FDA.reportPublic FDA data

SAFETY MAX GOLD

Primary DI
00850048332447
Brand
SAFETY MAX GOLD
Company
Pristine Dental Supplies, Inc.
Model
SMN-45-M
Device description
MEDIUM Nitrile Medical Examination Gloves, Latex free, 4.5MIL 100 pieces per box 10 boxes per case 1000 pieces per case
Published
2023-03-18
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZAPolymer Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202384000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202384000Palm Care Blue Nitrile Examination Gloves Powder FreeHi-Care Thai Gloves Co. , Ltd.2020-12-02LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850048332447PrimaryGS10
00850048332034Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850048332447008500483324478500483324470850048332447
00850048332034008500483320348500483320340850048332034

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, 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; it includes an antimicrobial or antiviral agent/properties to reduce viable-microbe transmission/exposure and its inner surface is not covered with powder. 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/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. 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
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
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

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Primary DI, Brand, Company table
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