Identity
- Trade Name
- KF94 PROTECTION MASKS FDA UDI
- Generic Name
- Public face mask, single-use FDA UDI
- Device Name
- 5-layer structure Smooth ear strap Skin-friendly no-woven fabric Protect from dust and sunlight Use when traveling to polluted areas, during times of bad air quality. FDA UDI
- Model / Reference
- 1 FDA UDI
- Description
- 5-layer structure Smooth ear strap Skin-friendly no-woven fabric Protect from dust and sunlight Use when traveling to polluted areas, during times of bad air quality. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00860005026500 FDA UDI
- FDA Product Code
- MSH 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
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
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Public face mask, single-use
Kf94 Protection Masks by Song Hong Garment Joint Stock Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Halyard — O&M HALYARD, INC. · Class II
- Medline — MEDLINE INDUSTRIES, INC. · Class II
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
- Song Hong Garment Joint Stock Co.
Sources (1)
- FDA UDI dff0f894-de6e-4975-b1ef-a858eecdba6e 33 fields · synced May 30, 2026