Browse hierarchy: [General, Plastic Surgery (SU)](/submissions/SU) → [Subpart E — Surgical Devices](/submissions/SU/subpart-e%E2%80%94surgical-devices) → [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) → MMP — Cover, Barrier, Protective # MMP · Cover, Barrier, Protective _General, Plastic Surgery · 21 CFR 878.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP ## Overview - **Product Code:** MMP - **Device Name:** Cover, Barrier, Protective - **Regulation:** [21 CFR 878.4370](/submissions/SU/subpart-e%E2%80%94surgical-devices/878.4370) - **Device Class:** 2 - **Review Panel:** [General, Plastic Surgery](/submissions/SU) - **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. ## Recent Cleared Devices (15 of 15) | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K091178](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K091178.md) | MTP DISPOSABLE EQUIPMENT COVERS, KARL STORZ 15 TOUCH SCREEN | Mtp Medical Technical Promotion GmbH | Jul 31, 2009 | SESE | | [K043234](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K043234.md) | LIGHT DRAPE | Wrapped IN Comfort | May 25, 2005 | SESE | | [K041501](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K041501.md) | GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS | Guangzhou Fortunique , Ltd. | Nov 30, 2004 | SESE | | [K040794](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K040794.md) | INCUBATOR CAPE | Wrapped IN Comfort | Jun 10, 2004 | SESE | | [K032065](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K032065.md) | MEDLINE BAND BAGS AND EQUIPMENT COVERS | Medline Industries, Inc. | Sep 22, 2003 | SESE | | [K023540](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K023540.md) | SNAP KOVER, MODEL 01-2020; SNAP KAPS, MODEL 03-KP09 | Valumed | Feb 4, 2003 | SESE | | [K014239](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K014239.md) | MEDSURG EQUIPMENT COVERS | International Medsurg Connection | Feb 19, 2002 | SESE | | [K970885](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K970885.md) | ULTRASOUND SYSTEMS DRAPE | Protek Medical Products, Inc. | Sep 22, 1997 | SESE | | [K962288](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K962288.md) | COVER-ALL, DRAPE-IT-ALL, CHAIR SLEVE, X-RAY SLEEVE, HEADREST COVER | Pinnacle Products, Inc. | Jan 30, 1997 | SESE | | [K961699](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K961699.md) | EQUIPMENT COVERS | United States Surgical, A Division of Tyco Healthc | Aug 23, 1996 | SESE | | [K952241](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K952241.md) | PROTOUCH OVERGLOVE | Cottrell, Ltd. | Aug 7, 1995 | SESE | | [K931417](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K931417.md) | STERILE EQUIPMENT COVERS | Custom Medical Products, Ltd. | Jul 6, 1995 | SESE | | [K944198](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K944198.md) | SURGICAL MICROSCOPE DRAPE | Hydro-Med Products, Inc. | Nov 27, 1994 | SESE | | [K930552](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K930552.md) | STERILE BARRIER SLEEVE AND COVER | Patient Safety Products, Inc. | Jul 5, 1994 | SESE | | [K820692](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP/K820692.md) | BANDBAG, WRAP, STERILE | Contour Fabricators, Inc. | May 3, 1982 | SESE | ## Top Applicants - Wrapped IN Comfort — 2 clearances - Contour Fabricators, Inc. — 1 clearance - Cottrell, Ltd. — 1 clearance - Custom Medical Products, Ltd. — 1 clearance - Guangzhou Fortunique , Ltd. — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/MMP) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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