Catalog Number

43455

Brand Name

PremierPro Surgeons Glove

Version/Model Number

43455

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)

-

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

128cf1ff-264d-43ec-a23f-a2be3b71028a

Public Version Date

September 23, 2019

Public Version Number

2

DI Record Publish Date

January 14, 2019

Package DI Number

20811220030739

Quantity per Package

4

Contains DI Package

10811220030732

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE