Catalog Number

MTPM391M

Brand Name

Protective Pediatric Mitts

Version/Model Number

MTPM391M

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)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K110377

Product Code

FMQ

Product Code Name

Restraint, Protective

Public Device Record Key

d4de62a7-76ff-40ef-a3d3-ada2cc344f1c

Public Version Date

November 08, 2019

Public Version Number

2

DI Record Publish Date

July 23, 2019

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-