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
16980077680262AOK20200049-H-M2026-06-24
16980077680255AOK20200049-H-L2026-06-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850086117037Resilient Medical SolutionsResilient Medical Solutions, LLCFXX2026-07-08
00840456202722JMUJMU DENTAL, INCFXX2026-07-07
00840456202739JMUJMU DENTAL, INCFXX2026-07-07
00840456202746JMUJMU DENTAL, INCFXX2026-07-07
00840456214619JMUJMU DENTAL, INCFXX2026-07-07
00840456214626JMUJMU DENTAL, INCFXX2026-07-07
00840456214633JMUJMU DENTAL, INCFXX2026-07-07
00840456214640JMUJMU DENTAL, INCFXX2026-07-07
00840456214657JMUJMU DENTAL, INCFXX2026-07-07
00850056441261Target Up&UpArmbrust Inc.FXX2026-06-25
00850056441254Target Up&UpArmbrust Inc.FXX2026-06-25
16980077680262AOKAOK TOOLING LIMITEDFXX2026-06-24
16980077680255AOKAOK TOOLING LIMITEDFXX2026-06-22
00842942008894PRIMEDpriMED Medical Products IncFXX2026-06-21
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