FDA.reportPublic FDA data

Noble Products

Primary DI
00850045811167
Brand
Noble Products
Company
Clark Food Service Equipment
Model
394EN554XLBOX
Device description
Nitrile Examination Gloves, Low Dermatitis Potential, 4 Mil, Powder-Free, Blue, Fingertip Textured, Extra Large - Box of 100
Published
2022-12-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
LZCPatient Examination Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850045811174PackageGS110In Commercial Distribution
00850045811167PrimaryGS10
10850045811164Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045811174008500458111748500458111740850045811174
00850045811167008500458111678500458111670850045811167
1085004581116410850045811164

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
054146402
Device count
100

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850045811006Noble Products394EN501SBOX2022-12-05
00850045811068Noble Products394EN504XLBOX2022-12-05
00850045811082Noble Products394EN551SBOX2022-12-05
00850045811099Noble Products394EN502MBOX2022-12-05
00850045811129Noble Products394EN552MBOX2022-12-05
00850045811143Noble Products394EN553LBOX2022-12-05
00850045811181Noble Products394EN503LBOX2022-12-05
10850045811003Noble Products394EN501SBOX2022-12-05
10850045811065Noble Products394EN504XLBOX2022-12-05
00850045811112Noble Products394EN551SBOX2022-12-05
10850045811027Noble Products394EN502MBOX2022-12-05
00850045811136Noble Products394EN552MBOX2022-12-05
00850045811150Noble Products394EN553LBOX2022-12-05
00850045811174Noble Products394EN554XLBOX2022-12-05
00850045811198Noble Products394EN503LBOX2022-12-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZC2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZC2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZC2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZC2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LULINE, INC.LZC2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MULINE, INC.LZC2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SULINE, INC.LZC2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XULINE, INC.LZC2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZC2026-07-06
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00810145952436NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
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00810145952467NitraGrip Pro 100Medgluv Inc.LZC2026-06-30
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20680651500674HalyardO&M HALYARD, INC.LZC2026-06-04
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20680651500698HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500704HalyardO&M HALYARD, INC.LZC2026-06-04
20680651500711HalyardO&M HALYARD, INC.LZC2026-06-04
20680651502388HalyardO&M HALYARD, INC.LZC2026-06-04