FDA.reportPublic FDA data

ForPro

Primary DI
00672047000895
Brand
ForPro
Company
Tng Worldwide, Inc.
Model
140739
Device description
Black Nitrile Exam GloveSize Large100ct
Published
2023-01-13
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
LZAPolymer Patient Examination Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110981000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110981000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00672047000901PackageGS110In Commercial Distribution
00672047000895PrimaryGS10
67204700089500Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00672047000901006720470009016720470009010672047000901
00672047000895006720470008956720470008950672047000895
6720470008950067204700089500

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-antimicrobialA device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers during patient examination/treatment or for other sanitary purposes; its inner surface is not covered with powder and it does not include antimicrobial agents/materials. The device is used mainly as a two-way barrier to protect patient/staff against contaminants and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide appropriate physical properties (e.g., tensile strength, resistance to puncture, elasticity), and uniformity of dimensions (i.e., sizing consistency). This is a single-use device.

Regulatory Flags#

DUNS number
155283302
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00672047004619ForPro1407922026-03-26
00672047004633ForPro1407942026-03-26
00672047004657ForPro1407962026-03-26
00672047004671ForPro1407982026-03-26
00672047001274ForPro1407512023-05-18
00672047001281ForPro1407522023-05-18
00672047001298ForPro1407532023-05-18
00672047001304ForPro1407502023-05-18
10672047001271ForPro1407512023-05-18
10672047001288ForPro1407522023-05-18
10672047001295ForPro1407532023-05-18
10672047001301ForPro1407502023-05-18
00672047000130ForPro1407252022-11-10
00672047000147ForPro1407262022-11-10
00672047000154ForPro1407272022-11-10
00672047000161ForPro1407282022-11-10
00672047000857ForPro1407372023-01-13
00672047000871ForPro1407382023-01-13
00672047000918ForPro1407402023-01-13
00672047000932ForPro1407412023-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810141933931VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933962VIVIT SupplyVivit Supply LLCLZA2026-10-07
10810141933979VIVIT SupplyVivit Supply LLCLZA2026-10-07
00850054870544BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870551BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870568BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870575BAYLAB USABaylab USA, LLCLZA2026-10-01
00850054870582BAYLAB USABaylab USA, LLCLZA2026-10-01
00662956201063Body Guard[Fastenal CompanyLZA2026-09-30
00662956201285Body Guard[Fastenal CompanyLZA2026-09-30
00662956202558Body GuardFastenal CompanyLZA2026-09-30
00662956203258Body GuardFastenal CompanyLZA2026-09-30
00662956203661BodyguardFastenal CompanyLZA2026-09-30
00662956203760BodyguardFastenal CompanyLZA2026-09-30
00662956205320Body GuardFastenal CompanyLZA2026-09-30
00662956210171Body GuardFastenal CompanyLZA2026-09-30
10860015093766MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093773MaadhoMaadho Distributors Inc.LZA2026-09-24
10860015093780MaadhoMaadho Distributors Inc.LZA2026-09-24
00199536900219BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZA2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZA2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZA2026-08-14