Catalog Number

-

Brand Name

CLEAN SAFETY

Version/Model Number

CS4901

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

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

c6bb88ed-1dbf-444e-add2-3c2c6727abd4

Public Version Date

August 05, 2022

Public Version Number

1

DI Record Publish Date

July 28, 2022

Package DI Number

00818420020689

Quantity per Package

10

Contains DI Package

00818420020443

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE