Identity
- Trade Name
- PU YUAN FDA UDI
- Generic Name
- Surgical gown, single-use FDA UDI
- Device Name
- Surgical protection in the operating room FDA UDI
- Model / Reference
- SB2F-HoodGown-XL-EL-M-FP FDA UDI
- Description
- Surgical protection in the operating room FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06921825701481 FDA UDI
- 510(k) Number
- K222403 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
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
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
Pu Yuan by Guangzhou Fuzelong Hygiene Material Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Also classified as Surgical gown, single-use.
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- T7 — Stryker Corp. · Class II
Cleared under the same submission
K222403 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Guangzhou Fuzelong Hygiene Material Co., Ltd.
Sources (2)
- FDA UDI 47006ec6-52fe-45d0-ad1c-4982c7af1746 35 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 1, 2026