Catalog Number

DYNJ81676

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ81676

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

KGO

Product Code Name

Surgeon's gloves

Public Device Record Key

b5b932cc-28af-4847-a6d8-171b9a1fe3df

Public Version Date

August 12, 2022

Public Version Number

1

DI Record Publish Date

August 04, 2022

Package DI Number

40195327132676

Quantity per Package

20

Contains DI Package

10195327132675

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE