QPC — Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection Class II
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 |