QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection Class II
FDA product code QPC covers "Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection", a Class II medical device regulated under 21 CFR 878.4040. Submissions are reviewed by the General, Plastic Surgery panel. At least 10 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- QPC
- Device Class
- Class II
- Regulation Number
- 878.4040
- Submission Type
- Review Panel
- HO
- Medical Specialty
- General, Plastic Surgery
- Implant
- No
Definition
A non-sterile, non-isolation gown intended to be worn by healthcare personnel to provide moderate or high barrier protection in non-sterile and non patient isolation situations. Gowns with antimicrobial/antiviral agents or claims are excluded.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252940 | polyconversions | VR® Personal Protective Level 3 Gown (VR Gowns) | December 16, 2025 |
| K242689 | azac group | AAMI Level 4 Protective; Gown | January 13, 2025 |
| K233526 | medline industries | Medline Open-back Level 3 Protective Gown | March 5, 2024 |
| K230384 | polyconversions | PolyWear® Personal Protective Level 3 Gown | August 11, 2023 |
| K222128 | kenpax international limited | Protective Gown AAMI Level 4 | August 8, 2023 |
| K212464 | dukal corporation | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | March 30, 2022 |
| K203821 | dong nai garment corporation (donagamex) | Donagamex Blue Performance Protective Gown | December 17, 2021 |
| K210405 | cadillac products | ProTEC-USA EZDoff Gown | December 15, 2021 |
| K182830 | cardinal health200 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | April 26, 2019 |
| K160337 | bam corporation limited | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | July 7, 2017 |