FDA Approved Surgical N-95 Respirators

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.