Identity
- Trade Name
- ComPel OR Gown FDA UDI
- Generic Name
- Surgical gown, reusable FDA UDI
- Device Name
- 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body FDA UDI
- Model / Reference
- 75647454 FDA UDI
- Description
- 2-Ply Front/Sleeves Aqua Compel MLR and White ComPel MLR with Negastat, 1-Ply Aqua MLR Comfort Panel Backs, Snap Closures at Neck, Tie Closures at Waist, Circumferentially Offset Sleeves, Overcast Safety Stitch Body FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634916788358 FDA UDI
- 510(k) Number
- K041539 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
ComPel OR Gown by Standard Textile Co., Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical gown, reusable.
- Encompass — Encompass Group, L.L.C. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Lac-Mac — Lac Mac, Ltd. · Class II
- NOVO Health Services, LLC — NOVO HEALTH SERVICES, LLC · Class II
- SRI Healthcare — Elevate Textiles · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Lac-Mac — Lac Mac, Ltd. · Class II
Cleared under the same submission
K041539 also covers:
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — STANDARD TEXTILE CO., INC.
- ComPel Surgical Gown — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI e588475f-c1c2-42de-af58-71509190be02 35 fields · synced May 30, 2026