NOVEL - CAZ fiber achieved FDA Class 1 and classified as OUK

CAZ has achieved FDA Class 1

 

Class 1

There may be concerns that copper could be harmful to the human body, but FDA approval has proven that this CAZ has no effect on the human body. 

As this VirusBuster filter uses CAZ fiber, it is also harmless to the human body. 

But, this filter has no FDA because filter does not come into contact with humans.

 

Listing Number

 

Product Code: OUK   (510K) - We will update when we got an approval certificate from the FDA.

FDA site link: Surgical Mask With Antimicrobial/Antiviral Agent

Product Classification

FDA OUK link: Product Classification

Search classified manufacturer: FDA Report

 

OUK Product Classification

Device	Surgical Mask With Antimicrobial/Antiviral Agent
Regulation Description	Surgical apparel.
Definition	A single use, disposable surgical mask for occupational use to cover the nose and mouth of the wearer to protect from the transfer of microorganisms,body fluids and particulates and has an added antimicrobial and/or antiviral agent which kills specific pathogens under specified contact conditions.
Physical State	The device is a surgical mask composed of at least 3 layers of filtration material with bands or ties to secure it to the head, a flexible noseband and an added, specified antimicrobial and/or antiviral agent added to the surgical mask
Technical Method	Device uses a combination multiple filtration layers to protect from the transfer of microorganisms, body fluids and particulates plus the addition of an antimicrobial and/or antiviral agent which kills specified pathogensunder specified contact conditions
Target Area	The device is worn over the nose and mouth and is intended to protect the respiratory tract from transfer of microorganisms, body fluids and particulates.
Regulation Medical Specialty	General & Plastic Surgery
Review Panel	General Hospital
Product Code	OUK
Premarket Review	Surgical and Infection Control Devices (OHT4) Infection Control and Plastic Surgery Devices (DHT4B)
Submission Type	510(k)
Regulation Number	878.4040
Device Class	2
Total Product Life Cycle (TPLC)	TPLC Product Code Report
GMP Exempt?	No
Summary Malfunction Reporting	Eligible
Implanted Device?	No
Life-Sustain/Support Device?	No
Third Party Review	Not Third Party Eligible