Catalog Number

GLV-CB-M

Brand Name

Cool Blue™ Nitrile Gloves

Version/Model Number

GLV-CB-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

K202003,K202003

Product Code

FMC

Product Code Name

Patient Examination Glove

Public Device Record Key

d15084c1-63f1-45ba-b484-15d691703239

Public Version Date

August 10, 2022

Public Version Number

1

DI Record Publish Date

August 02, 2022

Package DI Number

10860008768244

Quantity per Package

10

Contains DI Package

00860008768247

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case