Catalog Number

62870-00

Brand Name

Kimtech Element Nitrile Exam Gloves (XS)

Version/Model Number

62870

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

K152720,K152720,K152720

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

1c16456e-0f40-420b-ae81-31c591335dbc

Public Version Date

July 22, 2021

Public Version Number

1

DI Record Publish Date

July 14, 2021

Package DI Number

10036000628705

Quantity per Package

10

Contains DI Package

00036000628708

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case