Identity
- Trade Name
- ProMax Surgical Gown FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Size Large FDA UDI
- Model / Reference
- 75615075 FDA UDI
- Description
- ProMax Surgical Gown, MLR Front Yoke with Kaumograph, Comfort Panel Back with Negastat, Color Coded Neck Binding, Snap Closures at Neck, Color Coded Tie Closures at Waist, With QCM, Size Large FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634916819021 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 Surgical Gown 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 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.
- 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 e4bb956b-3bb2-4b08-92e2-be8921c82927 35 fields · synced May 30, 2026