Catalog Number

-

Brand Name

Uline 4 Mil Nitrile Exam Glvs-L

Version/Model Number

S-12549L

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

c1177ba9-ce72-44f0-bb2b-2078a0a5c03a

Public Version Date

May 03, 2021

Public Version Number

1

DI Record Publish Date

April 23, 2021

Package DI Number

30850015055141

Quantity per Package

10

Contains DI Package

10850015055185

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-