FDA.reportPublic FDA data

Safety Max Diamond

Primary DI
00850048332898
Brand
Safety Max Diamond
Company
Pristine Dental Supplies, Inc.
Model
SMD-35-XL
Device description
XLARGE Nitrile Medical Examination Gloves, Textured, Powder free, latex free, Violet Blue
Published
2023-03-30
Public version status
New
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
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
00850048332898PrimaryGS10
00850048332881Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048332898008500483328988500483328980850048332898
00850048332881008500483328818500483328810850048332881

GMDN Terms#

Term, Definition table
TermDefinition
Sterilization container linerA non-sterile device intended to be used to line containers used for steam or solvent sterilization (e.g., trays, wraps, pouches) to absorb moisture and protect the container's finish. It is typically made of an absorbent, non-woven material or paper. This is a single-use device.

Regulatory Flags#

DUNS number
080057154
Device count
100
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850048332799Safety Max DiamondSMD-35-XS2023-03-30
00850048332836Safety Max DiamondSMD-35-M2023-03-30
00850048332867Safety Max DiamondSMD-35-L2023-03-30
00850048332911Safety Max DiamondSMD-35-S2023-03-30
00850048332652Safety Max DiamondSMD-35-XS2023-03-30
00850048332829Safety Max DiamondSMD-35-M2023-03-30
00850048332850Safety Max DiamondSMD-35-L2023-03-30
00850048332881Safety Max DiamondSMD-35-XL2023-03-30
00850048332928Safety Max DiamondSMD-35-S2023-03-30
00850048332249Perfect SterilizationPFS-3.5-6.5 2023-03-18
00850048332287Perfect SterilizationPFS-7.5-13 2023-03-18
00850048332294Safety Max DiamondLIF-59-XS2023-03-18
00850048332355Safety Max DiamondLCIF-63-M2023-03-18
00850048332362Safety Max DiamondLCIF-63-L2023-03-18
00850048332379SAFETY MAX GOLDSMN-45-XL2023-03-18
00850048332447SAFETY MAX GOLDSMN-45-M2023-03-18
00850048332454SAFETY MAX GOLDSMN-45-S2023-03-18
00850048332461SAFETY MAX GOLDSMN-45-XS2023-03-18
00850048332485SAFETY MAX GOLDSMN-45-L2023-03-18
00850048332522Perfect SterilizationPFS-2.75-10 2023-03-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810145952115NeuleafMedgluv Inc.QDO2026-06-30
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.QDO2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.QDO2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.QDO2026-06-30