FDA.reportPublic FDA data

MEDHANDLER

Primary DI
00763256035164
Brand
MEDHANDLER
Company
Foodhandler Inc.
Model
39450312
Catalog number
39450312
Device description
MEDHANDLER NITRILE PF LRG COBALT BLUE 10/200
Published
2024-06-12
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763256035161PackageGS110In Commercial Distribution
00763256035164PrimaryGS10
20763256035168Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076325603516110763256035161
00763256035164007632560351647632560351640763256035164
2076325603516820763256035168

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
053169587
Device count
200
Lot or batch
true
Manufacturing date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00763256033122MEDHANDLER39458965394589652024-06-20
00763256033160MEDHANDLER39458966394589662024-06-20
00763256033184MEDHANDLER39458967394589672024-06-20
00763256089648MEDHANDLER39458964394589642024-06-20
00763256111127MEDHANDLER39450112394501122024-06-12
00763256111141MEDHANDLER39450114394501142024-06-12
00763256111165MEDHANDLER39450116394501162024-06-12
00763256111189MEDHANDLER39457335394573352024-06-12
00763256021129MEDHANDLER39454722394547222024-06-20
00763256021143MEDHANDLER39454724394547242024-06-20
00763256021167MEDHANDLER39454726394547262024-06-20
00763256021181MEDHANDLER39457331394573312024-06-20
10763256021126MEDHANDLER39454722394547222024-06-20
10763256021140MEDHANDLER39454724394547242024-06-20
10763256021164MEDHANDLER39454726394547262024-06-20
10763256021188MEDHANDLER39457331394573312024-06-20
10763256033143MEDHANDLER39458965394589652024-06-20
10763256033167MEDHANDLER39458966394589662024-06-20
10763256033181MEDHANDLER39458967394589672024-06-20
10763256033129MEDHANDLER39458964394589642024-06-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
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