MMP · Cover, Barrier, Protective
General, Plastic Surgery · 21 CFR 878.4370 · Class 2
Overview
| Product Code | MMP |
|---|---|
| Device Name | Cover, Barrier, Protective |
| Regulation | 21 CFR 878.4370 |
| Device Class | Class 2 |
| Review Panel | General, Plastic Surgery |
| 3rd-Party Reviewable | Yes |
Identification
A surgical drape and drape accessories is a device made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The device includes a plastic wound protector that may adhere to the skin around a surgical incision or be placed in a wound to cover its exposed edges, and a latex drape with a self-retaining finger cot that is intended to allow repeated insertion of the surgeon's finger into the rectum during performance of a transurethral prostatectomy.
Classification Rationale
Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Special Controls
*Classification.* Class II (special controls). The device, when it is an ear, nose, and throat surgical drape, a latex sheet drape with self-retaining finger cot, a disposable urological drape, a Kelly pad, an ophthalmic patient drape, an ophthalmic microscope drape, an internal drape retention ring (wound protector), or a surgical drape that does not include an antimicrobial agent, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.
Cleared Devices (15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K091178 | MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN | Mtp Medical Technical Promotion GmbH | Jul 31, 2009 | SESE |
| K043234 | LIGHT DRAPE | Wrapped IN Comfort | May 25, 2005 | SESE |
| K041501 | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | Guangzhou Fortunique , Ltd. | Nov 30, 2004 | SESE |
| K040794 | INCUBATOR CAPE | Wrapped IN Comfort | Jun 10, 2004 | SESE |
| K032065 | MEDLINE BAND BAGS AND EQUIPMENT COVERS | Medline Industries, Inc. | Sep 22, 2003 | SESE |
| K023540 | SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 | Valumed | Feb 4, 2003 | SESE |
| K014239 | MEDSURG EQUIPMENT COVERS | International Medsurg Connection | Feb 19, 2002 | SESE |
| K970885 | ULTRASOUND SYSTEMS DRAPE | Protek Medical Products, Inc. | Sep 22, 1997 | SESE |
| K962288 | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER | Pinnacle Products, Inc. | Jan 30, 1997 | SESE |
| K961699 | EQUIPMENT COVERS | United States Surgical, A Division of Tyco Healthc | Aug 23, 1996 | SESE |
| K952241 | PROTOUCH OVERGLOVE | Cottrell, Ltd. | Aug 7, 1995 | SESE |
| K931417 | STERILE EQUIPMENT COVERS | Custom Medical Products, Ltd. | Jul 6, 1995 | SESE |
| K944198 | SURGICAL MICROSCOPE DRAPE | Hydro-Med Products, Inc. | Nov 27, 1994 | SESE |
| K930552 | STERILE BARRIER SLEEVE AND COVER | Patient Safety Products, Inc. | Jul 5, 1994 | SESE |
| K820692 | BANDBAG, WRAP, STERILE | Contour Fabricators, Inc. | May 3, 1982 | SESE |
Top Applicants
- Wrapped IN Comfort — 2 clearances
- Valumed — 1 clearance
- United States Surgical, A Division of Tyco Healthc — 1 clearance
- Protek Medical Products, Inc. — 1 clearance
- Pinnacle Products, Inc. — 1 clearance
