PEM · Dental Barriers And Sleeves
General, Plastic Surgery · 21 CFR 878.4370 · Class 2
Overview
| Product Code | PEM |
|---|---|
| Device Name | Dental Barriers And Sleeves |
| 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 (15 of 15)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K250735 | Dental Barrier and Sleeves | Fomed Industries, Inc. | Jun 10, 2025 | SESE |
| K250606 | Dental Barrier and Sleeves | Yueying Medical Instruments (Langfang) Co., Ltd. | May 29, 2025 | SESE |
| K242435 | Dental Barrier and Sleeves | Wellmed Dental Medical Supply Co., Ltd. | Oct 18, 2024 | SESE |
| K233918 | Dental Barrier and Sleeves | Yongqing Huaguan Dental Instruments Factory | May 9, 2024 | SESE |
| K220662 | Disposable Barrier Sleeves | Premium Plus (Dongguan) Limited | May 11, 2022 | SESE |
| K211026 | Minitube Dentasleeve Protective Barrier Sleeves | Minitube AB | Aug 3, 2021 | SESE |
| K201604 | Plasdent Disposable Barrier Sleeves and Barrier Film | Plasdent Corporation | Dec 23, 2020 | SESE |
| K191448 | Barrier Sleeves | Ivoclar Vivadent, AG | Oct 8, 2019 | SESE |
| K190484 | BH Medical Dental Barrier Sleeves and Barrier Film | Bh Medical Products Co., Ltd. | Sep 10, 2019 | SESE |
| K190949 | ScanX Barrier Envelopes | Air Techniques, Inc. | Jul 26, 2019 | SESE |
| K183263 | UNiPACK Barrier Sleeve and Barrier Film and UNiGLIDE Barrier Envelope | Unipack Medical Corporation | Jun 14, 2019 | SESE |
| K163447 | Premium Plus Disposable Barrier Sleeve | Premium Plus International Limited | Jun 20, 2017 | SESE |
| K160232 | Disposable Barrier Sleeves and Covers | Dentsply International, Inc. | Jun 7, 2016 | SESE |
| K151123 | Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film | Pac-Dent International, Inc. | Mar 3, 2016 | SESE |
| K132953 | 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
