FDA.reportPublic FDA data

Uline Safe-Flex 6 Mil Nitrile Glove - X

Primary DI
30851253007732
Brand
Uline Safe-Flex 6 Mil Nitrile Glove - X
Company
ULINE, INC.
Model
S-21573-X
Published
2019-10-01
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
QDOFentanyl And Other Opioid Protection Glove

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QDOFentanyl And Other Opioid Protection GloveGeneral Hospital1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183354000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183354000Powder Free Blue Nitrile Examination Gloves Tested for use with 32 Chemotherapy Drugs and Fentanyl CitrateGx Corporation Sdn Bhd2019-06-20LZA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
30851253007732PackageGS110In Commercial Distribution
10851253007738PrimaryGS10
00851253007731Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
3085125300773230851253007732
1085125300773810851253007738
00851253007731008512530077318512530077310851253007731

GMDN Terms#

Term, Definition table
TermDefinition
Nitrile examination/treatment glove, non-powdered, non-sterileA non-sterile 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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