Product Code: LYU
FDA class 1
21 CFR 878.4040
Accessory, Surgical Apparel
General, Plastic Surgery
The Surgical Apparel Accessory (product code LYU) is a supplementary item worn by surgical team members, such as additional covers, wraps, or protective components used in conjunction with standard surgical gowns and attire. Regulated under 21 CFR 878.4040 and classified as a Class 1 device subject only to general controls, it falls under the General and Plastic Surgery specialty with review by the General Hospital (HO) panel. It is not an implant, is not life-sustaining, and is not GMP-exempt.
510(k)s
56
FEI Numbers
877
Registration Numbers
878
Unique Applicants
43
Years Active
13
Basic Information
- Product Code
- LYU
- Device Class
- FDA class 1
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 4
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 56 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K011755 | STRYKER T4 HYTREL (R) TOGAS | Jun 22, 2001 | Substantially Equivalent | STRYKER CORP. |
| K965237 | NURSES BOUFFANT CAP | Aug 27, 1997 | Substantially Equivalent | COPIOUMED INTL., INC. |
| K970988 | FAR-EAST BOUFFANT CAPS | Jul 10, 1997 | Substantially Equivalent | FAR EAST SCIENCE & TECHNOLOGY DEVELOPMENT CO., LTD |
| K964364 | DISPOSABLE APRON | Feb 25, 1997 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K961791 | DEPUY DISPOSABLE FILTER/HOOD | Aug 09, 1996 | Substantially Equivalent | DEPUY, INC. |
| K961454 | AMMI MAGNI-GUARD | Jul 25, 1996 | Substantially Equivalent | AMERICAN MEDICAL MFG., INC. |
| K945302 | SLOAN STA-DRI PANT PROTECTOR | Mar 19, 1996 | Substantially Equivalent | SLOAN CORP. |
| K954314 | ULTRAFIT LINERS | Dec 28, 1995 | Substantially Equivalent | STAHMER WESTON SCIENTIFIC |
| K953089 | I-SPOUSE | Oct 16, 1995 | Substantially Equivalent | PRODUCTS FOR MEDICINE |
| K952303 | SPLASH ASSIST | Aug 24, 1995 | Substantially Equivalent | INNOVATIVE OUTSOURCING SOLUTIONS |
| K942200 | ISOLYSER OREX SURGEON'S CAPS, HOODS, BOUFFANT CAPS | Aug 07, 1995 | Substantially Equivalent | THANTEX SPECIALTIES, INC. |
| K944276 | SLOAN STA-DRI BOOTLEG LEGGING | Jul 31, 1995 | Substantially Equivalent | SLOAN CORP. |
| K944118 | SLOAN STA-DRI SURGICAL JUMPSUIT | Jul 31, 1995 | Substantially Equivalent | SLOAN CORP. |
| K946003 | INTEC FULL FACE SHIELD | Jun 28, 1995 | Substantially Equivalent | INTEC INDUSTRIES, INC. |
| K951420 | INCASE EXTENSIBLE BAG--NON-STERILE | Jun 08, 1995 | Substantially Equivalent | ALPHA SURGICAL, INC. |
| K944763 | CUT-TEC OR WELLS LAMONT POLYESTER/WIRE CUT-RESISTANT GLOVE LINER WELLS-TEC, SCEPTER | Apr 10, 1995 | Substantially Equivalent | WELLS LAMONT CORP. |
| K945098 | OP-D-OP II | Feb 28, 1995 | Substantially Equivalent | OP-D-OP VISOR SHIELDS, INC. |
| K942828 | MAKAR FULL AND HALF FACE SHIELD | Feb 23, 1995 | Substantially Equivalent | INSTRUMENT MAKAR, INC. |
| K943809 | MONOGARD FACE SHIELD | Nov 28, 1994 | Substantially Equivalent | WHITE KNIGHT HEALTHCARE |
| K940228 | BOUFFANT CAP | Sep 26, 1994 | Substantially Equivalent | DEREKDUCK INDUSTRIES CORP. |
| K940226 | SHOE COVER | Sep 26, 1994 | Substantially Equivalent | DEREKDUCK INDUSTRIES CORP. |
| K940723 | BODY BOOT | Sep 06, 1994 | Substantially Equivalent | MARK-CLARK |
| K941932 | SPLASH MASK | Jul 19, 1994 | Substantially Equivalent | INCON DIVERSIFIED INDUSTRIES, INC. |
| K942022 | FACE-IT SHIELD | Jul 08, 1994 | Substantially Equivalent | ONYX MEDICAL CORP. |
| K932953 | DERMAL GLOVES | Jun 24, 1994 | Substantially Equivalent | GEORGE GLOVE COMPANY, INC. |
| K940274 | NYLON LINER GLOVES | May 12, 1994 | Substantially Equivalent | WELLS LAMONT CORP. |
