Catalog Number

1024003

Brand Name

PureGuard

Version/Model Number

1024003

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"

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

K081592,K081592,K081592

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

7f5a9bee-5cdb-4952-b682-1c691eecbcdc

Public Version Date

April 02, 2021

Public Version Number

1

DI Record Publish Date

March 25, 2021

Package DI Number

D79010240033

Quantity per Package

1000

Contains DI Package

D79010240031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case