Catalog Number

-

Brand Name

Skintx

Version/Model Number

BLK90010

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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)

Yes

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

-

Product Code

LYY

Product Code Name

Latex Patient Examination Glove

Public Device Record Key

fb338cea-7195-4f29-b111-aa22ee259f75

Public Version Date

September 30, 2022

Public Version Number

3

DI Record Publish Date

April 18, 2022

Package DI Number

B754BLK900101

Quantity per Package

100

Contains DI Package

B754BLK90010

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Inner