FDA.reportPublic FDA data

Best Care

Primary DI
00655887141096
Brand
Best Care
Company
Meddcare Corporation
Model
BCGN447-L
Published
2022-08-29
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
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
00655887141096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00655887141096006558871410966558871410960655887141096

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile surgical glove, non-powderedA sterile device made of nitrile intended as a protective barrier when worn on the hands of healthcare providers at the surgical site; its inner surface is not covered with talcum powder and it does not have antimicrobial features. It is used mainly as a two-way barrier to protect patient and staff from microorganisms and risk of allergy to latex. It will have appropriate characteristics regarding tactility and comfort of use, and should provide adequate conditions of sterility, 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
108618903
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00655887141072Best CareBCGN447-S2022-08-29
00655887141089Best CareBCGN447-M2022-08-29
00655887141102Best CareBCGN447-XL2022-08-29
00655887141119Best CareBCGPV447-S2022-08-29
00655887141126Best CareBCGPV447-M2022-08-29
00655887141133Best CareBCGPV447-L2022-08-29
00655887141140Best CareBCGPV447-XL2022-08-29
00655887141157Best CareBCGN447-S2022-08-29
00655887141164Best CareBCGN447-M2022-08-29
00655887141171Best CareBCGN447-L2022-08-29
00655887141188Best CareBCGN447-XL2022-08-29
00655887141195Best CareBCGVEX447-S2022-08-29
00655887141201Best CareBCGVEX447-M2022-08-29
00655887141218Best CareBCGVEX447-L2022-08-29
00655887141225Best CareBCGVEX447-XL2022-08-29
00655887141232Best CareBCGVEX447-S2022-08-29
00655887141249Best CareBCGVEX447-M2022-08-29
00655887141256Best CareBCGVEX447-L2022-08-29
00655887141263Best CareBCGVEX447-XL2022-08-29

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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