Identity
- Trade Name
- ZhengKang FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. FDA UDI
- Model / Reference
- ZKM-U05 (Black) FDA UDI
- Description
- Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. The Medical Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06973824910692 FDA UDI
- 510(k) Number
- K222204 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Public face mask, 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
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
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Public face mask, single-use
ZhengKang by Guangzhou Zhengkang Medical Equipment Co., Ltd — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- JMU — JMU DENTAL, INC · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
- Halyard — O&M HALYARD, INC. · Class II
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Cleared under the same submission
K222204 also covers:
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
- Guangzhou Zhengkang Medical Equipment Co., Ltd
Sources (1)
- FDA UDI a4d5ef1d-266e-4345-8668-0a92e7f85070 35 fields · synced May 30, 2026