FDA Approved Surgical N-95 Respirators
TECHNICAL DATA SHEET F550S
USFDA/NIOSH N95 Approved Respirator DUCKBILL Mask non-sterile with continuous loop headband
Pasture F550S
Material Description
| Filter layers: | 5 layers of non-woven fiber containing filter web in the middle |
| Outer layer: | Polypropylene Spunbond |
| Filter Media: | Polypropylene Meltblown |
| Inner layer: | Polypropylene Spunbond |
| Elastic bands: | Synthetic elastic (no latex material), suitable length for secure fit |
| Nose-piece: | Combination of zinc wires and embedded polyethylene inside of layers |
| Nose-cushion: | Polypropylene |
| Color: | White |
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
| Filter layers: | 5 layers of non-woven fiber containing filter web in the middle |
| Outer layer: | Polypropylene Spunbond |
| Filter Media: | Polypropylene Meltblown |
| Inner layer: | Polypropylene Spunbond |
| Elastic bands: | Synthetic elastic (no latex material), suitable length for secure fit |
| Nose-piece: | Combination of zinc wires and embedded polyethylene inside of layers |
| Nose-cushion: | Polypropylene |
| Adjustable Buckle: | Acrylonitrile Butadiene Styrene |
| Color: | White |
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 A520 S N95
US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Continuous Loop Headband
Pasture A520 S Surgical N95
Material Description
| Filter Layers: | Polypropylene |
| Outer Layer: | Polypropylene |
| Support Layer: | PET |
| Inner Layer: | Polypropylene |
| Elastic Bands: | Synthetic rubber, Tetoron |
| Color: | White |
US FDA APROVAL Class II / NIOSH APPROVAL: N95 TC-84A-7454
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 0.3μm
Differential Pressure (DP): < 14mm of H2O/cm2
Breathability (DP): Ezy-Breathe Technology
Fluid Resistance: Resists Synthetic Blood @ 160mm 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 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 A520 S filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-7454
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture A520 S is a NIOSH certified N95 respirator, and is 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 A520 CS N95
US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Adjustable Clip
Pasture A520 CS Surgical N95
Material Description
| Filter Layers: | Polypropylene |
| Outer Layer: | Polypropylene |
| Support Layer: | PET |
| Inner Layer: | Polypropylene |
| Elastic Bands: | Synthetic rubber, Tetoron |
| Color: | White |
US FDA APROVAL Class II / NIOSH APPROVAL: N95 TC-84A-7454
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 0.3μm
Differential Pressure (DP): < 14mm of H2O/cm2
Breathability (DP): Ezy-Breathe Technology
Fluid Resistance: Resists Synthetic Blood @ 160mm 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 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 A520 CS filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-7454
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture A520 CS is a NIOSH certified N95 respirator, and is 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. A520 CS is the same respirator as the A520 S, except A520 CS 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 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 E520 S N95
US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Continuous Loop Headband
Pasture E520 S Surgical N95
Material Description
| Filter Layers: | Polypropylene |
| Outer Layer: | Polypropylene |
| Support Layer: | PET |
| Inner Layer: | Polypropylene |
| Elastic Bands: | Synthetic rubber, Tetoron |
| Nose-piece: | Aluminum |
| Nose-cushion: | PU |
| Color: | White |
US FDA APROVAL Class II / NIOSH APPROVAL: N95 TC-84A-7453
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 0.3μm
Differential Pressure (DP): < 14mm of H2O/cm2
Breathability (DP): Ezy-Breathe Technology
Fluid Resistance: Resists Synthetic Blood @ 160mm 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 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 E520 S filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-7453
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture E520 S is a surgical N95 respirator, and 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
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 E520 CS N95
US FDA/NIOSH N95 Approved Respirator CONE-SHAPED Mask Non-Sterile with Adjustable Clip
Pasture E520 CS Surgical N95
Material Description
| Filter Layers: | Polypropylene |
| Outer Layer: | Polypropylene |
| Support Layer: | PET |
| Inner Layer: | Polypropylene |
| Elastic Bands: | Synthetic rubber, Tetoron |
| Nose-piece: | Aluminum |
| Nose-cushion: | PU |
| Color: | White |
US FDA APROVAL Class II / NIOSH APPROVAL: N95 TC-84A-7453
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 0.3μm
Differential Pressure (DP): < 14mm of H2O/cm2
Breathability (DP): Ezy-Breathe Technology
Fluid Resistance: Resists Synthetic Blood @ 160mm 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 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 E520 CS filtering face-piece respirator has been manufactured for Pasture Pharma Pte Ltd under approval TC-84A-7453
Manufacturing Facilities: ISO 13485 / ISO 9001:2015
Indication for Use: Pasture E520 CS is a surgical N95 respirator, and 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. E520 CS is the same respirator as the E520 S, except E520 CS 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 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
| Filter Layers: | 4 layers |
| Outer Layer: | Polyester |
| Filter Media: | Meltblown |
| Inner Layer: | Polypropylene |
| Rubber Bands: | White color, suitable length and fully adjustable loop head-straps for secure fit |
| Nose-piece: | Plastic material |
| Nose-cushion: | Foam |
| Color: | White |
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.
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.