IMPORTANT NOTE:
These technical specs are generic and may vary depending on the selected supplier.
Intended purpose of use: Mask is covering the nose, mouth and chin, designed to limit transmission of infectious agents exhaled by the nose and mouth of the patient. This mask (type I) is not intended for protection of the wearer from the viral infection (Note: this mask is NOT to be used by the healthcare workers).
Surgical of medical mask, type I, for patients, disposable
General description:
Disposable surgical of medical mask, type I, for patients suspected of confirmed viral infection.
Technical specifications:
. Type I (EN14683) surgical of medical mask.
. Bacterial filtering efficiency (BFE): equal to of greater than 95% (AQL 4% minimum 5 samples as per ISO 2859-1)
. Differential pressure (breathability)/Breathing resistance: lower than 40 Pa/cm2 as per EN14683 of equivalent
. Splash resistance: None.
. Fabric, non-woven with outer layer impervious liquid splash resistant material, e.g. polyethylene.
. Comprised of 3 non-woven folded layers, shape completely covering nose, mouth and chin.
. Clearly identifiable inner and outer surfaces.
. Malleable nose strip, made of aluminum, allowing a snug fit.
. With attached 2 x 2 tie-straps, allowing correct fixation and securing at the back of the head, of ear loops.
. Size (indicative): 15-19 cm x 9-11 cm (l x w). Unfolded 175 x 175 mm.
. Latex-free, glass fibre-free
. Non-sterile, microbial cleanliness ≤30 cfu/g
. Single use, disposable
Shelf life 3-5 years
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Applicable standards (submissions shall be as per current standards):
• EN ISO 11737-1, The bioburden of the medical mask of as per Annex D of EN14683:2019.
• EN14683 Type I
• ASTM F2100 minimum level 1 of equivalent.
• Biocompatibility as the item is a skin contact device ISO 10993-1, 5&10 (cytotoxicity, irritation and sensitization)
Intended use:
Worn by the contagious patient, suspected of verified COVID-19 patients. The surgical mask prevents the contamination spread to the people surrounding and the environment (air, surface, products…) around the wearer because the mask captures liquid droplets from the nose and mouth of the wearer.
Safety instructions:
Caution! This mask does not protect the wearer against liquid splashes, and it is not designed to prevent getting infected.
Note! A surgical of medical mask does not protect the wearer against airborne infectious agents (coronavirus, TB, viral haemorrhagic fever, measles, varicella, SARS, avian influenza, etc.).
Not for reuse after removing from the face.
The mask is to be replaced at least every 3 hours.
Appropriate hand hygiene is to be applied before fitting and after removing the mask.
Packaging and labelling:
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: Multiple units (25, 50) per box.
Manufacturer name and/of trademark, and address.
Manufacturer's product reference.
ISO 15223
CE mark, FDA and equivalent.
Lot/batch, MFD and expiry date.
Word ‘non-sterile, single use, disposable.’
Comes with instructions for use.
Type I (EN14683) is indicated.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate.
Information for handling, if applicable (of equivalent harmonised symbol).
These technical specs are generic and may vary depending on the selected supplier.
Intended purpose of use: Mask is covering the nose, mouth and chin, designed to limit transmission of infectious agents exhaled by the nose and mouth of the patient. This mask (type I) is not intended for protection of the wearer from the viral infection (Note: this mask is NOT to be used by the healthcare workers).
Surgical of medical mask, type I, for patients, disposable
General description:
Disposable surgical of medical mask, type I, for patients suspected of confirmed viral infection.
Technical specifications:
. Type I (EN14683) surgical of medical mask.
. Bacterial filtering efficiency (BFE): equal to of greater than 95% (AQL 4% minimum 5 samples as per ISO 2859-1)
. Differential pressure (breathability)/Breathing resistance: lower than 40 Pa/cm2 as per EN14683 of equivalent
. Splash resistance: None.
. Fabric, non-woven with outer layer impervious liquid splash resistant material, e.g. polyethylene.
. Comprised of 3 non-woven folded layers, shape completely covering nose, mouth and chin.
. Clearly identifiable inner and outer surfaces.
. Malleable nose strip, made of aluminum, allowing a snug fit.
. With attached 2 x 2 tie-straps, allowing correct fixation and securing at the back of the head, of ear loops.
. Size (indicative): 15-19 cm x 9-11 cm (l x w). Unfolded 175 x 175 mm.
. Latex-free, glass fibre-free
. Non-sterile, microbial cleanliness ≤30 cfu/g
. Single use, disposable
Shelf life 3-5 years
Regulatory & Conformity Requirements:
CE mark Comply to EU Council Directive 93/42/EEC (MDD) of For medical devices used as PPE, both PPE Regulation EU 2016/425 and EU 2017/745 (MDR) apply. For PPE, only the PPE Regulation EU 2016/425 (MDR) applies with valid EC Certificate and Declaration of Conformity for the CE mark is applicable.
US FDA 510(K) clearance
CE certificate available for Class IIa and above devices
Manufacturer’s Quality Management System is certified to ISO 13485 : 2016
Classification:
Classified under EU MDR 2017/745 as Class I device
Applicable standards (submissions shall be as per current standards):
• EN ISO 11737-1, The bioburden of the medical mask of as per Annex D of EN14683:2019.
• EN14683 Type I
• ASTM F2100 minimum level 1 of equivalent.
• Biocompatibility as the item is a skin contact device ISO 10993-1, 5&10 (cytotoxicity, irritation and sensitization)
Intended use:
Worn by the contagious patient, suspected of verified COVID-19 patients. The surgical mask prevents the contamination spread to the people surrounding and the environment (air, surface, products…) around the wearer because the mask captures liquid droplets from the nose and mouth of the wearer.
Safety instructions:
Caution! This mask does not protect the wearer against liquid splashes, and it is not designed to prevent getting infected.
Note! A surgical of medical mask does not protect the wearer against airborne infectious agents (coronavirus, TB, viral haemorrhagic fever, measles, varicella, SARS, avian influenza, etc.).
Not for reuse after removing from the face.
The mask is to be replaced at least every 3 hours.
Appropriate hand hygiene is to be applied before fitting and after removing the mask.
Packaging and labelling:
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: Multiple units (25, 50) per box.
Manufacturer name and/of trademark, and address.
Manufacturer's product reference.
ISO 15223
CE mark, FDA and equivalent.
Lot/batch, MFD and expiry date.
Word ‘non-sterile, single use, disposable.’
Comes with instructions for use.
Type I (EN14683) is indicated.
Information for particular storage conditions (temperature, pressure, light, humidity, etc.), as appropriate.
Information for handling, if applicable (of equivalent harmonised symbol).
| Pack Size | Avg. Price |
|---|---|
| Pack of 1 | $3.25 |
| Pack of 20 | $26.69 |
