FDA.reportPublic FDA data

MH

Primary DI
00850018327503
Brand
MH
Company
Mazza Healthcare LLC
Model
60-460-MD
Device description
Nitrile Examination Gloves, 3.2 g, Low Dermatitis, Chemo Rated, Latex-Free, Powder-Free, Non-Sterile, Medium, 100/box
Published
2020-09-15
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
LZCPatient Examination 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
10850018327500PackageGS110In Commercial Distribution
00850018327503PrimaryGS10
20850018327507Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085001832750010850018327500
00850018327503008500183275038500183275030850018327503
2085001832750720850018327507

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
830069063
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850018327982MH7701BBNS2026-04-09
10850018327067MH14862020-09-15
10850018327074MH14962020-09-15
10850018327883MH02-610-MD2021-05-07
10850018327890MH02-615-LG2021-05-07
10850018327975MH97-0250-AT2024-10-25
00850018327008MH30152020-09-15
00850018327015MH60-205-SM2020-09-15
00850018327022MH60-210-MD2020-09-15
00850018327039MH60-215-LG2020-09-15
00850018327046MH60-220-XL2020-09-15
00850018327091MH30162020-09-15
00850018327107MH34-100-002020-09-15
00850018327114MH81-100-BK2020-09-15
00850018327121MH81-200-BK2020-09-15
00850018327138MH81-300-YW2020-09-15
00850018327145MHMH-4112022-12-09
00850018327152MH3006XL2020-11-15
00850018327169MH3006XXL2020-11-15
00850018327176MH30002020-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531195Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531195Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531201Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531218Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531225Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedQDO2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
00850069531249Maxter BlackMaxter Healthcare IncorporatedLZA2026-10-16
D184MYNTGNLG100BLK14MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNLG100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLK13MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNME100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNSM100PNK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLK1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXL100BLU1MYNTMynt ProfessionalLZA2026-10-16
D184MYNTGNXS100BLK1MYNTMynt ProfessionalLZA2026-10-16