FDA.reportPublic FDA data

Safety Max Diamond

Primary DI
00850048332836
Brand
Safety Max Diamond
Company
Pristine Dental Supplies, Inc.
Model
SMD-35-M
Device description
MEDIUM 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
00850048332836PrimaryGS10
00850048332829Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048332836008500483328368500483328360850048332836
00850048332829008500483328298500483328290850048332829

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
00850048332867Safety Max DiamondSMD-35-L2023-03-30
00850048332898Safety Max DiamondSMD-35-XL2023-03-30
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
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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
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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
09001570536686Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536693Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536709Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536716Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536723Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536730Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536747Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
09001570536754Sempermed Syntegra GreenHarps USA, Inc.LZC2025-12-12
08994452290022Nitrile Examination Gloves Powder FreePT. SINTONG UNIGOLDEN GLOVELZC2024-02-26