FDA.reportPublic FDA data

Dermatec Vinyl

Primary DI
00813417020604
Brand
Dermatec Vinyl
Company
Relda, Llc.
Model
GL+603VINPF
Catalog number
GL+603VINPF
Device description
Dermatec Clear Vinyl PF exam glove large 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

Product Codes#

Code, Name table
CodeName
LYZVinyl Patient Examination Glove

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072227000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072227000VINYL EXAMINATION GLOVE POWDER FREEPinnacle Co., Ltd.2008-02-15LYZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813417020601PackageGS110In Commercial Distribution
00813417020604PrimaryGS10
70813417020603Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081341702060110813417020601
00813417020604008134170206048134170206040813417020604
7081341702060370813417020603

GMDN Terms#

Term, Definition table
TermDefinition
Vinyl examination/treatment glove, non-powderedA non-sterile device made of vinyl 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 talcum powder and it does not have antimicrobial features. 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
101926900
Device count
100
Lot or batch
true
No 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
00813417020185Dermatec Bronze StarGL600PFBGL600PFB2022-09-05
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

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Primary DI, Brand, Company table
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