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) → KKX — Drape, Surgical # KKX · Drape, Surgical _General, Plastic Surgery · 21 CFR 878.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX ## Overview - **Product Code:** KKX - **Device Name:** Drape, Surgical - **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 (20 of 450) Showing 20 most recent of 450 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K230645](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K230645.md) | BeneHold™ Surgical Incise Drape with CHG antimicrobial II | Avery Dennison Medical , Ltd. | Oct 25, 2023 | SESE | | [K222578](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K222578.md) | 3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG) | 3M Company | May 18, 2023 | SESE | | [K202208](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K202208.md) | BeneHold Surgical Incise Drape with CHG antimicrobial | Avery Dennison Belgie Bvba | Jul 30, 2021 | SESE | | [K200238](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K200238.md) | ControlRad Sterile Cover | Controlrad, Inc. | Apr 26, 2020 | SESE | | [K163556](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K163556.md) | MediClear PreOp | Covalontechnologies, Inc. | Sep 14, 2017 | SESE | | [K133080](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K133080.md) | Plus Surgical Drapes (EO Sterilized), PMDB-XXX | Foshan Nanhai Plus Medical Co, Ltd. | Jun 24, 2015 | SESE | | [K141324](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K141324.md) | HONGYU DISPOSABLE SURGICAL DRAPES | Weihai Hongyu Nonwoven Fabric Products Co., Ltd. | Apr 14, 2015 | SESE | | [K140195](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K140195.md) | SURGICAL DRAPE | Griffith-Lucas, LLC | Sep 10, 2014 | SESE | | [K140330](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K140330.md) | 3M STERI-DRAPE FABRIC SURGICAL DRAPES | 3M Healthcare | Aug 18, 2014 | SESE | | [K141438](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K141438.md) | WHITNEY MEDICAL SOLUTIONS ESHIELD | Whitney Medical Solutions | Aug 14, 2014 | SESE | | [K140250](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K140250.md) | 3M STERI-DRAPE CHG ANTIMICROBIAL INCISE DRAPE | 3M Healthcare | Jul 25, 2014 | SESE | | [K140064](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K140064.md) | SURGISLEEVE WOUND PROTECTOR | Covidien | Mar 12, 2014 | SESE | | [K131571](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K131571.md) | AVD RIGHT RADIAL DRAPE | Advanced Vascular Dynamics | Jan 31, 2014 | SESE | | [K130404](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K130404.md) | TIBURON SURGICAL DRAPE | Cardinal Health200, LLC | Jul 5, 2013 | SESE | | [K121436](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K121436.md) | DAS MEDICAL EQUIPMENT DRAPES | Das Medical, LLC | Jun 6, 2013 | SESE | | [K121919](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K121919.md) | SURGICAL DRAPE WITH AAMI LIQUID BARRIER LEVEL IV | Exact Medical Manufacturing, Inc. | Feb 14, 2013 | SESE | | [K122000](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K122000.md) | HM SURGICAL DRAPES HM SURGICAL EQUIPMENT COVER | Changzhou Holymed Products Co., Ltd. | Dec 12, 2012 | SESE | | [K112378](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K112378.md) | COBES SURGICAL DRAPE | Cobes Industries Co., Ltd. | May 8, 2012 | SESE | | [K111458](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K111458.md) | GRI STERILE AND NON-STERILE SURGICAL DRAPES AND SURGICAL EQUIPMENT COVERS | Gri Medical & Electronic Technology Co., Ltd. | Dec 1, 2011 | SESE | | [K112136](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX/K112136.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/KKX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com