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ASTM Level 2 Surgical Face Mask 20-1003-SFM2

by Premier Guard USA, LLC

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850019294002 UDI-DI Date24 Nov 2021ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ASTM Level 2 Surgical Face Mask
Generic Name
Surgical/medical face mask, non-antimicrobial, single-use
Model / Reference
20-1003-SFM2
Primary DI / UDI-DI
00850019294002
510(k) Number
FDA Product Code
FXX
GMDN Term
Surgical/medical face mask, non-antimicrobial, single-use
Device Class
Class II
Regulation Number
878.4040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Surgical/medical face mask, non-antimicrobial, single-use

Cleared under the same submission (K202595)

Other devices from Premier Guard USA, LLC

Properties

  • Single Use
  • Over-the-Counter
  • Lot / Batch Number

Other properties (11)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No