FDA.reportPublic FDA data

MEDHANDLER

Primary DI
00763256033122
Brand
MEDHANDLER
Company
Foodhandler Inc.
Model
39458965
Catalog number
39458965
Device description
MedHandler Natural Stretch Vinyl Gloves PF MED 10/100
Published
2024-06-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10763256033143PackageGS110Not in Commercial Distribution
00763256033122PrimaryGS10
20763256033140Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1076325603314310763256033143
00763256033122007632560331227632560331220763256033122
2076325603314020763256033140

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
100
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
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
00763256005433MEDHANDLER39450543394505432024-06-12

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10840330705230ProCureTwin Med, LLCLYZ2026-05-27
20193489081562MEDLINEMEDLINE INDUSTRIES, INC.LYZ2026-02-11
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20197344098184SYNA MEDICALMEDLINE INDUSTRIES, INC.LYZ2024-09-27
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