Identity
- Trade Name
- Criterion FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- MaxiGard SFT Earloop Mask L3, Blue, 50/Box FDA UDI
- Model / Reference
- 5703278 FDA UDI
- Description
- MaxiGard SFT Earloop Mask L3, Blue, 50/Box FDA UDI
Identifiers
- Catalog Number
- 5703278 FDA UDI
- Primary DI / UDI-DI
- 00304040168974 FDA UDI
- 510(k) Number
- K103303 FDA UDI
- FDA Product Code
- FXX FDA UDI
- GMDN Term
- Surgical/medical respirator, non-antimicrobial, 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
Yes
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-use
Criterion by Henry Schein, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Surgical/medical respirator, non-antimicrobial, single-use.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class II
- Pasture A520S Respirator — Pasture Pharma Pte, Ltd. · Class II
- Halyard — O&M HALYARD, INC. · Class II
- Lighthouse Worldwide Solutions Inc — Lighthouse Worldwide Solutions, Inc. · Class II
- Hope — PROGUARD HEALTH INC. · Class II
- Vitacore — Vitacore Industries, Inc. · Class II
- 3M — 3M COMPANY · Class II
- Zhou Medical N95 Respirator Mask — ZHOU MEDICAL SOLUTIONS LLC · Class II
Cleared under the same submission
K103303 also covers:
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Criterion — HENRY SCHEIN, INC.
- Hu-Friedy — HU-FRIEDY MFG CO., LLC
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
- Advance Dental Products — THE ATLANTA DENTAL SUPPLY COMPANY
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
- Henry Schein, Inc.
Sources (1)
- FDA UDI e6e2c6b5-19b0-4ca2-a69a-e7d374dbf7ba 35 fields · synced Jun 1, 2026