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-U07 (White) 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
- 06973824910739 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
Similar devices
Also classified as Public face mask, single-use.
- JMU — JMU DENTAL, INC · Class II
- Child Face Masks — Dynarex Corp. · Class I
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- JMU — JMU DENTAL, INC · Class II
- Trinity Sterile, Inc. — TRINITY STERILE, INC. · N
- Halyard — O&M HALYARD, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
- Rospital Productos Medicos — ATLAS MEDICAL PRODUCTS LLC · Class II
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Guangzhou Zhengkang Medical Equipment Co., Ltd
Sources (1)
- FDA UDI f57cec19-c2e3-429d-b048-7d798d7cc15a 35 fields · synced May 31, 2026