Identity
- Trade Name
- Strong Manufacturers FDA UDI
- Generic Name
- Surgical/medical face mask, single-use FDA UDI
- Device Name
- Earloop procedure mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 1, non-sterile, case of 300 ea FDA UDI
- Model / Reference
- 5301 FDA UDI
- Description
- Earloop procedure mask, blue, contains forming nosepiece (metal wire), ASTM F2100 Level 1, non-sterile, case of 300 ea FDA UDI
Identifiers
- Catalog Number
- 5301 FDA UDI
- Primary DI / UDI-DI
- 00853927007733 FDA UDI
- 510(k) Number
- K214087 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical 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: Surgical/medical face mask, single-use
Strong Manufacturers by Strong Medical Partners LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K214087 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
- Strong Medical Partners LLC
Sources (1)
- FDA UDI fd746893-1a99-4aad-92f4-b8847eeafc2c 37 fields · synced Jun 8, 2026