHT SURGICAL PACK | May 20, 1980 | Substantially Equivalent | G.D. Searle and Co. |
| K800927 | WHITE KNIGHT DISP. STERILE BACK GOWN | May 20, 1980 | Substantially Equivalent | G.D. Searle and Co. |
| K800124 | ULTRASOFT GOWN | Feb 05, 1980 | Substantially Equivalent | Mars Mfg Co. |
| K792622 | STERILIZATION PROCESS /USE GOWNS | Jan 11, 1980 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
| K791062 | BOUNDARY SPECIALTY GOWN | Jun 20, 1979 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
| K781682 | SURGICAL GOWNS & DRAPES | Dec 20, 1978 | Substantially Equivalent | Kimberly-Clark Corp. |
| K781099 | SURGICAL GOWNS AND DRAPES | Aug 14, 1978 | Substantially Equivalent | Convertors |
| K772182 | SURGICAL GOWN, REINFORCED | Dec 08, 1977 | Substantially Equivalent | Surgikos, Inc. |
| K760554 | APPAREL, BARRIER SCRUB | Nov 12, 1976 | Substantially Equivalent | Surgikos, Inc. |
| K760903 | BARRIER FABRIC 450 SURGICAL GOWNS | Nov 11, 1976 | Substantially Equivalent | Surgikos, Inc. |
| K760864 | BARRIER FABRIC 450 SPECIALTY GOWN | Nov 03, 1976 | Substantially Equivalent | Surgikos, Inc. |
| K760237 | GOWN, BOUNDARY SINGLE USE REINFORCED | Aug 11, 1976 | Substantially Equivalent | Procter & Gamble Mfg. Co. |
FEI Numbers
This FDA classification entry is associated with 222 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 222 registration numbers. Click on an entry to view related FDA registrations.