Catalog Number

SPK-SPFP

Brand Name

Sempermed Supreme Latex Surgical Glove

Version/Model Number

SPK-SPFP

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)

Yes

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

KGO

Product Code Name

Surgeon'S Gloves

Public Device Record Key

00794d34-ae9a-48bd-a565-cdd8271a0e12

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 01, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-