Catalog Number

-

Brand Name

Get-A-Grip

Version/Model Number

79760PF-BKGR

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

K220373,K220373,K220373

Product Code

LZA

Product Code Name

Polymer patient examination glove

Public Device Record Key

9e09db22-f61c-4006-852e-fbe9d56eaf2b

Public Version Date

June 03, 2022

Public Version Number

1

DI Record Publish Date

May 26, 2022

Package DI Number

00150042054322

Quantity per Package

900

Contains DI Package

00850042054321

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CARTON