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Plus Medical Cover Gown
FDA 510(k)FDA UDIClass II (US FDA 510(k))
510(k) K213177
Identity
- Trade Name
- Plus Medical Cover Gown FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Model / Reference
- PM4407PG FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973062321427 FDA UDI
- 510(k) Number
- FDA Product Code
- FYA FDA 510(k)FDA UDI
- GMDN Term
- Surgical gown, single-use FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4040 FDA 510(k)
- Regulation Number
- 878.4040 FDA 510(k)FDA UDI
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- 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
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Ethylene Oxide FDA UDI
Plus Medical Cover Gown by Foshan Nanhai Plus Medical Co., Ltd — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K213177 | Class II | Active |
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Manufacturer
- Manufacturer
- Foshan Nanhai Plus Medical Co., Ltd
- FDA Applicant
- Foshan Nanhai Plus Medical Co, Ltd.
Sources (2)
- FDA 510(k) K213177 24 fields · synced Jun 18, 2026
- FDA UDI 04aea25f-69ae-4231-96a3-dc19369644bc 33 fields · synced May 27, 2026