Catalog Number

43440-53

Brand Name

KIMTECH SPRING GREEN NITRILE POWDER FREE EXAM GLOVES (L)

Version/Model Number

43440

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

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

d23ec596-3e54-4f34-aa6a-6753604318ef

Public Version Date

November 15, 2021

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10036000434405

Quantity per Package

10

Contains DI Package

00036000434408

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case