Catalog Number

3273/ 8

Brand Name

Majestic

Version/Model Number

3273/ 8

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

c0bdad9b-46e0-4cb6-af01-863c5f7d64fe

Public Version Date

April 28, 2022

Public Version Number

1

DI Record Publish Date

April 20, 2022

Package DI Number

20731791034540

Quantity per Package

10

Contains DI Package

00731791034546

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE