Catalog Number

DYNJ55045

Brand Name

Medline Industries, Inc.

Version/Model Number

DYNJ55045

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

K093726,K093726

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

582fa585-ec0f-4215-967a-cd97b5482749

Public Version Date

June 17, 2022

Public Version Number

5

DI Record Publish Date

August 28, 2018

Package DI Number

40889942529378

Quantity per Package

25

Contains DI Package

10889942529377

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE