Catalog Number

-

Brand Name

Techniglove International

Version/Model Number

RV405

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

-

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

57f48343-6a90-48d1-8d27-3f30ed5a0d2a

Public Version Date

June 19, 2020

Public Version Number

2

DI Record Publish Date

May 14, 2019

Package DI Number

00850008325151

Quantity per Package

10

Contains DI Package

00850008325052

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

inner box