N95 Respirators CONE-Shaped (Comfort Series)

N95 Respirators CONE-Shaped (Comfort Series)

TECHNICAL DATA SHEET PM 15 N95

US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile (Basic) with Ultrasonic Welding Head-Straps

Pasture PM 15/PM 15S (Small Size) Comfort Surgical N95 Respirator

Material Description
Filter Layers: 4 layers
Outer Layer: Polyester
Filter Media: Meltblown
Inner Layer: Polyester
Elastic Bands: Head-straps for secure seal
Nose-piece: Aluminum material
Nose-cushion: Foam
Color: White or Blue outer layer
US FDA APROVAL Class II / NIOSH APPROVAL: TC-84A-5411

Bacterial Filtration Efficiency (BFE): > 99% with 3.0μm, bio-aerosol particles

Particulate Filtration Efficiency (PFE): > 95% for particles at 0.3μm

Differential Pressure (DP): 10mm of H2O/cm2

Breathability (DP): Ezy-Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 85mm 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: Fit test required

Sizes: Two Sizes (Medium/Large and Small)

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: China, the model PM 15 filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-5411

Manufacturing Facilities: ISO 13485 / ISO 9001:2015

Indication for Use: Pasture PM 15, a NIOSH certified N95 respirator and FDA cleared surgical mask, is a disposable filtering face-piece indicated to be used by the healthcare personnel during procedures to protect both the patients and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material.

NOTE 1

An N95 designation indicates that the filtration is more than 95% (using NaCl particles with a diameter of 0.3μm). The masks are not resistant to oils, and do not filter out particles that came into contact with oils.

NOTE 2

All tests were conducted in accordance with US-FDA / NIOSH Standards.

NOTE 3

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 PM 16 N95

NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile (Foldable) with Nose Clip

Pasture PM 16/PM 16S (Small Size) Comfort N95 Respirator

Material Description
Filter Layers: 3 layers
Outer Layer: Polyproplylene
Filter Media: Meltblown
Inner Layer: Polyester
Elastic Bands: Head-straps for secure seal
Nose-piece: Aluminum material
Nose-cushion: High density urethane foam
Color: White
NIOSH APPROVAL: TC-84A-7867

Bacterial Filtration Efficiency (BFE): > 99% with 3.0μm, bio-aerosol particles

Particulate Filtration Efficiency (PFE): > 95% for particles at 0.3μm

Differential Pressure (DP): 10mm of H2O/cm2

Breathability (DP): Ezy-Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 85mm 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: Fit test required

Sizes: Two Sizes (Medium/Large and Small)

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: China, the model PM 16 filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-7867

Manufacturing Facilities: ISO 13485 / ISO 9001:2015

Indication for Use: Pasture PM 16, a NIOSH certified N95 respirator, is a disposable particulate filtering face-piece respirator designed to help provide reliable respiratory protection of at least 95% filtration efficiency against non-oil based particles such as those from grinding, sanding, sweeping, sawing, bagging, or other dusty operations.
It can also help reduce wearer exposure to certain pathogenic biological airborne particles but cannot eliminate the risk of contracting infection, illness or disease. Not designed for children.

NOTE 1

An N95 designation indicates that the filtration is more than 95% (using NaCl particles with a diameter of 0.3μm). The masks are not resistant to oils, and do not filter out particles that came into contact with oils.

NOTE 2

All tests were conducted in accordance with NIOSH Standards.

NOTE 3

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 PM 17 N95

NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Pre-Shaped Nose Area

Pasture PM 17 Comfort N95 Respirator

Material Description
Outer Layer: Polypropylene + Polyester
Filter Media: Meltblown
Inner Layer: Polyester
Elastic Bands: Adjustable loop style head-straps
Nose-piece: W/O
Nose-cushion: W/O
Color: White
NIOSH APPROVAL: TC-84A-4656

Bacterial Filtration Efficiency (BFE): > 99% with 3.0μm, bio-aerosol particles

Particulate Filtration Efficiency (PFE): > 95% for particles at 0.3μm

Differential Pressure (DP): 10mm of H2O/cm2

Breathability (DP): Ezy-Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 85mm 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: Fit test required

Size: One Size (Medium/Large)

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: China, the model PM 17 filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-4656

Manufacturing Facilities: ISO 13485 / ISO 9001:2015

Indication for Use: Pasture PM 17, a NIOSH certified N95 respirator, is a disposable particulate filtering face-piece respirator designed to help provide reliable respiratory protection of at least 95%
filtration efficiency against non-oil based particles such as those from grinding, sanding, sweeping, sawing, bagging, or other dusty operations.
It can also help reduce wearer exposure to certain pathogenic biological airborne particles but cannot eliminate the risk of contracting infection, illness or disease. Not designed for children.

NOTE 1

An N95 designation indicates that the filtration is more than 95% (using NaCl particles with a diameter of 0.3μm). The masks are not resistant to oils, and do not filter out particles that came into contact with oils.

NOTE 2

All tests were conducted in accordance with NIOSH Standards.

NOTE 3

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 PM 18 N95

NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Pre-Shaped Nose Area and Continuous Loop Headband

Pasture PM 18 Comfort N95 Respirator

Material Description
Filter Layers: 3 layers
Outer Layer: Polyester
Filter Media: Meltblown
Inner Layer: Polyester
Elastic Bands: Whole circle of woven tape, fully adjustable loop head-straps for secure fit
Nose-piece: W/O
Nose-cushion: W/O
Color: White
NIOSH APPROVAL: TC-84A-6806

Bacterial Filtration Efficiency (BFE): > 99% with 3.0μm, bio-aerosol particles

Particulate Filtration Efficiency (PFE): > 95% for particles at 0.3μm

Differential Pressure (DP): 10mm of H2O/cm2

Breathability (DP): Ezy-Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 85mm 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: Fit test required

Size: One Size (Medium/Large)

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: China, the model PM 18 filtering face-piece respirator has been manufactured for Pasture Pharma Pte. Ltd. under approval TC-84A-6806

Manufacturing Facilities: ISO 13485 / ISO 9001:2015

Indication for Use: Pasture PM 18, a NIOSH certified N95 respirator, is a disposable particulate filtering face-piece respirator designed to help provide reliable respiratory protection of at least 95% filtration efficiency against non-oil based particles such as those from grinding, sanding, sweeping, sawing, bagging, or other dusty operations.
It can also help reduce wearer exposure to certain pathogenic biological airborne particles but cannot eliminate the risk of contracting infection, illness or disease. Not designed for children.

NOTE 1

An N95 designation indicates that the filtration is more than 95% (using NaCl particles with a diameter of 0.3μm). The masks are not resistant to oils, and do not filter out particles that came into contact with oils.

NOTE 2

All tests were conducted in accordance with NIOSH Standards.

NOTE 3

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.