Catalog Number

53101

Brand Name

Halyard

Version/Model Number

53101

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

K962139,K962139,K962139

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

48fa236c-8f89-4d05-944c-0e8e92e27583

Public Version Date

September 23, 2020

Public Version Number

1

DI Record Publish Date

September 15, 2020

Package DI Number

30680651531019

Quantity per Package

10

Contains DI Package

20680651531012

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS