| Sponsor | Clearances | Last 12 mo | Most recent |
|---|---|---|---|
| PolyConversions, Inc. | 3 | 2 | 2026-08-11 |
| Azac Group | 1 | 0 | 2025-01-13 |
| Cadillac Products, Inc. | 1 | 0 | 2021-12-15 |
| Dukal Corporation | 1 | 0 | 2022-03-30 |
| Kenpax International Limited | 1 | 0 | 2023-08-08 |
| Dong Nai Garment Corporation (Donagamex) | 1 | 0 | 2021-12-17 |
| Medline Industries, LP | 1 | 0 | 2024-03-05 |
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 |
| Date | K-number | Sponsor | Device |
|---|---|---|---|
| 2026-08-11 | K261115 | PolyConversions, Inc. | VR® Personal Protective Level 4 Gown (VR Gowns) |
| 2025-12-16 | K252940 | PolyConversions, Inc. | VR® Personal Protective Level 3 Gown (VR Gowns) |
| 2025-01-13 | K242689 | Azac Group | AAMI Level 4 Protective; Gown |
| 2024-03-05 | K233526 | Medline Industries, LP | Medline Open-back Level 3 Protective Gown |
| 2023-08-11 | K230384 | PolyConversions, Inc. | PolyWear® Personal Protective Level 3 Gown |
| 2023-08-08 | K222128 | Kenpax International Limited | Protective Gown AAMI Level 4 |
| 2022-03-30 | K212464 | Dukal Corporation | Dukal Corporation AAMI Level 4 Open-Back Protective Gown |
| 2021-12-17 | K203821 | Dong Nai Garment Corporation (Donagamex) | Donagamex Blue Performance Protective Gown |
| 2021-12-15 | K210405 | Cadillac Products, Inc. | ProTEC-USA EZDoff Gown |