FDA.reportPublic FDA data

GenaCheck Nitrile Exam Gloves

Primary DI
00810143620108
Brand
GenaCheck Nitrile Exam Gloves
Company
Genabio Diagnostics Inc.
Model
ZC8-E19700
Published
2023-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZAPolymer Patient Examination Glove
LZCMedical Glove, Specialty
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810143620108PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810143620108008101436201088101436201080810143620108

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
118586095
Device count
1
Premarket exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810143620221GenaCheck® Early Result Pregnancy TestN/A2025-02-26
00810143620115GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E197002025-01-13
00810143620139GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E198002025-01-13
00810143620146GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E199002025-01-13
00810143620153GenaCheck® Nitrile Powder Free Examination GloveN/AZC8-E201002025-01-13
00860008954800GenaCheck™ Fentanyl Urine Home-Use Test CassetteRA9-E02525RA9-E025012024-06-14
00810143620122GenaCheck® COVID-19 Rapid Self-Test 2TN/A2026-01-21
00810143620382GenaCheck® COVID-19 Rapid Self-Test 20TN/A2026-01-21
00810143620399GenaCheck® COVID-19 Rapid Self-Test 4TN/A2026-01-21
00810143620344GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024022025-05-19
00810143620368GenaCheck® COVID-19/Flu A&B Rapid Self-TestRA9-E024042025-05-19
00810143620214GenaCheck® FSH At-Home Menopause TestN/A2025-02-26
00810143620184Genabio COVID-19 Rapid Self-Test KitN/A2025-01-13
00810143620191GenaCheck®LH At-Home Ovulation Prediction TestN/A2025-01-13
00810143620207GenaCheck®PdG At-Home Ovulation Confirmation TestN/A2025-01-13
00860008954817GenaCheck®Fentanyl Urine Test CassetteN/ARA9-E025252025-01-13
00810143620009GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsRA9-E018022023-10-06
00810143620047GenaCheck Alcohol Rapid Self-Test KitRA9-E019052023-10-06
00810143620054GenaCheck 5-Drug Rapid Self-Test KitRA9-E021052023-10-06
00810143620061GenaCheck 12-Drug Rapid Self-Test KitRA9-E019022023-10-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10809160541722HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541746HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
10809160541753HalyardMEDICAL ACTION INDUSTRIES INC.LZC2026-10-26
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724312268568VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992639VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992646VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992653VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.QDO2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZC2026-10-23
00724351992660VitalAustin Pang Gloves Mfg (u.s.a.) Corp.LZA2026-10-23
00755676002529mvetADI MedicalLZA2026-10-23
00755676002550mvetADI MedicalLZA2026-10-23
00755676002581mvetADI MedicalLZA2026-10-23
00755676002611mvetADI MedicalLZA2026-10-23
00755676002765mvetADI MedicalLZA2026-10-23
00755676002796mvetADI MedicalLZA2026-10-23
00755676002826mvetADI MedicalLZA2026-10-23
00755676002857mvetADI MedicalLZA2026-10-23
00755676002994mvetADI MedicalLZA2026-10-23
00755676003021mvetADI MedicalLZA2026-10-23
00755676003052mvetADI MedicalLZA2026-10-23
00755676003083mvetADI MedicalLZA2026-10-23