Catalog Number

-

Brand Name

CONDOR

Version/Model Number

2VLY2U

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

K110981,K110981,K110981

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

6bf1d66c-801b-4823-92fb-01aa880508de

Public Version Date

July 08, 2022

Public Version Number

1

DI Record Publish Date

June 30, 2022

Package DI Number

20194484320267

Quantity per Package

10

Contains DI Package

10194484320260

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Box