Catalog Number

NG013M

Brand Name

CALICO

Version/Model Number

NG013M

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

K990186,K990186,K990186

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

14c02bed-4a0f-4912-af6d-469888077908

Public Version Date

August 25, 2022

Public Version Number

1

DI Record Publish Date

August 17, 2022

Package DI Number

20850044458190

Quantity per Package

10

Contains DI Package

00850044458196

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case