Catalog Number

-

Brand Name

Vinyl PF

Version/Model Number

SPF100L

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

3a622317-1806-4e61-a71e-8a5c8674f122

Public Version Date

March 17, 2022

Public Version Number

2

DI Record Publish Date

July 31, 2021

Package DI Number

00649531241065

Quantity per Package

10

Contains DI Package

00649531210566

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case