Catalog Number

1067303

Brand Name

PureHorizon

Version/Model Number

1067303

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

K110960,K110960,K110960

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

61263d1b-8ee0-45ac-9a72-4339c49b786c

Public Version Date

April 05, 2021

Public Version Number

1

DI Record Publish Date

March 26, 2021

Package DI Number

D79010673033

Quantity per Package

2000

Contains DI Package

D79010673031

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case