L-101 L-101V L-103V L-1063D(白色) 要报价
Please see if your product meets these specifications
1.1 Medical device covering the mouth, nose and chin which provides a barrier to minimize the direct transmission of airborne infection in the health care setting.
1.2 To be worn in the proximity of patients with pulmonary tuberculosis.
1.3 A valid NIOSH approval certificate must be attached; the approved product must feature on
the NIOSH website.
2. Technical Specification
Availability of masks
In order to ensure that people with different facial features are afforded adequate protection, two
different types of masks are recommended.
Construction and Material
a) All materials used in the composition of a mask shall be free from latex and glass.
b) All materials used to be tested for bio-compatibility and skin irritation.
c) The mask shall consist of four layers of non-woven material with No Valve
d) The four layers of the respirator shall be ultrasonically bonded to a depth of 8mm.
e) The respirator must not to be glued stitched.
f) The inner layers to be constructed by using a “wet lay” process.
g) The respirator must provide a secure fit (blow-by free) around the mouth and nose.
h) Two securing bands to be latex free and constructed of a synthetic elastomeric material of nominal width
i) The length shall be such that the elastic fits comfortably around the head of the wearer.
j) The nose piece/clamp should be made of aluminium with a nominal width of 3mm.
k) The nose and mouth piece must be flexible and easily malleable to conform across bridge of nose.
l) The foam strip shall be a polyurethane foam strip of width 35mm and 1mm nominal thickness.
m) The mask must cater for all facial structures, shapes and sizes ( regular and small)
n) The mask must be able to be used under a full face shield
o) Filtration efficiency
Bacterial filtration (BFE) to be>95%@ 0.3 micron
Particle filtration (PFE) to be >95%@ 0.1 micron
Fluid resistance should be at 160mm Hg
The packaging must be 50 masks per box, any amendments thereto will invalidate the
I am looking at ordering 20 000 pcs