FDA.reportPublic FDA data

Dermatec Bronze Star

Primary DI
00813417020185
Brand
Dermatec Bronze Star
Company
Relda, Llc.
Model
GL600PFB
Catalog number
GL600PFB
Device description
Dermatec Bronze Star latex PF exam glove small 100/box, 10 box/case
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LYYLatex Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813417020182PackageGS110In Commercial Distribution
00813417020185PrimaryGS10
70813417020184Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081341702018210813417020182
00813417020185008134170201858134170201850813417020185
7081341702018470813417020184

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. 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.

Contacts#

Phone, Email table
PhoneEmail
(800) 992-8987rmoney@dermatec.net

Regulatory Flags#

DUNS number
101926900
Device count
100
Lot or batch
true
Contains natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00813417020123Dermatec White NitrileGL+500WHITENBRGL+500WHITENBR2022-09-05
00813417020130Dermatec White NitrileGL+600WHITENBRGL+600WHITENBR2022-09-05
00813417020147Dermatec White NitrileGL+601WHITENBRGL+601WHITENBR2022-09-05
00813417020154Dermatec White NitrileGL+602WHITENBRGL+602WHITENBR2022-09-05
00813417020161Dermatec White NitrileGL+603WHITENBRGL+603WHITENBR2022-09-05
00813417020178Dermatec Bronze StarGL500PFBGL500PFB2022-09-05
00813417020192Dermatec Bronze StarGL601PFBGL601PFB2022-09-05
00813417020208Dermatec Bronze StarGL602PFBGL602PFB2022-09-05
00813417020215Dermatec Bronze StarGL603PFBGL603PFB2022-09-05
00813417020239Dermatec Gold StarGL600PFGL600PF2022-09-05
00813417020246Dermatec Gold StarGL601PFGL601PF2022-09-05
00813417020253Dermatec Gold StarGL602PFGL602PF2022-09-05
00813417020260Dermatec Gold StarGL603PFGL603PF2022-09-05
00813417020376Dermatec Viper LatexGL+500BLACKPFGL+500BLACKPF2022-09-05
00813417020383Dermatec Viper LatexGL+600BLACKPFGL+600BLACKPF2022-09-05
00813417020390Dermatec Viper LatexGL+601BLACKPFGL+601BLACKPF2022-09-05
00813417020406Dermatec Viper LatexGL+602BLACKPFGL+602BLACKPF2022-09-05
00813417020413Dermatec Viper LatexGL+603BLACKPFGL+603BLACKPF2022-09-05
00813417020567Dermatec VinylGL+500VINPFGL+500VINPF2022-09-05
00813417020574Dermatec VinylGL+600VINPFGL+600VINPF2022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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10076490456556TOUCHNTUFFAnsell Healthcare ProductLYY2025-07-30
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09555002101077AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101084AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101091AURELIA VIBRANTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101404AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101411AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
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09555002101435AURELIA DISTINCTSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
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09555002101565AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101572AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101589AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
09555002101596AURELIA REFRESHSUPERMAX GLOVE MANUFACTURING SDN. BHD.LYY2024-02-08
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