Catalog Number

-

Brand Name

Protect U Guard Earloop Face Mask 3 Ply Green

Version/Model Number

P20033

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

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

K153409,K153409

Product Code

FXX

Product Code Name

Mask, Surgical

Public Device Record Key

f1940d7f-d1a0-409d-926a-49ca875fc915

Public Version Date

May 06, 2020

Public Version Number

4

DI Record Publish Date

February 24, 2017

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-