Catalog Number

53130-54

Brand Name

KIMTECH STERLING NITRILE STERILE EXAM GLOVES, PAIRS (S)

Version/Model Number

53130

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

K081027,K081027,K081027

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

ca2c88ab-ed54-4dcb-8b47-da401fed948d

Public Version Date

May 12, 2020

Public Version Number

2

DI Record Publish Date

March 13, 2020

Package DI Number

20036000531309

Quantity per Package

4

Contains DI Package

10036000531302

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case