FDA.reportPublic FDA data

DUKES

Primary DI
09359332000419
Brand
DUKES
Company
Dukes International LLC
Model
BIOFLEXX
Device description
DUKES BIOFLEXX 3.5g Violet Powder Free Nitrile Examination Glove - Size M (100 count)
Published
2023-03-28
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
09359332000457PackageGS110In Commercial Distribution
09359332000419PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09359332000457093593320004579359332000457
09359332000419093593320004199359332000419

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.

Regulatory Flags#

DUNS number
046648137
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09359332000495DUKESBIOFLEXX2023-03-29
09359332000402DUKESBIOFLEXX2023-03-28
09359332000426DUKESBIOFLEXX2023-03-28
09359332000433DUKESBIOFLEXX2023-03-28
09359332000518DUKES BIOFLEXX2023-03-28
09359332000440DUKESBIOFLEXX2023-03-28
09359332000457DUKESBIOFLEXX2023-03-28
09359332000464DUKESBIOFLEXX2023-03-28
09359332000471DUKESBIOFLEXX2023-03-28
09359332000556DUKES BIOFLEXX2023-03-28
09359332000488DUKESBIOFLEXX2023-03-27
09359332000501DUKES BIOFLEXX2023-03-27
09359332000525DUKESBIOFLEXX2023-03-27
09359332000549DUKES BIOFLEXX2023-03-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810169610312NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCQDO2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
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00810194400148AiraAIRA, LLCLZA2026-01-16
00810194400193AiraAIRA, LLCLZA2026-01-16
00842942014154PRIMEDpriMED Medical Products IncLZA2025-11-18
00842942014154PRIMEDpriMED Medical Products IncLZC2025-11-18