Catalog Number

53131

Brand Name

Halyard

Version/Model Number

53131

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

K081027,K081027,K081027,K081027

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

be85d049-4d87-445c-acdd-980ddbd5d255

Public Version Date

November 23, 2020

Public Version Number

1

DI Record Publish Date

November 13, 2020

Package DI Number

30680651531316

Quantity per Package

4

Contains DI Package

20680651531319

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CS