Identity
- Trade Name
- Generic Polyester Isolation Gown FDA UDI
- Generic Name
- Isolation gown, reusable FDA UDI
- Device Name
- EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White, Size XL, AP7036 Non-Linting Cuffs and Cuff Shields FDA UDI
- Model / Reference
- 661Y4974 FDA UDI
- Description
- EasyRelease, Generic Polyester Isolation Gown, Bound Neck, Velcro Hook & Loop Closures at Neck/Waist, Long Sleeves with Natural White, Size XL, AP7036 Non-Linting Cuffs and Cuff Shields FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00634916801156 FDA UDI
- FDA Product Code
- OEA FDA UDI
- GMDN Term
- Isolation gown, reusable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Commercial Distribution
- Not 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
Yes
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
Generic Polyester Isolation Gown by Standard Textile Co., Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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 I | Pending data |
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Manufacturer
- Manufacturer
- Standard Textile Co., Inc.
Sources (1)
- FDA UDI bf926ea9-0929-430c-9d1c-2a24e957dfa8 35 fields · synced Jun 1, 2026