Catalog Number

62863-00

Brand Name

Kimtech Opal Nitrile Exam Gloves (L)

Version/Model Number

62863

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

-

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

dcaf3e7e-1171-4de2-b75f-45069f647088

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

10036000628637

Quantity per Package

10

Contains DI Package

00036000628630

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case