Catalog Number

-

Brand Name

Uline Black Nitrile Glvs-XL

Version/Model Number

S-21081-X

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)

-

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

K132484,K132484,K132484

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

f504d93f-1442-4566-9929-de16b4786f8f

Public Version Date

August 25, 2020

Public Version Number

1

DI Record Publish Date

August 17, 2020

Package DI Number

30851253007992

Quantity per Package

10

Contains DI Package

10851253007998

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-