Catalog Number

-

Brand Name

Shamrock

Version/Model Number

30355/100

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

K052382,K052382

Product Code

LZA

Product Code Name

Polymer Patient Examination Glove

Public Device Record Key

9d52edb3-3386-4ee2-9bae-45f125f858d2

Public Version Date

May 18, 2021

Public Version Number

1

DI Record Publish Date

May 10, 2021

Package DI Number

10641932303554

Quantity per Package

10

Contains DI Package

00641932303557

Package Discontinue Date

-

Package Status

In Commercial Distribution

Package Type

CASE