Catalog Number

5788005

Brand Name

ENCORE

Version/Model Number

5788005

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

f282e17b-483e-479c-8d5c-a88e22672f45

Public Version Date

February 04, 2022

Public Version Number

1

DI Record Publish Date

January 27, 2022

Package DI Number

20884792308858

Quantity per Package

50

Contains DI Package

00884792308854

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser