Catalog Number

48801

Brand Name

Halyard

Version/Model Number

48801

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"

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

K220541,K220541,K220541

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

bf1a9cc5-7e64-4e88-ac0c-9647c39cf37b

Public Version Date

June 14, 2022

Public Version Number

1

DI Record Publish Date

June 06, 2022

Package DI Number

30680651488016

Quantity per Package

10

Contains DI Package

20680651488019

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS