Catalog Number

-

Brand Name

True Comfort®

Version/Model Number

TC100XL

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

5dd43c0c-4082-42c7-9abb-3b2f725cf5de

Public Version Date

September 30, 2022

Public Version Number

1

DI Record Publish Date

September 22, 2022

Package DI Number

00649531766155

Quantity per Package

10

Contains DI Package

00649531766056

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case