FDA.reportPublic FDA data

ASTM Level 2 Surgical Face Mask

Primary DI
00850019294002
Brand
ASTM Level 2 Surgical Face Mask
Company
Premier Guard Usa, LLC
Model
20-1003-SFM2
Device description
3-ply, single-use disposable surgical mask with an ASTM Level 2 rating. Made with elastic ear loops that do not contain natural rubber latex. Carton 50 pcs
Published
2021-11-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
FXXMask, Surgical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FXXMask, SurgicalGeneral, Plastic Surgery2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202595000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202595000Premier Guard USA 3 Layer Ear Loop ASTM Level 3 Surgical Face MaskPremier Guard USA, LLC2021-01-21FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20850019294006PackageGS140In Commercial Distribution
00850019294002PrimaryGS10
00850019294347Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085001929400620850019294006
00850019294002008500192940028500192940020850019294002
00850019294347008500192943478500192943470850019294347

GMDN Terms#

Term, Definition table
TermDefinition
Surgical/medical face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a healthcare worker to permit normal breathing while protecting the patient and wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) during medical procedures and patient examination; it is not a form-shaped filtering device (i.e., not a respirator). It is made of a flexible, porous fabric or paper material and is typically secured using elastic head straps or ties; it may incorporate a forming nosepiece (metal wire) and/or transparent face/eye visor intended to protect the upper face/eyes from debris/fluid. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-706-1231Glenn.Ferreri@premierguardusa.com

Regulatory Flags#

DUNS number
117537165
Device count
50
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850019294019ASTM Level 3 Surgical Face Mask20-1002-SFM32021-05-10
00850019294026Face Mask20-1001-FM2022-04-22
00850019294156ASTM Level 3 Surgical Face Mask20-1002-SFM32022-04-22
10850019294016ASTM Level 3 Surgical Face Mask case20-1002-SFM32022-04-22
20850019294006ASTM Level 2 Surgical Face Mask Case20-1003-SFM22022-04-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06922820992584GraidRfx+Care Manufacturing Co., Ltd.FXX2026-06-09
16980077680217AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680224AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680231AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680248AOKAOK TOOLING LIMITEDFXX2026-06-08
16980077680170AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680187AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680194AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680200AOKAOK TOOLING LIMITEDFXX2026-06-05
16980077680149AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680156AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680163AOKAOK TOOLING LIMITEDFXX2026-06-04
16980077680101AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680118AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680125AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680132AOKAOK TOOLING LIMITEDFXX2026-06-03
16980077680071AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680088AOKAOK TOOLING LIMITEDFXX2026-05-28
16980077680095AOKAOK TOOLING LIMITEDFXX2026-05-28
00681131106108EquateWAL-MART STORES, INC.FXX2026-02-25
00681131106092EquateWAL-MART STORES, INC.FXX2026-02-25
08809755250171KP Protective Face Mask KP trading Co., Ltd.FXX2026-02-19
10097604555514Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2025-07-28
10371347011606Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011613Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10371347011620Advance Dental ProductsThe Atlanta Dental Supply CompanyFXX2024-03-01
10097604543320Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604553022Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604563229Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19
10097604573624Tronex International, Inc.TRONEX INTERNATIONAL, INC.FXX2024-01-19