Catalog Number

SSEC105

Brand Name

SemperShield EC Nitrile Exam Glove

Version/Model Number

SSEC105

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

cc251c07-13bf-42b7-84b7-09d2193cd2f8

Public Version Date

April 18, 2022

Public Version Number

1

DI Record Publish Date

April 08, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-