Catalog Number

1028074

Brand Name

Safco Chloroprene Green

Version/Model Number

1028074

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

-

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

cf59a68e-0846-434b-b5f8-ea0bf05991c0

Public Version Date

August 20, 2018

Public Version Number

1

DI Record Publish Date

July 18, 2018

Package DI Number

D72310280741

Quantity per Package

3

Contains DI Package

D72310280743

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box