Catalog Number

51944-00

Brand Name

Kimtech Prizm Neoprene Nitrile Exam Gloves (XL)

Version/Model Number

51944

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

5de0d473-dd6a-4daa-a1ec-0c9bbd6f8191

Public Version Date

January 07, 2021

Public Version Number

1

DI Record Publish Date

December 30, 2020

Package DI Number

10036000519447

Quantity per Package

10

Contains DI Package

00036000519440

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case