Catalog Number

-

Brand Name

Gymda

Version/Model Number

L

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)

Yes

Kit

-

Combination Product

-

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

-

FDA Premarket Submission

K212078

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

277bad6f-8106-49d8-8f85-77431cd33f86

Public Version Date

May 24, 2022

Public Version Number

1

DI Record Publish Date

May 16, 2022

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-