FDA.reportPublic FDA data

NITRILE EXAM GLOVES-Blue-200pcs-L

Primary DI
90850047202164
Brand
NITRILE EXAM GLOVES-Blue-200pcs-L
Company
MEDTECS (TAIWAN) CORP.
Model
Blue-200pcs-L
Published
2023-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047202161PrimaryGS10
90850047202164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047202161008500472021618500472021610850047202161
9085004720216490850047202164

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
658023890
Device count
200
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850047202161NITRILE EXAM GLOVES-Blue-200pcs-LBlue-200pcs-L2023-06-17
00850047202178NITRILE EXAM GLOVES-Blue-200pcs-MBlue-200pcs-M2023-06-17
00850047202185NITRILE EXAM GLOVES-Blue-200pcs-SBlue-200pcs-S2023-06-17
00850047202192NITRILE EXAM GLOVES-Blue-200pcs-XSBlue-200pcs-XS2023-06-17
00850047202208NITRILE EXAM GLOVES-Cool Blue-200pcs-XLCool Blue-200pcs-XL2023-06-17
00850047202215NITRILE EXAM GLOVES-Cool Blue-200pcs-LCool Blue-200pcs-L2023-06-17
00850047202239NITRILE EXAM GLOVES-Cool Blue-200pcs-SCool Blue-200pcs-S2023-06-17
00850047202277NITRILE EXAM GLOVES-Black-200pcs-MBlack-200pcs-M2023-06-17
00850047202284NITRILE EXAM GLOVES-Black-200pcs-SBlack-200pcs-S2023-06-17
00850047202154NITRILE EXAM GLOVES-Blue-200pcs-XLBlue-200pcs-XL2023-06-17
04710415363480Isolation Gown High Risk With TapeIL-4036YKTP2023-12-18
00850047202505NITRILE EXAM GLOVES-Black-100pcs-XLBlack-100pcs-XL2023-11-08
00850047202512NITRILE EXAM GLOVES-Black-100pcs-LBlack-100pcs-L2023-11-08
00850047202529NITRILE EXAM GLOVES-Black-100pcs-MBlack-100pcs-M2023-11-08
00850047202536NITRILE EXAM GLOVES-Black-100pcs-SBlack-100pcs-S2023-11-08
00850047202543NITRILE EXAM GLOVES-Black-100pcs-XSBlack-100pcs-XS2023-11-08
00850047202222NITRILE EXAM GLOVES-Cool Blue-200pcs-MCool Blue-200pcs-M2023-06-17
00850047202246NITRILE EXAM GLOVES-Cool Blue-200pcs-XSCool Blue-200pcs-XS2023-06-17
00850047202253NITRILE EXAM GLOVES-Black-200pcs-XLBlack-200pcs-XL2023-06-17
00850047202260NITRILE EXAM GLOVES-Black-200pcs-LBlack-200pcs-L2023-06-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00850069531256AnthemMaxter Healthcare IncorporatedLZC2026-06-28
00850069531263AnthemMaxter Healthcare IncorporatedLZC2026-06-28
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00850069531287AnthemMaxter Healthcare IncorporatedLZC2026-06-28
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