Catalog Number

-

Brand Name

ASAP

Version/Model Number

20302

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

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

4f9e160a-18a0-4df2-90c8-9ff42bb48029

Public Version Date

June 21, 2022

Public Version Number

4

DI Record Publish Date

June 17, 2020

Package DI Number

20817508022564

Quantity per Package

10

Contains DI Package

10817508022567

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case