FDA.reportPublic FDA data

ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XL

Primary DI
30850015055592
Brand
ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XL
Company
ULINE, INC.
Model
S-12549X
Published
2025-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
30850015055592PackageGS110In Commercial Distribution
10850015055819PrimaryGS10
00850015055812Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001505559230850015055592
1085001505581910850015055819
00850015055812008500150558128500150558120850015055812

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
039612668
Device count
100
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850015055833ULINE BLACK EXAM NITRILE GLVS-LS-21081-L2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MS-21081-M2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SS-21081-S2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XS-21081-X2026-07-14
10850015055871TOUGHGRIP 7 MIL LATEX GLOVES-LS-19177L2026-07-14
10850015055888TOUGHGRIP 7 MIL LATEX GLOVES-MS-19177M2026-07-14
10850015055895TOUGHGRIP 7 MIL LATEX GLOVES-SS-19177S2026-07-14
10850015055901TOUGHGRIP 7 MIL LATEX GLOVES-XS-19177X2026-07-14
10850015055918EXT CUFF 12 MIL LATEX GLOVES-LS-17904L2026-07-10
10850015055925EXT CUFF 12 MIL LATEX GLOVES-MS-17904M2026-07-10
10850015055932EXT CUFF 12 MIL LATEX GLOVES-SS-17904S2026-07-10
10850015055949EXT CUFF 12 MIL LATEX GLOVES-XS-17904X2026-07-10
10851253007622Uline First Aid Kit - 100 PersonH-3319H-33192019-01-18
10851253007639Uline First Aid Kit - 250 PersonH-3795H-37952019-01-18
10850015055826Trauma KitH-99542026-04-06
10851253007691Uline Burn Kit - Single UseH-4172H-41722019-01-18
10850015055789ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
10850015055796ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
10850015055802ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
10850015055819ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850005229803NeulynxMedgluv Inc.LZA2026-07-17
00850005229810NeulynxMedgluv Inc.LZA2026-07-17
00850005229827NeulynxMedgluv Inc.LZA2026-07-17
00850005229834NeulynxMedgluv Inc.LZA2026-07-17
00850005229841NeulynxMedgluv Inc.LZA2026-07-17
10850015055833ULINE BLACK EXAM NITRILE GLVS-LULINE, INC.LZA2026-07-14
10850015055840ULINE BLACK EXAM NITRILE GLVS-MULINE, INC.LZA2026-07-14
10850015055857ULINE BLACK EXAM NITRILE GLVS-SULINE, INC.LZA2026-07-14
10850015055864ULINE BLACK EXAM NITRILE GLVS-XULINE, INC.LZA2026-07-14
10686864061950Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061967Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
10686864061974Ocean Pacific NeoNaturalAMD Medicom IncLZA2026-07-13
00196633795618Kirkland SignatureCostco Wholesale CorporationLZA2026-07-10
10697383979435GloveworksAMMEX CORPORATIONLZA2026-07-10
20697383979432GloveworksAMMEX CORPORATIONLZA2026-07-10
00810169610312NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610336NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610350NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610374NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810169610398NEXT-GENGenesee Scientific Holdings, LLCLZA2026-07-06
00810145952115NeuleafMedgluv Inc.LZA2026-06-30
00810145952122NeuleafMedgluv Inc.LZA2026-06-30
00810145952139NeuleafMedgluv Inc.LZA2026-06-30
00810145952146NeuleafMedgluv Inc.LZA2026-06-30
00810145952108NeuleafMedgluv Inc.LZA2026-06-29
00850005229568NeuflexMedgluv Inc.LZA2026-06-29
00850005229575NeuflexMedgluv Inc.LZA2026-06-29
00850005229582NeuflexMedgluv Inc.LZA2026-06-29
00850005229599NeuflexMedgluv Inc.LZA2026-06-29
00850005229605NeuflexMedgluv Inc.LZA2026-06-29