Catalog Number

48364

Brand Name

Halyard

Version/Model Number

48364

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)

-

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K081260,K081260,K081260,K081260

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

172cf30b-9b90-40bd-a3be-0220484a6919

Public Version Date

April 25, 2022

Public Version Number

1

DI Record Publish Date

April 15, 2022

Package DI Number

20680651483649

Quantity per Package

4

Contains DI Package

10680651483642

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

DSP