Catalog Number

93244100

Brand Name

MICROFLEX

Version/Model Number

93244100

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

0e973bb9-32c1-4f6e-8ef2-c588086866a1

Public Version Date

March 25, 2022

Public Version Number

1

DI Record Publish Date

March 17, 2022

Package DI Number

20076490613642

Quantity per Package

10

Contains DI Package

10076490613034

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

Case