Cover, Barrier, Protective
The Protective Barrier Cover is a sterile or non-sterile covering material applied over wounds, incisions, or vulnerable tissue areas to protect them from external contamination, friction, or environmental exposure, used in general surgical and wound management settings. Classified as a Class 2 device under 21 CFR 878.4370 within the General and Plastic Surgery specialty, it requires 510(k) premarket notification. It carries no implant or life-sustaining flags.
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Basic Information
- Product Code
- MMP
- Device Class
- FDA class 2
- Regulation Number
- 878.4370
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 15 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K091178 | MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN | Jul 31, 2009 | Substantially Equivalent | Mtp Medical Technical Promotion GmbH |
| K043234 | LIGHT DRAPE | May 25, 2005 | Substantially Equivalent | Wrapped IN Comfort |
| K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | Nov 30, 2004 | Substantially Equivalent | Guangzhou Fortunique , Ltd. |
| K040794 | INCUBATOR CAPE | Jun 10, 2004 | Substantially Equivalent | Wrapped IN Comfort |
| K032065 | MEDLINE BAND BAGS AND EQUIPMENT COVERS | Sep 22, 2003 | Substantially Equivalent | Medline Industries, Inc. |
| K023540 | SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 | Feb 04, 2003 | Substantially Equivalent | Valumed |
| K014239 | MEDSURG EQUIPMENT COVERS | Feb 19, 2002 | Substantially Equivalent | International Medsurg Connection |
| K970885 | ULTRASOUND SYSTEMS DRAPE | Sep 22, 1997 | Substantially Equivalent | Protek Medical Products, Inc. |
| K962288 | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER | Jan 30, 1997 | Substantially Equivalent | Pinnacle Products, Inc. |
| K961699 | EQUIPMENT COVERS | Aug 23, 1996 | Substantially Equivalent | United States Surgical, A Division of Tyco Healthc |
| K952241 | PROTOUCH OVERGLOVE | Aug 07, 1995 | Substantially Equivalent | Cottrell, Ltd. |
| K931417 | STERILE EQUIPMENT COVERS | Jul 06, 1995 | Substantially Equivalent | Custom Medical Products, Ltd. |
| K944198 | SURGICAL MICROSCOPE DRAPE | Nov 27, 1994 | Substantially Equivalent | Hydro-Med Products, Inc. |
| K930552 | STERILE BARRIER SLEEVE AND COVER | Jul 05, 1994 | Substantially Equivalent | Patient Safety Products, Inc. |
| K820692 | BANDBAG, WRAP, STERILE | May 03, 1982 | Substantially Equivalent | Contour Fabricators, Inc. |
FEI Numbers
This FDA classification entry is associated with 55 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 55 registration numbers. Click on an entry to view related FDA registrations.