Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
The Gown (Non-Sterile, Non-Isolation, Moderate or High Barrier Protection) is a protective garment 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 or antiviral agents or claims are excluded from this classification. This device is classified as FDA Class 2, requiring 510(k) clearance, under regulation 878.4040 in the General and Plastic Surgery specialty. It carries product code QPC and is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QPC
- Device Class
- FDA class 2
- Regulation Number
- 878.4040
- Medical Specialty
- General, Plastic Surgery
- Review Panel
- HO
- Submission Type
- 1
Device Characteristics
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.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 10 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K252940 | VR® Personal Protective Level 3 Gown (VR Gowns) | Dec 16, 2025 | Substantially Equivalent | PolyConversions, Inc. |
| K242689 | AAMI Level 4 Protective; Gown | Jan 13, 2025 | Substantially Equivalent | Azac Group |
| K233526 | Medline Open-back Level 3 Protective Gown | Mar 05, 2024 | Substantially Equivalent | Medline Industries, LP |
| K230384 | PolyWear® Personal Protective Level 3 Gown | Aug 11, 2023 | Substantially Equivalent | PolyConversions, Inc. |
| K222128 | Protective Gown AAMI Level 4 | Aug 08, 2023 | Substantially Equivalent | Kenpax International Limited |
| K212464 | Dukal Corporation AAMI Level 4 Open-Back Protective Gown | Mar 30, 2022 | Substantially Equivalent | Dukal Corporation |
| K203821 | Donagamex Blue Performance Protective Gown | Dec 17, 2021 | Substantially Equivalent | Dong Nai Garment Corporation (Donagamex) |
| K210405 | ProTEC-USA EZDoff Gown | Dec 15, 2021 | Substantially Equivalent | Cadillac Products, Inc. |
| K182830 | Cardinal HealthTM Poly-Coated Open-Back Protective Gown | Apr 26, 2019 | Substantially Equivalent | Cardinal Health200, LLC |
| K160337 | Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns | Jul 07, 2017 | Substantially Equivalent | Bam Corporation Limited |
FEI Numbers
This FDA classification entry is associated with 18 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 18 registration numbers. Click on an entry to view related FDA registrations.