Catalog Number

-

Brand Name

McKesson

Version/Model Number

14-660C

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

K172525,K172525,K172525

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

7784dd1b-b7fe-4364-8307-23042f5b0b9e

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

September 24, 2019

Package DI Number

00612479186316

Quantity per Package

10

Contains DI Package

00612479186309

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case