Catalog Number

-

Brand Name

AdvanCare TM

Version/Model Number

RH21b 2021/08/31

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K170136,K170136,K170136

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

d32cbd40-0964-4c52-8fbe-bd303c0f0096

Public Version Date

November 01, 2022

Public Version Number

2

DI Record Publish Date

April 15, 2022

Package DI Number

B845ANBM100143

Quantity per Package

10

Contains DI Package

B845ANBM100141

Package Discontinue Date

December 31, 2027

Package Status

In Commercial Distribution

Package Type

AdvanCare