Catalog Number

-

Brand Name

Medical Nitrile Examination Gloves (Power free, Blue)

Version/Model Number

XL

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"

Yes

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

K210578,K210578,K210578,K210578

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

556df44f-8e76-4e3e-ae9d-4ceae70bcd56

Public Version Date

September 08, 2021

Public Version Number

1

DI Record Publish Date

August 31, 2021

Package DI Number

26920756761902

Quantity per Package

10

Contains DI Package

16920756761905

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-