KKX · Drape, Surgical
General, Plastic Surgery · 21 CFR 878.4370 · Class 2
Overview
| Product Code | KKX |
|---|---|
| Device Name | Drape, Surgical |
| 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.
Recent Cleared Devices (20 of 450)
Showing 20 most recent of 450 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K230645 | BeneHold Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | Oct 25, 2023 | SESE |
| K222578 | 3M Ioban CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | May 18, 2023 | SESE |
| K202208 | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | Jul 30, 2021 | SESE |
| K200238 | ControlRad Sterile Cover | Controlrad, Inc. | Apr 26, 2020 | SESE |
| K163556 | MediClear PreOp | Covalontechnologies, Inc. | Sep 14, 2017 | SESE |
| K133080 | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | Jun 24, 2015 | SESE |
| K141324 | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Apr 14, 2015 | SESE |
| K140195 | SURGICAL DRAPE | Griffith-Lucas, LLC | Sep 10, 2014 | SESE |
| K140330 | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | Aug 18, 2014 | SESE |
| K141438 | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | Aug 14, 2014 | SESE |
| K140250 | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | Jul 25, 2014 | SESE |
| K140064 | SURGISLEEVE WOUND PROTECTOR | Covidien | Mar 12, 2014 | SESE |
| K131571 | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | Jan 31, 2014 | SESE |
| K130404 | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | Jul 5, 2013 | SESE |
| K121436 | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | Jun 6, 2013 | SESE |
| K121919 | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | Feb 14, 2013 | SESE |
| K122000 | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | Changzhou Holymed Products Co., Ltd. | Dec 12, 2012 | SESE |
| K112378 | COBES SURGICAL DRAPE | Cobes Industries Co., Ltd. | May 8, 2012 | SESE |
| K111458 | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | Gri Medical & Electronic Technology Co., Ltd. | Dec 1, 2011 | SESE |
| K112136 | TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE | Kunshan Jiehong Nonwoven Product Co., Ltd. | Sep 29, 2011 | SESE |
Top Applicants
- Surgikos, Inc. — 30 clearances
- Procter & Gamble Mfg. Co. — 14 clearances
- Deroyal Industries, Inc. — 11 clearances
- Customed, Inc. — 11 clearances
- Allegiance Healthcare Corp. — 9 clearances
