FDA.reportPublic FDA data

Dermatec White Nitrile

Primary DI
00813417020130
Brand
Dermatec White Nitrile
Company
Relda, Llc.
Model
GL+600WHITENBR
Catalog number
GL+600WHITENBR
Device description
Dermatec Pur-White Nitrile 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
LZAPolymer Patient Examination Glove

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10813417020137PackageGS110In Commercial Distribution
00813417020130PrimaryGS10
70813417020139Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081341702013710813417020137
00813417020130008134170201308134170201300813417020130
7081341702013970813417020139

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-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; 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 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.

Contacts#

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

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
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
00813417020574Dermatec VinylGL+600VINPFGL+600VINPF2022-09-05

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Primary DI, Brand, Company table
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00768627017299Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017305Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
00768627017312Norco Nitrile GlovesNORTH COAST MEDICAL, INC.LZA2026-06-01
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