Catalog Number

-

Brand Name

GENERIC

Version/Model Number

VY001XS

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K173561,K173561,K173561

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

e90417f5-5b13-49c4-a71a-151a024b8d53

Public Version Date

August 28, 2019

Public Version Number

1

DI Record Publish Date

August 20, 2019

Package DI Number

00860002339627

Quantity per Package

10

Contains DI Package

00860002339603

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-