Catalog Number

-

Brand Name

Uline Wht 3 Mil Nitrile Glvs-M

Version/Model Number

S-21082-M

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

K170393,K170393,K170393

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

8330bab0-6720-4624-8b5d-8767e85d8661

Public Version Date

August 05, 2021

Public Version Number

1

DI Record Publish Date

July 28, 2021

Package DI Number

30850015055196

Quantity per Package

10

Contains DI Package

10850015055239

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-