Identity
- Trade Name
- All Pro FDA UDI
- Generic Name
- Surgical/medical respirator, non-antimicrobial, single-use FDA UDI
- Device Name
- N95 mask, 20 masks per box, 12 boxes per master case FDA UDI
- Model / Reference
- 8610A FDA UDI
- Description
- N95 mask, 20 masks per box, 12 boxes per master case FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10016659570150 FDA UDI
- 510(k) Number
- K061375 FDA UDI
- FDA Product Code
- MSH 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
No
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
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Surgical/medical respirator, non-antimicrobial, single-use
All Pro by Bunzl USA Holdings LLC — 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
K061375 also covers:
- SAS Safety / Gerson — Bunzl USA Holdings LLC
- Crosstex™ Isolator™ Duckbill N95 Surgical Respirator — CROSSTEX INTERNATIONAL, INC.
- Crosstex™ Isolator™ Molded N95 Surgical Respirator — CROSSTEX INTERNATIONAL, INC.
- LEADER — Cardinal Health 110, Inc.
- GERSON — LOUIS M. GERSON CO., INC.
- Marketlab Inc — MARKETLAB INC.
- Marketlab Inc — MARKETLAB INC.
- PureLife N95 — PURELIFE, LLC
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
- Bunzl USA Holdings LLC
Sources (1)
- FDA UDI 8b27ff2f-1929-4c16-b908-8f1831dc9613 34 fields · synced Jun 8, 2026