FDA.reportPublic FDA data

ADI Medical

Primary DI
10755676001055
Brand
ADI Medical
Company
ADI Medical
Model
10351
Device description
Dynatouch Nitrile Exam Gloves - Powder-Free, Blue, Large
Published
2023-11-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20755676001052PackageGS110In Commercial Distribution
10755676001055PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2075567600105220755676001052
1075567600105510755676001055

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
607022126
Device count
1
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00843079104251Mvet000.30220.22025-07-14
00843079104268Mvet000.30222.22025-07-14
00843079104282Mvet000.30226.22025-07-14
20843079104255Mvet000.30220.22025-07-14
20843079104262Mvet000.30222.22025-07-14
00843079104275Mvet000.30224.22025-07-14
20843079104286Mvet000.30226.22025-07-14
00843079100017Mvet000.30002.22022-12-07
00843079100024Mvet000.30004.22022-12-07
00843079100031Mvet000.30006.22022-12-07
00843079100048Mvet000.30008.22022-12-07
00843079100000Mvet000.30000.22022-12-07
10755676000294ADI Medical123512023-11-28
10755676000300ADI Medical123412023-11-28
10755676000317ADI Medical123712023-11-28
10755676000324ADI Medical123612023-11-28
20755676000291ADI Medical123512023-11-28
20755676000307ADI Medical123412023-11-28
20755676000314ADI Medical123712023-11-28
20755676000321ADI Medical123612023-11-28

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
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00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
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00810145951972NeuPro 16Medgluv Inc.LZA2026-06-26
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00810145951996NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952009NeuPro 16Medgluv Inc.LZA2026-06-26
00810145952153NeulynxMedgluv Inc.LZA2026-06-26
10304040194048EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194055EssentialsHENRY SCHEIN, INC.LZA2026-06-25
10304040194062EssentialsHENRY SCHEIN, INC.LZA2026-06-25