Pasture Junior J95


TECHNICAL DATA SHEET Junior J95

ISO 9001:2015 / Junior Mask Non-Sterile with Patented 3-D DESIGN Pasture Junior J95 Mask for Children
Material Description
Filter Layers: 5 layers of non-woven fiber containing a filter web
Outer Layer: Polypropylene Thermobond
Filter Media: Polypropylene Meltblown
Inner Layer: Polypropylene and Polyethylene bi-component
Elastic Bands: Earloops, Synthetic elastic (no latex material)
Nose-piece: Combination of zinc wires and embedded polyethylene
Nose-cushion: None
Mask Style: Flat Pleated 3-D
Color: White
Bacterial Filtration Efficiency (BFE): > 99% with 3.0μm, bio-aerosol particles Particulate Filtration Efficiency (PFE): > 99% for particles at 0.1μm Differential Pressure (DP): 3.33mm H2O/cm2 Breathability (DP): Ezy-Breathe Technology Fluid Resistance: Resists Synthetic Blood @ 80mm Hg of pressure Textile Flammability: Class I – Normal Flame Spread Skin Irritation: No skin irritant Skin Sensitization: No skin sensitizer Cytotoxicity Test: Non-cytotoxic under conditions of study FIT ASSESSMENT TEST: No Fit Test Required Size: One Universal Size, fits majority of children (Ages 6 – 12) Storage: Store under cool, clean, and dry conditions. Avoid excessive heat (over 40°C or 104°F) Shelf Life: As a guide, 5 years from manufacture date Intended Use: Single Use Only Country of Origin: Singapore, Pasture Pharma Pte Ltd Country of Manufacture: Taiwan, the model J95 filtering face-piece junior mask has been manufactured for Pasture Pharma Pte Ltd Manufacturing Facilities: ISO 13485 / ISO 9001:2015 Indication for Use: Pasture Junior J95 Mask is indicated to be used by young patients to help protect the patient from the transfer of microorganisms and particulate material; by young patients with compromised immune system, requiring additional protection against pollution, germs, and allergens. The mask may be used as a disposable filtering face-piece in public health medical emergencies.
NOTE
  • All tests were conducted in accordance with ISO 9001:2015 Standards.
  • The mask covers from the upper part of the nose to below the chin; the mask protects against pollution, germs and allergens; the mask has no sharp edges and is free from burrs with smooth finish; the mask fibers are non-glass fibers; the mask is latex free.