Catalog Number

-

Brand Name

Uline 5 Mil Latex Exam Gloves-L

Version/Model Number

S-9642L

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

Yes

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

Yes

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K001280,K001280,K001280

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

5fb4cf6e-1e5f-46af-bd55-676566d4764f

Public Version Date

October 27, 2020

Public Version Number

1

DI Record Publish Date

October 19, 2020

Package DI Number

30850015055028

Quantity per Package

10

Contains DI Package

10850015055024

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-