Catalog Number

GL-V104FM

Brand Name

ProWorks

Version/Model Number

GL-V104FM

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)

Yes

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K072227,K072227,K072227

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

e1eb7ecf-2a7a-483a-b3be-232939c3004a

Public Version Date

April 10, 2020

Public Version Number

1

DI Record Publish Date

April 02, 2020

Package DI Number

10075289132138

Quantity per Package

10

Contains DI Package

00075289132131

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box