Catalog Number

-

Brand Name

Ext Cuff 12 Mil Latex Gloves-S

Version/Model Number

S-17904S

Device Commercial Distribution Status

Not in Commercial Distribution

Commercial Distribution End Date

April 29, 2020

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)

Yes

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

K982877,K982877,K982877

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

122bc384-bbd3-458a-bce7-8fc9c067168a

Public Version Date

June 19, 2020

Public Version Number

3

DI Record Publish Date

April 14, 2020

Package DI Number

30851253007947

Quantity per Package

10

Contains DI Package

10851253007943

Package Discontinue Date

April 29, 2020

Package Status

Not in Commercial Distribution

Package Type

-