Catalog Number

5795000

Brand Name

ENCORE

Version/Model Number

5795000

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

1a768ba9-d37f-43ff-9b8d-73a2e04d6a95

Public Version Date

January 28, 2022

Public Version Number

5

DI Record Publish Date

July 22, 2021

Package DI Number

20884792209506

Quantity per Package

50

Contains DI Package

00884792209502

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Dispenser