FDA.reportPublic FDA data

Noble Products

Primary DI
00850045811068
Brand
Noble Products
Company
Clark Food Service Equipment
Model
394EN504XLBOX
Device description
Nitrile Examination Gloves, 4 Mil, Powder-Free, Blue, Fingertip Textured, X-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
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
00850045811075PackageGS110In Commercial Distribution
00850045811068PrimaryGS10
10850045811065Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850045811075008500458110758500458110750850045811075
00850045811068008500458110688500458110680850045811068
1085004581106510850045811065

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
00850045811082Noble Products394EN551SBOX2022-12-05
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00199536000018BluelineTransparent Supply Solutions Ltd.LZA2026-07-31
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