Catalog Number

RR170

Brand Name

Protech Proguard

Version/Model Number

RR170

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)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code

LZC

Product Code Name

Patient Examination Glove, Specialty

Public Device Record Key

f65061b1-d3f5-4ebc-b61b-269349301ccb

Public Version Date

April 09, 2018

Public Version Number

1

DI Record Publish Date

March 09, 2018

Package DI Number

08054301890763

Quantity per Package

5

Contains DI Package

08054301890022

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-