FDA.reportPublic FDA data

Care

Primary DI
B754ON50015
Brand
Care
Company
GD CARE INC.
Model
ON50015
Device description
ON Nitrile Powder Free Medical Gloves Size Large
Published
2022-09-29
Public version status
Update
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
B754ON500151PackageHIBCC100Not in Commercial Distribution
B754ON500152PackageHIBCC10Not in Commercial Distribution
B754ON50015PrimaryHIBCC0

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
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
B754SNM50010E0Great GloveSNM50010E2023-04-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00194346693122EquateWAL-MART STORES, INC.LZA2026-06-02
00194346693139EquateWAL-MART STORES, INC.LZA2026-06-02
00768627017282Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
10840330702208ProCureTwin Med, LLCLZA2026-06-01
10840330702215ProCureTwin Med, LLCLZA2026-06-01
10840330702222ProCureTwin Med, LLCLZA2026-06-01
10840330702239ProCureTwin Med, LLCLZA2026-06-01
10840330702246ProCureTwin Med, LLCLZA2026-06-01
10840330706756ProCureTwin Med, LLCLZA2026-06-01
10840330706763ProCureTwin Med, LLCLZA2026-06-01
10840330706770ProCureTwin Med, LLCLZA2026-06-01
10840330706787ProCureTwin Med, LLCLZA2026-06-01
10840330706794ProCureTwin Med, LLCLZA2026-06-01
10860015093728MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093735MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093742MaadhoMaadho Distributors Inc.LZA2026-06-01
10860015093759MaadhoMaadho Distributors Inc.LZA2026-06-01
10840330702000ProCureTwin Med, LLCLZA2026-05-29
10840330702024ProCureTwin Med, LLCLZA2026-05-29
10840330702048ProCureTwin Med, LLCLZA2026-05-29
10840330702062ProCureTwin Med, LLCLZA2026-05-29
10840330702086ProCureTwin Med, LLCLZA2026-05-29
10840330702109ProCureTwin Med, LLCLZA2026-05-29
10840330702123ProCureTwin Med, LLCLZA2026-05-29
10840330702147ProCureTwin Med, LLCLZA2026-05-29
10840330702161ProCureTwin Med, LLCLZA2026-05-29
10840330702185ProCureTwin Med, LLCLZA2026-05-29