Identity
- Trade Name
- Promax OR Gowns FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST (SR 16518) FDA UDI
- Model / Reference
- 75650863 FDA UDI
- Description
- OR GWN PROMAX KNIT AQUA 2XL - SNPS @ NK/TT WST (SR 16518) FDA UDI
Identifiers
- Catalog Number
- 75650863 FDA UDI
- Primary DI / UDI-DI
- 00634916189575 FDA UDI
- 510(k) Number
- K041540 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, reusable FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Surgical gown, reusable
Promax OR Gowns by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K041540 also covers:
- ProMax Surgical Gown — STANDARD TEXTILE CO., INC.
- ProMax Surgical Gown — STANDARD TEXTILE CO., INC.
- ProMax Surgical Gown — STANDARD TEXTILE CO., INC.
- ProMax Surgical Gown — STANDARD TEXTILE CO., INC.
- Promax Backless Pathology Gown — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
- Promax OR Gowns — STANDARD TEXTILE CO., INC.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI 78b10642-06cb-497c-a4fe-7aa9f77e7b1f 36 fields · synced May 30, 2026