Uline Black Exam Nitrile Glvs-L

Primary DI
30851253007961
Brand
Uline Black Exam Nitrile Glvs-L
Company
ULINE, INC.
Model
S-21081-L
Device description
Size Large Gloves
Published
2020-08-17
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132484000DERMAGRIP POWDER FREE BLACK NITRILE PATIENT EXAMINATION GLOVES, NON-STERILEWrp Asia Pacific Sdn. Bhd.2013-12-13LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30851253007961PackageGS110In Commercial Distribution
10851253007967PrimaryGS10
00851253007960Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085125300796130851253007961
1085125300796710851253007967
00851253007960008512530079608512530079600851253007960

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
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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Primary DI, Brand, Company table
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09551006060525NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060532NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060549NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060556NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060563NITRILECARE PREMIUMCAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060624NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060631NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060648NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060655NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060662NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006060822NITRILECARE PREMIUM CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061225NITRILECARE ELITECAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061249CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061256CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08
09551006061263CHLOROPRENE EXAMINATION PF CAREGLOVE GLOBAL SDN. BHD.LZA2024-03-08