N95 Respirators DUCKBILL Shaped

TECHNICAL DATA SHEET F550G

USFDA/NIOSH N95 Approved Respirator DUCKBILL Mask non-sterile with continuous loop headband

Pasture F550G

Material Description

US FDA APROVAL Class II / ISO 9001:2008 / NIOSH APPROVAL: N95 TC84A-4665

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

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

Differential Pressure (DP): 10 mm H2O/cm2

Breathability (DP): Ezy Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 160mmHg 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: Does not require fit test

Sizes: One Size, fits approx.90% of adult population

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 F550G filtering face-piece respirator has been manufactured for Pasture Pharma Pte. Ltd. under approval TC-84A-4665

Indication for use: Pasture F550G, certified N95 respirator, is a disposable filtering face-piece intended for use by the general public to help reduce wearer exposure to pathogenic biological airborne particulates in public health medical emergencies. 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 US-FDA / NIOSH and CDC / ISO 9001:2008 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 F550S

USFDA/NIOSH N95 Approved Respirator DUCKBILL Mask non-sterile with continuous loop headband

Pasture F550S

Material Description

US FDA APROVAL Class II / ISO 9001:2008 / NIOSH APPROVAL: N95 TC-84A-7504

FDA Classification panel: General and Plastic Surgery

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

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

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

Breathability (DP): Ezy Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 160mmHg 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: One Size, previous test results fit approx.90% of adult population

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 F550S filtering face-piece respirator has been manufactured for Pasture Pharma Pte. Ltd. under approval TC-84A-7504

Indication for use: Pasture F550S is a NIOSH certified N95 respirator, and is indicated to be used by 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 and CDC / ISO 9001:2008 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 F550CS

USFDA/NIOSH N95 Approved Respirator DUCKBILL Mask non-sterile with adjustable clip

Pasture F550CS Surgical N95 Respirator

Material Description

US FDA APROVAL Class II / ISO 9001:2008 / NIOSH APPROVAL: N95 TC-84A-7504

FDA Classification panel: General and Plastic Surgery

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

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

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

Breathability (DP): Ezy Breathe Technology

Fluid Resistance: Resists Synthetic Blood @ 160mmHg 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: One Size, previous test results fit 90% of population

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, F550CS filtering face-piece respirator has been manufactured for Pasture Pharma, Pte. Ltd. under approval TC-84A-7504

Indication for use: Pasture F550CS is a NIOSH certified N95 respirator, and is indicated to be used by healthcare personnel during procedures to protect both the patients and the healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. F550CS is the same respirator as the F550S, except F550CS contains an adjustable buckle on the headband.

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 and CDC / ISO 9001:2008 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 10 N95

US FDA/NIOSH N95 Approved Respirator DUCKBILL Mask Non-Sterile with Continuous Loop Headband

Pasture PM 10 Surgical N95 Respirator

Material Description

US FDA APROVAL Class II / NIOSH APPROVAL: TC-84A-4541

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 @ 120mm Hg of pressure

Textile Flammability: Class I – No 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 10 filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-4541

Manufacturing Facilities: ISO 13485 / ISO 9001:2015

Indication for Use: Pasture PM 10, 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.