Catalog Number

-

Brand Name

VGUARD

Version/Model Number

A19A35

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

K150340,K150340,K150340

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

11736cee-b739-4ba3-ae6a-79636b57c65d

Public Version Date

September 20, 2022

Public Version Number

1

DI Record Publish Date

September 12, 2022

Package DI Number

00810052975368

Quantity per Package

90

Contains DI Package

00810052975351

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box