Masks with Unique Patented 3-D Design
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 1
All tests were conducted in accordance with ISO 9001:2015 Standards.
NOTE 2
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.
TECHNICAL DATA SHEET Senior S95
ISO 9001:2015 / Senior Mask Non-Sterile with Patented 3-D DESIGN
Pasture Senior S95 Mask for Elderly
Material Description
| Filter Layers | 4 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 with blue print |
Bacterial Filtration Efficiency (BFE): ≥ 99.76% 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
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 S95 filtering face-piece mask has been manufactured for Pasture Pharma Pte Ltd
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture Senior S95 Mask is designed with understanding of breathing capacity of the elderly in mind, providing adequate protection and lower breathing resistance. It is indicated to be used by elderly patients to help protect the patient from the transfer of microorganisms and particulate material; by elderly 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 1
All tests were conducted in accordance with ISO 9001:2015 Standards.
NOTE 2
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.
TECHNICAL DATA SHEET 60S
US FDA 510K Approved Surgical Mask Non-Sterile with 3-D DESIGN
Pasture 60S Surgical Mask
Material Description
| Filter Layers: | 4 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: | Light Blue |
FDA 510(k):K141875
US FDA APROVAL Class II
FDA Classification Panel: General and Plastic Surgery
Bacterial Filtration Efficiency (BFE): ≥ 99.76% 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
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 – this model Pasture 60S filtering face-piece surgical mask is manufactured for Pasture Pharma Pte Ltd
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture 60S Surgical Mask is a US FDA approved surgical mask that is indicated to be used by the healthcare personnel during procedures to protect both the patient and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.
NOTE 1
All tests were conducted in accordance with US FDA Standards.
NOTE 2
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.