Catalog Number

62829-00

Brand Name

KIMTECH VISTA NITRILE EXAM (XL)

Version/Model Number

62829

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

8cb51e30-b816-466e-b18a-667dcdbbb5f9

Public Version Date

April 23, 2021

Public Version Number

1

DI Record Publish Date

April 15, 2021

Package DI Number

10036000628293

Quantity per Package

10

Contains DI Package

00036000628296

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case