Catalog Number

-

Brand Name

Advance Plus ™ Latex Exam Gloves, Powder-Free

Version/Model Number

ADV2331

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

-

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

55dbda12-334b-4a50-8cea-ee115101b7ac

Public Version Date

October 05, 2020

Public Version Number

3

DI Record Publish Date

May 28, 2020

Package DI Number

00810012650144

Quantity per Package

10

Contains DI Package

00810012650106

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

case