FDA.reportPublic FDA data

Noble Products

Primary DI
00850045811082
Brand
Noble Products
Company
Clark Food Service Equipment
Model
394EN551SBOX
Device description
Nitrile Examination Gloves, Low Dermatitis Potential, 4 Mil, Powder-Free, Blue, Fingertip Textured, Small - 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
00850045811112PackageGS110In Commercial Distribution
00850045811082PrimaryGS10
10850045811089Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045811112008500458111128500458111120850045811112
00850045811082008500458110828500458110820850045811082
1085004581108910850045811089

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
00850045811099Noble Products394EN502MBOX2022-12-05
00850045811129Noble Products394EN552MBOX2022-12-05
00850045811143Noble Products394EN553LBOX2022-12-05
00850045811167Noble Products394EN554XLBOX2022-12-05
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
00199536900219BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900226BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900233BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900240BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900257BluelineTransparent Supply Solutions Ltd.LZC2026-09-18
00199536900820BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900837BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900844BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536900851BluelineTransparent Supply Solutions Ltd.LZC2026-08-14
00199536000018BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000025BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000032BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000049BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
00199536000056BluelineTransparent Supply Solutions Ltd.LZC2026-07-31
10304040195038CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195045CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195052CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195069CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195076CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195083CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195090CriterionHENRY SCHEIN, INC.LZC2026-07-29
10304040195106CriterionHENRY SCHEIN, INC.LZC2026-07-29
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