Standard Specifications of Mask Manufactured by Alpha Arogya India Pvt. Limited


WHO – GMP World Health Organization - GMP
ISO 9001:2015 QMS - Quality Management System
ISO 13485:2012 MDQMS - Medical Devices Quality Management System
ISO 45001:2018    OHSMS - Occupational Health & Safety Management System
Product : Alpha Face Guard
Type : HSN-95 (Herbal Sanitized)
Purpose : Two Way Protection from Dust, Allergies and Pollution

Fabric : Poly propylene non-woven fabric – Virgin Grade
First Layer : 50 GSM White Color
Second Layer : 22 GSM White Color
Third Layer : 22 GSM White Color

Unfolded Width : 2250 mm
Unfolded Length : 1300 mm
Nose Clip Length   : 70 mm
Joints : Thread stitching for easy breathing
Type A : With Elastic Ear Loop
Type B : With 15 Inch PP Back Tie by four laces

These masks are intended to be worn by person to protect from transfer of micro-organism, dust particles and body fluids. It is latex and static free.

Questions & Answers :

Q. What are the common types of masks?
A. The common types of masks are Surgical Mask, Respirator and Cloth Mask.

Q. What is the difference between a mask and a respirator?
A. A face mask is a loose fitting mask that covers the nose and mouth area. They are designed to be used as One Way Protection only; capturing large particles or droplets from wearer and preventing them from being spread to the environment. They are typically used to prevent the spread of common cold and flu. Face mask DO NOT protect the wearer at all. They are only recommended as a precautionary measure to protect the people around you.
A respirator is a tight fitting mask that creates a Facial Seal, which will provide Two Way Protection filtering the air entering and exiting the wearer at a level of efficiency designated by the respirator. All respirators have two straps and metal nose piece. They provide a high degree of efficiency when worn properly.

Q. What do the ratings N, R or P over respirator indicate?
A. Respirators are rated 'N', if they are Not resistant to oil, 'R' if somewhat Resistant to oil, and 'P' if strongly resistant (oil proof).

Q. What are N-95, N-99, N-100, KN95, P2, KMOEL and DS? Please also explain EN149:1991 and EN149:2001.
A. These nomenclatures define the category - Minimum Filter Efficiency. N-95 (USA), KN95 (China), FFP2 (Europe), P2 (Australia), KMOEL (Korea) and DS (Japan) comes under the category of Minimum Filter Efficiency ≥ 95%. The other nomenclatures and their minimum filter efficiency are - N-99 ≥ 99%, N-100 ≥ 99.97%, FFP1 ≥ 80%, FFP3 ≥ 98%.
Under the preceding EN149:1991 standard, the classifications are FFP1S, FFP2S, FFP2SL, FFP3S and FFP3SL. EN149:2001 classify half masks into three types according to their filtering capacities (e.g., FFP1, FFP2, and FFP3).

Q. Who are the agencies which certify the mask standards?
A. NIOSH – National Institute for Occupational Safety and Health (Department of CDC, USA), Nelson Labs, US is a pre-certification testing agency, OSHA – Occupational Safety and Health Administration. (KN-95) China Government), FFP2 (Europe), P2 (Australia), KMOEL (Korea) and DS (Japan).

Q. Why do some N95 respirators have a breathing valve in the front?
A. The use of an exhalation valve reduces exhalation resistance, but it does not help with breathing in. Some users feel that a respirator with an exhalation valve keeps the face cooler and reduces moisture build up inside the facepiece.

Q. When is it advisable to use surgical masks?
A. Surgical mask is intended to be worn by health professionals during surgery and during nursing to catch the bacteria shed in liquid droplets and aerosols from the wearer's mouth and nose. They are not designed to protect the wearer from inhaling airborne bacteria or virus particles.
These are also popularly worn by the general public all year round in various East Asian countries to reduce the chance of spreading airborne diseases to others, and to prevent the breathing in of airborne dust particles created by air pollution.

Q. What is the filtration capacity of surgical masks?
A. It can vary between 10 - 90%, depending on manufacturers’ specifications.

Q. Can a surgical mask be reused?
A. Surgical masks are not intended to be used more than once.

Q. Can a respirator be reused?
A. A respirator is washable with extra care through light detergent.