EXT Cuff 12 Mil Latex Gloves-S

Primary DI
30850015055080
Brand
EXT Cuff 12 Mil Latex Gloves-S
Company
ULINE, INC.
Model
S-17904S-S1
Device description
Sub Item Number
Published
2020-12-23
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

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LYYLatex Patient Examination GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123819000MULTIPLE NAMETop Calibre Sdn Bhd2013-03-05LYY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30850015055080PackageGS110In Commercial Distribution
10850015055123PrimaryGS10
00850015055126Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085001505508030850015055080
1085001505512310850015055123
00850015055126008500150551268500150551260850015055126

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.

Sterilization Methods#

Method table
Method

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
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
30850015055561ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, LARGES-12549L2025-04-28
30850015055578ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, MEDIUMS-12549M2025-04-28
30850015055585ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, SMALLS-12549S2025-04-28
30850015055592ULINE EXAM GRADE NITRILE GLOVES - POWDER-FREE, XLS-12549X2025-04-28
10850015055307Uline 25 Person First Aid Kit - SUBH-1293-S12022-01-14
10850015055314Uline 50 Person First Aid Kit - SUBH-1294-S12022-01-14
10850015055727ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
10850015055734ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
30850015055509ULINE REUSABLE EARPLUGS - UNCORDEDS-198732024-07-25
30850015055516ULINE REUSABLE EARPLUGS - CORDEDS-198742024-07-25
10850015055741ULINE BULLET EARPLUGS - UNCORDEDS-179022024-07-23
10850015055758ULINE BULLET EARPLUGS - CORDEDS-179032024-07-23
10850015055765ULINE BELL EARPLUGS - UNCORDEDS-221402024-07-23
10850015055772ULINE BELL EARPLUGS - CORDEDS-221412024-07-23

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