Catalog Number

GL-N135FS

Brand Name

ProWorks

Version/Model Number

GL-N135FS

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

K081592,K081592,K081592

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

722be81e-413d-4556-b0d0-c0165d62dac2

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

April 20, 2020

Package DI Number

10075289145114

Quantity per Package

10

Contains DI Package

00075289145117

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

box