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Disposable Isolation Gown
EUDAMEDFDA UDIClass I (EU MDR)
Ref XLModel S,M,L,XL,XXL,XXXL,XXXXL
Identity
- Trade Name
- Zhibo FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Disposable Isolation Gown EUDAMEDIt is applicable to the health protection of the wearer in the ordinary medical environment without the risk of liquid and splashing. FDA UDI
- Model / Reference
- S,M,L,XL,XXL,XXXL,XXXXL EUDAMEDXL EUDAMED1 FDA UDI
- Description
- It is applicable to the health protection of the wearer in the ordinary medical environment without the risk of liquid and splashing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973244780004 EUDAMEDFDA UDI
- Basic UDI-DI
- 697324478igown0077R EUDAMED
- 510(k) Number
- K182514 FDA UDI
- FDA Product Code
- FXX FDA UDI
- EMDN Code
- T0299 PROTECTION DRAPES AND GARMENTS - OTHER EUDAMED
- GMDN Term
- Surgical/medical face mask, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4040 FDA UDI
- Market of Registration
- Austria EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Disposable Isolation Gown by Xiantao Zhibo Non-woven Products Co., Ltd — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 697324478igown0077R | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Xiantao Zhibo Non-woven Products Co., Ltd
- EUDAMED SRN
- CN-MF-000008760
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 39b5e87c-8061-4cfc-bd3e-a57b875288bd 61 fields · synced Oct 6, 2026
- FDA UDI 2a034cab-4345-4722-9163-7178fc600ce8 34 fields · synced May 30, 2026