Catalog Number

-

Brand Name

Stretchease

Version/Model Number

1159G03-NI

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

K141590,K141590,K141590

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

6ed1fadc-b224-42af-9b0b-30395f62afe5

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 08, 2022

Package DI Number

10850015524001

Quantity per Package

10

Contains DI Package

00850015524004

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE