Catalog Number

SVF5C2

Brand Name

SafeHealth

Version/Model Number

SVF5C2

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

803951ef-68b9-4291-b846-a3d64c2d28a4

Public Version Date

October 31, 2022

Public Version Number

2

DI Record Publish Date

September 24, 2020

Package DI Number

04712832881554

Quantity per Package

1000

Contains DI Package

04712832881509

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case