Catalog Number

50604-54

Brand Name

KIMTECH PURPLE NITRILE-XTRA EXAM GLOVES (XL)

Version/Model Number

50604

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

K162294,K162294,K162294

Product Code

LZC

Product Code Name

Patient examination glove, specialty

Public Device Record Key

24ec2cd9-f03d-4596-a56f-20923b38f15d

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

10036000506041

Quantity per Package

10

Contains DI Package

00036000506044

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case