ANTIVIRAL BIOMASKTM

Executive Summary
[Adapted from the report by MAHARITA AB RAHMAN]

Review Group Membership Introduction

MaHTAS Reviewer:
Medical face mask is defined as a mask used for medical purposes especially to
Pn Maharita AB Rahman protect airway from any contamination.

Datin Dr Rugayah Bakri Today, the used of face mask is crucial after the outbreak of air borne diseases
such as influenza H1N1. For this reason, various types of face mask are
Dr. Junainah Sabirin
introduced in Malaysia. Following the outbreak of H1N1, the shape and type of
face mask is changed accordingly. Based on this, a new generation of face mask
TM
is introduced by Filligent Limited Company known as Antiviral Biomask .
External Reviewer:
None
This technology review was requested by Senior Principle Assistant Director of
Medical Resource Unit following the proposal from Pharmaniaga Sdn. Bhd. to
Disclaimer: introduce the usage of Antiviral BiomaskTM in Ministry of Health facilities.
Technology review is a brief
report, prepared on an urgent Objective/Aim
basis, which draws on restricted
reviews from analysis of pertinent
literature, on expert opinion and / The objective of this technology review was to assess the safety, efficacy or
TM
or regulatory status where effectiveness and cost-effectiveness of Antiviral Biomask .
appropriate. It is subjected to an
external review process. While Results and Conclusions
effort has been made to do so, this
document may not fully reflect all
scientific research available.
The search strategies did not yield any article regarding the safety, efficacy or
TM
Additionally, other relevant effectiveness and cost-effectiveness of Antiviral Biomask . The only source of the
scientific findings may have been studies was from the company itself. However, evidence on its efficacy and safety
reported since completion of this were laboratory studies. Clinical researches on human beings and in clinical
review. setting are warranted.
For further information please
contact:
Methods
Health Technology Assessment
Section (MaHTAS) Electronic databases were searched, which included PubMed, Ovid Medline (R)
Medical Development Division from 1990-2006 (EBM Reviews – Cochcrane Databases of Systematic Reviews),
Ministry of Health Malaysia National Horizon Scanning, INAHTA and FDA website, for published reports.
Level 4, Block E1, Precinct 1
Government Office Complex There was no limit in the search. Additional articles were identified from reviewing
62590 Putrajaya. the bibliographies of retrieved articles.

Tel: 603 8883 1246

Fax: 603 8883 1230

Available at the following website:

http://www.moh.gov.my

2010

Executive Summary
 ANTIVIRAL BIOMASK TM
Executive Summary
[Adapted from the report update by MAHARITA AB RAHMAN]

Review Group Membership UPDATE

MaHTAS Reviewer:
Addendum 24th AUGUST 2011
Pn Maharita AB Rahman
Datin Dr Rugayah Bakri Malaysia Health Technology Assessment (MaHTAS) Unit received new
TM
information on the Antiviral Biomask from the manufacturer / distributor.
Herewith is the updated information about this medical device.
External Reviewer:
None
SAFETY

Through the search in the United State Food and Drug Administration (USFDA)
website, it was found that, on 26 Mei 2011, USFDA gave 510(K) clearance to the
Disclaimer: TM
Technology review is a brief
Biofriend Biomask Surgical Facemask, Models Universal BF-200-2001 and
report, prepared on an urgent Premium BF-200-3013 Filligent Limited with 510(K) number K101128.
basis, which draws on restricted
reviews from analysis of pertinent EFFICACY/EFFECTIVENESS
literature, on expert opinion and /
or regulatory status where
appropriate. It is subjected to an No new evidence was found from the evidence search in the available scientific
external review process. While databases in MaHTAS.
effort has been made to do so, this
document may not fully reflect all CONCLUSION
scientific research available.
Additionally, other relevant
scientific findings may have been There was no new clinical evidence on the efficacy/effectiveness, and cost-
TM
reported since completion of this effectiveness of Antiviral Biomask . However, it has received the 510(k)
review. clearance from the USFDA.
For further information please
contact:

Health Technology Assessment

Section (MaHTAS)
Medical Development Division
Ministry of Health Malaysia
Level 4, Block E1, Precinct 1
Government Office Complex
62590 Putrajaya.

Tel: 603 8883 1246

Fax: 603 8883 1230

Available at the following website:

http://www.moh.gov.my

2011

Executive Summary