Identity
- Trade Name
- SURGICAL GOWN FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- SURGICAL GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS FDA UDI
- Model / Reference
- 28025 FDA UDI
- Description
- SURGICAL GOWN, PROTECT THE WEARER FROM THE SPREAD OF INFECTION OR ILLNESS, CREATING A BARRIER AGAINST POTENTIALLY INFECTIOUS FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06950471300083 FDA UDI
- 510(k) Number
- K100971 FDA UDI
- FDA Product Code
- FYA FDA UDI
- GMDN Term
- Surgical gown, single-use 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
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical gown, single-use
Surgical Gown by Hangzhou A-Tek Medical & Textiles Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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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
- Hangzhou A-Tek Medical & Textiles Co., Ltd.
Sources (1)
- FDA UDI 8cc9c0e4-55c7-41ec-96f1-29ccd362e822 34 fields · synced May 31, 2026