FDA.reportPublic FDA data

Great Glove

Primary DI
B754SNM50020E0
Brand
Great Glove
Company
GD CARE INC.
Model
SNM50020E
Device description
Soft Nitrile Powder Free Medical Gloves Size Extra Large
Published
2023-04-03
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
B754SNM50020E1PackageHIBCC95In Commercial Distribution
B754SNM50020E2PackageHIBCC10In Commercial Distribution
B754SNM50020E0PrimaryHIBCC0

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
080925610
Device count
1
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B754CBK12515CareCBK12-5152022-09-29
B754ON50005CareON500052022-09-29
B754ON50010CareON500102022-09-29
B754ON50015CareON500152022-09-29
B754SBLKNM500E0Great GloveSBLK-NM500E2022-12-07
B754SBLKNM505E0Great GloveSBLK-NM505E2022-12-07
B754SBLKNM510E0Great GloveSBLK-NM510E2022-12-07
B754SBLKNM515E0Great GloveSBLK-NM515E2022-12-07
B754SBLKNM520E0Great GloveSBLK-NM520E2022-12-07
B754SNM50015E0Great GloveSNM50015E2023-04-03
B75470005Skintx700052022-09-29
B75470010Skintx700102022-09-29
B75470015Skintx700152022-09-29
B75470020Skintx700202022-09-29
B754NM50005E0Great GloveNM50005E2023-04-03
B754NM50010E0Great GloveNM50010E2023-04-03
B754NM50015E0Great GloveNM50015E2023-04-03
B754NM50020E0Great GloveNM50020E2023-04-03
B754NM50025E0Great GloveNM50025E2023-04-03
B754SNM50005E0Great GloveSNM50005E2023-04-03

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