Masks with Unique Patented 3-D Design

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.