Catalog Number

50604-54

Brand Name

KIMTECH PURPLE NITRILE-XTRA EXAM GLOVES (XL)

Version/Model Number

50604

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 15, 2020

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

K113423,K113423,K113423

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

e0fb5386-764c-4a6a-8818-61c23c219bdc

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10036016506042

Quantity per Package

10

Contains DI Package

00036016506045

Package Discontinue Date

April 15, 2020

Package Status

Not in Commercial Distribution

Package Type

Case