Catalog Number

3005

Brand Name

Strong Manufacturers

Version/Model Number

3005

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

-

Product Code

LYZ

Product Code Name

Vinyl Patient Examination Glove

Public Device Record Key

c56322fb-2de4-4708-927c-4bae8c3096e6

Public Version Date

March 30, 2022

Public Version Number

2

DI Record Publish Date

September 10, 2021

Package DI Number

10853927007099

Quantity per Package

1300

Contains DI Package

00853927007092

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case