Catalog Number

44-109M

Brand Name

NEXT-GEN

Version/Model Number

44-109M

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

700f35f4-e35c-40a2-95d2-66fd8053de19

Public Version Date

October 18, 2022

Public Version Number

2

DI Record Publish Date

August 18, 2022

Package DI Number

00850043811725

Quantity per Package

10

Contains DI Package

00850043811282

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-