Catalog Number

RR165

Brand Name

Xguard

Version/Model Number

RR165

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

1c799012-f2aa-4a42-80bf-2185f9da97a8

Public Version Date

April 16, 2018

Public Version Number

1

DI Record Publish Date

March 16, 2018

Package DI Number

08054301890985

Quantity per Package

5

Contains DI Package

08054301890244

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

-