Catalog Number

-

Brand Name

Mckesson

Version/Model Number

14-1381

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K013554,K013554,K013554

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

78002387-e4ff-4cc7-b782-eb2637caa86d

Public Version Date

May 07, 2021

Public Version Number

2

DI Record Publish Date

August 04, 2020

Package DI Number

00612479188235

Quantity per Package

10

Contains DI Package

00612479188228

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case