Catalog Number

51943-00

Brand Name

Kimtech Prizm Neoprene Nitrile Exam Gloves (L)

Version/Model Number

51943

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

K202416,K202416,K202416

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

a69b2e69-4838-47bd-874d-61615bf39278

Public Version Date

January 07, 2021

Public Version Number

1

DI Record Publish Date

December 30, 2020

Package DI Number

10036000519430

Quantity per Package

10

Contains DI Package

00036000519433

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case