Catalog Number

103C-M

Brand Name

Kashi Scientific

Version/Model Number

2201

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"

Yes

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

K003985,K003985,K003985

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

40b3433e-5058-46b6-a665-6c295799f83e

Public Version Date

February 07, 2022

Public Version Number

1

DI Record Publish Date

January 30, 2022

Package DI Number

00850039389092

Quantity per Package

10

Contains DI Package

00850039389085

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Carton