Catalog Number

-

Brand Name

Firm Touch

Version/Model Number

6040BMD (2XL)

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

Product Code

FMC

Product Code Name

Patient Examination Glove

Public Device Record Key

b773cec6-7c58-43b2-9256-31c614388f1c

Public Version Date

August 08, 2022

Public Version Number

1

DI Record Publish Date

July 31, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-