FDA.reportPublic FDA data

MEDHANDLER

Primary DI
00763256035126
Brand
MEDHANDLER
Company
Foodhandler Inc.
Model
39450310
Catalog number
39450310
Device description
MEDHANDLER NITRILE PF SML 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
10763256035123PackageGS110In Commercial Distribution
00763256035126PrimaryGS10
20763256035120Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076325603512310763256035123
00763256035126007632560351267632560351260763256035126
2076325603512020763256035120

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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