Catalog Number

S-17904L

Brand Name

Ext Cuff 12 Mil Latex Gloves - L

Version/Model Number

S-17904L

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)

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

K962188,K962188,K962188

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

a2481fe6-398e-463a-b47b-fdbefb947388

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

December 12, 2018

Package DI Number

30851253007206

Quantity per Package

10

Contains DI Package

10851253007202

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-