Catalog Number

SPK-SSNF

Brand Name

SemperShield Nitrile Exam Glove

Version/Model Number

SPK-SSNF

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

OPJ

Product Code Name

Medical Gloves With Chemotherapy Labeling Claims - Test For Use With Chemotherapy Drugs

Public Device Record Key

063039c7-c128-4466-9ff7-b4a1742604a0

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

-