| K935158 | KACEY DISPOSABLE GLOVE LINER | Apr 20, 1994 | Substantially Equivalent | K & C MEDICAL, INC. |
| K931042 | MOORE SECURE CAP | Apr 13, 1994 | Substantially Equivalent | KERMA MEDICAL PRODUCTS, INC. |
| K935723 | SPLASHMASTER FACE PROTECTIVE PRODUCTS (TUFFSHIELD FACESHIELD, VISTACLEAR FACESHIELD) | Apr 06, 1994 | Substantially Equivalent | CABOT SAFETY CORP. |
| K934842 | TECNOL SPLASHGUARD | Mar 09, 1994 | Substantially Equivalent | TECNOL MEDICAL PRODUCTS, INC. |
| K931094 | PROCEL(TM) DERMALINER GLOVE | Feb 14, 1994 | Substantially Equivalent | W.L. GORE & ASSOCIATES,INC |
| K935779 | AGAFAR FACE SHIELD | Feb 01, 1994 | Substantially Equivalent | INFECTION CONTROL PRODUCTS, INC. |
| K931288 | ISOLAIR 2 FULL FACE SPLASH GUARD | Jan 21, 1994 | Substantially Equivalent | LOUIS M. GERSON CO., INC. |
| K926438 | ACTION MEDTEK FACE SHIELD | Aug 18, 1993 | Substantially Equivalent | ACTION EYEWEAR CORP. |
| K925290 | CATALOG NUMBER 111 (FACESHIELD) | Jul 23, 1993 | Substantially Equivalent | ANSLEY MEDICAL PRODUCTS, INC. |
| K925628 | ULTRATUFF CUT RESISTANT GLOVE LINER | Jul 09, 1993 | Substantially Equivalent | BAXTER HEALTHCARE CORP. |
| K922407 | WELLS LAMONT CUT RESISTANT SURGICAL GLOVE LINERS | Jun 15, 1993 | Substantially Equivalent | WELLS LAMONT CORP. |
| K923229 | MEDARMOR FINGER TIP, PUNCTURE RESISTANT UNDERGLOVE | May 07, 1993 | Substantially Equivalent | MEDICAL ARMOR CORP. |
| K915415 | GUARDALL SHIELD | Oct 15, 1992 | Substantially Equivalent | ANAGO, INC. |
| K915056 | FINGGUARD | Feb 03, 1992 | Substantially Equivalent | ALLIED SIGNAL, INC. |
| K914077 | REPEL(TM) LITE CUT RESISTANT GLOVE LINERS | Dec 02, 1991 | Substantially Equivalent | DEPUY-RAYNHAM |
| K912737 | MEDARMOR FINGERTIP, PUNC/CUT RESIST SURG EXAM GLOV | Oct 08, 1991 | Substantially Equivalent | MEDICAL ARMOR CORP. |
| K912457 | MEDARMOR FINGERTIP, PUNCTURE AND CUT RESISTANT GLO | Oct 04, 1991 | Substantially Equivalent | MEDICAL ARMOR CORP. |
| K910890 | NON-STERILE CLINICAL STYLE PARADERM GLOVE LINER | Jun 27, 1991 | Substantially Equivalent | LOVELL-SCHENCK, INC. |
| K911742 | OP-D-OP VISOR SHIELDS | Jun 07, 1991 | Substantially Equivalent | OP-D-OP, INC. |
| K904903 | PARADERM(TM) SURGEON'S GLOVE ACCESSORY | Jan 08, 1991 | Substantially Equivalent | LOVELL-SCHENCK, INC. |
| K900425 | SURGICAL COTTON GLOVES | Sep 07, 1990 | Substantially Equivalent | ALLO PRO CORP. |
| K902633 | CUT RESISTANT GLOVE LINER | Jul 27, 1990 | Substantially Equivalent | BIOMET, INC. |
| K901221 | PHYSICIAN BARRIER GLOVE, SURGICAL | Jul 10, 1990 | Substantially Equivalent | DYNAMIC MARKETING ENT. |
| K902016 | MODIFIED AOR-SULLIVAN PROTECTIVE OVERGLOVE | May 16, 1990 | Substantially Equivalent | AOR-SULLIVAN |
| K900310 | REPEL SURGICAL GLOVE LINERS | Mar 01, 1990 | Substantially Equivalent | DEPUY-RAYNHAM |
| K894064 | STERILE HAND COVER | Aug 11, 1989 | Substantially Equivalent | SAGE PRODUCTS, INC. |
| K893842 | CYSTO APRONS IN VARIOUS SIZES | Aug 02, 1989 | Substantially Equivalent | BEMISS JASON CORP. |
| K893118 | AOR-SULLIVAN PROTECTIVE OVERGLOVE | Jun 01, 1989 | Substantially Equivalent | AOR-SULLIVAN |
| K880440 | PROTECT-AIDS AUTOPSY UNDERGLOVE | Oct 11, 1988 | Substantially Equivalent | MEDICAL ARMOR CORP. |
| K880439 | PROTECT-AIDS UNDERGLOVE | Oct 11, 1988 | Substantially Equivalent | MEDICAL ARMOR CORP. |
FEI Numbers
This FDA classification entry is associated with 877 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 878 registration numbers. Click on an entry to view related FDA registrations.