Catalog Number

SUNG205

Brand Name

SemperSure Green Nitrile Exam Glove

Version/Model Number

SUNG205

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

K183441,K183441

Product Code

OPJ

Product Code Name

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

Public Device Record Key

a8f6e045-5b0b-4a47-89da-b55cc91af759

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

January 17, 2020

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-