Catalog Number

50580-53

Brand Name

KIMTECH BLUE NITRILE EXAM GLOVES (L)

Version/Model Number

50580

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

K163267,K163267,K163267

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

a2810db5-89e6-4b1a-8e50-f0930a7a1d46

Public Version Date

September 10, 2020

Public Version Number

3

DI Record Publish Date

March 13, 2020

Package DI Number

10036000505808

Quantity per Package

10

Contains DI Package

00036000505801

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case