FDA.reportPublic FDA data

AOK

Primary DI
16973869540011
Brand
AOK
Company
AOK TOOLING LIMITED
Model
20190019
Device description
Plan Surgical Face Mask
Published
2020-11-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
K201517000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201517000Plain Surgical MaskAok Tooling Limited2020-09-04FXX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
26973869540018PackageGS140In Commercial Distribution
16973869540011PrimaryGS10
06973869540014Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2697386954001826973869540018
1697386954001116973869540011
06973869540014069738695400146973869540014

GMDN Terms#

Term, Definition table
TermDefinition
Public face mask, single-useA flexible, loose-fitting mask designed to be placed over the mouth and/or nose of a member of the general public to permit normal breathing while protecting the wearer from the transfer of large particles (e.g., blood, body fluids, and airborne particulate materials) from the environment; 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). This is a single-use device.

Regulatory Flags#

DUNS number
544325948
Device count
50
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
16980077680217AOK20190039-013-H-XL2026-06-08
16980077680224AOK20190039-013-H-L2026-06-08
16980077680231AOK20190039-013-H-M2026-06-08
16980077680248AOK20190039-013-H-S2026-06-08
16980077680170AOK20190039-013-H-XL2026-06-05
16980077680187AOK20190039-013-H-L2026-06-05
16980077680194AOK20190039-013-H-M2026-06-05
16980077680200AOK20190039-013-H-S2026-06-05
16980077680149AOK20190039-013-XL2026-06-04
16980077680156AOK20190039-013-M2026-06-04
16980077680163AOK20190039-013-S2026-06-04
16980077680101AOK20200049-M2026-06-03
16980077680118AOK20200049-S2026-06-03
16980077680125AOK20200049-M2026-06-03
16980077680132AOK20200049-S2026-06-03
16980077680071AOK20190039-013-XL2026-05-28
16980077680088AOK20190039-013-M2026-05-28
16980077680095AOK20190039-013-S2026-05-28
16980077680057AOK20190039-013-L2026-05-12
16980077680064AOK20200049-L2026-05-12

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