Catalog Number

52816-54

Brand Name

KIMTECH LAVENDER NITRILE EXAM GLOVES (XS)

Version/Model Number

52816

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

K162146,K162146,K162146

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

b12d0650-6368-4cb9-b85a-fd048a70c1b1

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

March 23, 2020

Package DI Number

10036000528166

Quantity per Package

10

Contains DI Package

00036000528169

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case