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) → PEM — Dental Barriers And Sleeves # PEM · Dental Barriers And Sleeves _General, Plastic Surgery · 21 CFR 878.4370 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM ## Overview - **Product Code:** PEM - **Device Name:** Dental Barriers And Sleeves - **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 | | --- | --- | --- | --- | --- | | [K250735](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K250735.md) | Dental Barrier and Sleeves | Fomed Industries, Inc. | Jun 10, 2025 | SESE | | [K250606](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K250606.md) | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | May 29, 2025 | SESE | | [K242435](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K242435.md) | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | Oct 18, 2024 | SESE | | [K233918](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K233918.md) | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | May 9, 2024 | SESE | | [K220662](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K220662.md) | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | May 11, 2022 | SESE | | [K211026](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K211026.md) | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | Aug 3, 2021 | SESE | | [K201604](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K201604.md) | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | Dec 23, 2020 | SESE | | [K191448](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K191448.md) | Barrier Sleeves | Ivoclar Vivadent, AG | Oct 8, 2019 | SESE | | [K190484](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K190484.md) | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | Sep 10, 2019 | SESE | | [K190949](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K190949.md) | ScanX Barrier Envelopes | Air Techniques, Inc. | Jul 26, 2019 | SESE | | [K183263](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K183263.md) | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | Jun 14, 2019 | SESE | | [K163447](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K163447.md) | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | Jun 20, 2017 | SESE | | [K160232](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K160232.md) | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | Jun 7, 2016 | SESE | | [K151123](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K151123.md) | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | Mar 3, 2016 | SESE | | [K132953](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM/K132953.md) | TIDISHEILD | Tidi Products,Llc | Feb 18, 2014 | SESE | ## Top Applicants - Yueying Medical Instruments (Langfang) Co., Ltd. — 1 clearance - Yongqing Huaguan Dental Instruments Factory — 1 clearance - Wellmed Dental Medical Supply Co., Ltd. — 1 clearance - Unipack Medical Corporation — 1 clearance - Tidi Products,Llc — 1 clearance --- **Source:** [https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM](https://fda.innolitics.com/submissions/SU/subpart-e%E2%80%94surgical-devices/PEM) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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