Catalog Number

-

Brand Name

Firm Touch

Version/Model Number

6040BMD (M)

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"

-

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

Product Code

FMC

Product Code Name

Patient Examination Glove

Public Device Record Key

2e2541c9-5ab3-426e-8610-815f9f186062

Public Version Date

October 11, 2022

Public Version Number

2

DI Record Publish Date

July 31, 2022

Package DI Number

00810007198750

Quantity per Package

10

Contains DI Package

00810007198668

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case