FDA.reportPublic FDA data

EXT CUFF 12 MIL LATEX GLOVES-M

Primary DI
10850015055925
Brand
EXT CUFF 12 MIL LATEX GLOVES-M
Company
ULINE, INC.
Model
S-17904M
Published
2026-07-10
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
LYYLatex Patient Examination Glove
LZCMedical Glove, Specialty

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1
LZCMedical Glove, SpecialtyGeneral Hospital1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850015055691PackageGS110In Commercial Distribution
10850015055925PrimaryGS10
00850015055928Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001505569130850015055691
1085001505592510850015055925
00850015055928008500150559288500150559280850015055928

GMDN Terms#

Term, Definition table
TermDefinition
Hevea-latex examination/treatment glove, non-powdered, non-antimicrobialA device made of Hevea natural rubber latex (NRL) 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 both the patient and the staff against various contamination. It will have appropriate characteristics regarding tactility/comfort of use, and should provide appropriate physical properties (e.g., strength, elasticity), and uniformity of dimensions. This is a single-use device.

Regulatory Flags#

DUNS number
039612668
Device count
50
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
true
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10850015055321ANSI First Aid Kit Class B+, 250 PersonH-99972022-03-22
10851253007905ANSI First Aid Kit Class B+H-87572020-01-30
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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00850069531232Maxter BlackMaxter Healthcare IncorporatedLZC2026-10-16
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00199972000641CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000672CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000702CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000733CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00199972000764CuraplexBOUND TREE MEDICAL, LLCLZC2026-10-15
00850069531010Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531027Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531034Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531041Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531058Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531065Elevate BluMaxter Healthcare IncorporatedLZC2026-10-15
00850069531133Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531140Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531157Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531164Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531171Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
00850069531188Maxter BlueMaxter Healthcare IncorporatedLZC2026-10-15
10813172023848NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023855NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023862NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10813172023879NitriDerm® CSINNOVATIVE HEALTHCARE CORPORATIONLZC2026-10-09
10810141933931VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933948VIVIT SupplyVivit Supply LLCLZC2026-10-07
10810141933955VIVIT SupplyVivit Supply LLCLZC2026-10-07