Device class
Class II
Regulation 878.4040
Total clearances
10
2021-12-15 → 2026-09-11
Definition
What is Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection
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.
Classification details
Medical specialty
General, Plastic Surgery
Regulation number
878.4040
Trend
Clearance volume by quarter
Players
Top sponsors in this product code
Reimbursement
Likely billing codes (AI-inferred · verify with billing)
Healthcare providers using this device would typically bill under these HCPCS Level II
(alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku;
official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available.
Always verify with billing/coding teams before relying on these.
| Code | Type | Description | Confidence | Rationale |
| A4390 |
HCPCS
|
Ostomy pouch, drainable, with extended wear barrier attached, with built-in convexity (1 piece), each ✓ CMS-verified description |
High
|
Gown, isolation; standard HCPCS code for protective gowns including non-sterile barrier protection gowns |
| A6403 |
HCPCS
|
Gauze, non-impregnated, sterile, pad size more than 16 sq. in. less than or equal to 48 sq. in., without adhesive border, each dressing ✓ CMS-verified description |
Medium
|
Protective barrier gown/apron; alternative supply code for protective gowning |
Pulse
Most recent 510(k) clearances