FDA.reportPublic FDA data

NITRILE EXAM GLOVES-Blue-200pcs-S

Primary DI
00850047202185
Brand
NITRILE EXAM GLOVES-Blue-200pcs-S
Company
MEDTECS (TAIWAN) CORP.
Model
Blue-200pcs-S
Published
2023-06-17
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
LZCMedical Glove, Specialty
ODQHypothermia System, Acute Myocardial Infarction
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
ODQHypothermia System, Acute Myocardial Infarction
OPJMedical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy DrugsGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850047202185PrimaryGS10
90850047202188Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850047202185008500472021858500472021850850047202185
9085004720218890850047202188

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
658023890
Device count
200
Manufacturing date on label
true
No natural rubber latex
true

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
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
00850047202291NITRILE EXAM GLOVES-Black-200pcs-XSBlack-200pcs-XS2023-06-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09001570557278Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557308Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557339Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557360Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557391Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557421Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557452Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557483Sempermed Syntegra GreenHarps USA, Inc.LZC2026-05-21
09001570557797Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557827Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557858Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
09001570557889Sempermed Syntegra preCisionHarps USA, Inc.LZC2026-05-21
08859185202172mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202189mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202196mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202202mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185202219mCare Diamond OrangeMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209249Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209256Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209263Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209270Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209287Nitrylex classic blue chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209294Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209300Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209317Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209324Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
08859185209331Nitrylex black chemoMERCATOR MEDICAL (THAILAND) LIMITEDLZA2026-03-26
09001570557285Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557315Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12
09001570557346Sempermed Syntegra GreenHarps USA, Inc.LZC2026-02-12