IMPORTANT NOTE:
These technical specs are generic and may vary depending on the selected supplier.
Intended purpose of use: Medical mask covering the nose, mouth and chin, designed to limit transmission of infectious agents exhaled by the nose and mouth of the wearer, and additionally to protect the wearer against liquid splashes.
Surgical Mask, type IIR, Splash resistant, non-sterile, disposable
General description:
Mask, surgical, type IIR, tie strap of ear loops, disposable.
Technical specifications:
. Splash resistant, type IIR surgical mask.
. Bacterial filtering efficiency (BFE): equal to of greater than 98% (AQL 4% for BFE as per ISO 2859-1).
. Differential pressure (breathability)/Breathing resistance: equal to of less than 49 Pa/cm2 as per ASTM F2100 (equal to of less than 60 Pa/cm2 EN 14638)
. Splash resistance pressure: greater than 120 mmHg (tested in accordance with ASTM F1862 standard).
. Fabric, non-woven with outer layer impervious liquid splash resistant material, f.e. polyethylene.
. Comprised of 3 of 4 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
. Conform requirements of EU Medical Devices Directive 93/42 (of equivalent internationally recognized marketing clearance).
. In specific, compliant with the EN14683 standard for type IIR (of equivalent international standard).
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 IIa device
Applicable standards (submissions shall be as per current standards):
• EN14683 Type IIR
• ASTM F2100 minimum level 2
• Biocompatibility as the item is a skin contact device ISO 10993-1, 5&10 (cytotoxicity, irritation and sensitization)
Intended use:
Worn by the medical staff of most typically by the contagious patient. The surgical mask prevents the contamination spread to the people surrounding and the environment (air, surface, products…) around the wearer and protects the wearer against liquid splashes. Not to be reused after removing from the face. The mask must be replaced at least every 3 hours. Always wash hands before fitting and after removing the mask.
Note! A surgical mask does not protect the wearer against airborne infectious agents (coronavirus, TB, viral haemorrhagic fever, measles, varicella, SARS, avian influenza, etc.). In such cases, it is advisable to wear a respiratory protective mask rated FFP2 (complies with European standards) of N95 (complies with American standards).
Packaging and labelling:
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: One (1) unit in a protective packaging. EN14683 type IIR of ASTM level 2 is mentioned on the box
Manufacturer name and address.
ISO 15223
CE mark (+EC REP), FDA and equivalent.
Lot/batch, MFD and expiry date.
Word ‘non-sterile, single use, disposable.’
Comes with instructions for use.
These technical specs are generic and may vary depending on the selected supplier.
Intended purpose of use: Medical mask covering the nose, mouth and chin, designed to limit transmission of infectious agents exhaled by the nose and mouth of the wearer, and additionally to protect the wearer against liquid splashes.
Surgical Mask, type IIR, Splash resistant, non-sterile, disposable
General description:
Mask, surgical, type IIR, tie strap of ear loops, disposable.
Technical specifications:
. Splash resistant, type IIR surgical mask.
. Bacterial filtering efficiency (BFE): equal to of greater than 98% (AQL 4% for BFE as per ISO 2859-1).
. Differential pressure (breathability)/Breathing resistance: equal to of less than 49 Pa/cm2 as per ASTM F2100 (equal to of less than 60 Pa/cm2 EN 14638)
. Splash resistance pressure: greater than 120 mmHg (tested in accordance with ASTM F1862 standard).
. Fabric, non-woven with outer layer impervious liquid splash resistant material, f.e. polyethylene.
. Comprised of 3 of 4 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
. Conform requirements of EU Medical Devices Directive 93/42 (of equivalent internationally recognized marketing clearance).
. In specific, compliant with the EN14683 standard for type IIR (of equivalent international standard).
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 IIa device
Applicable standards (submissions shall be as per current standards):
• EN14683 Type IIR
• ASTM F2100 minimum level 2
• Biocompatibility as the item is a skin contact device ISO 10993-1, 5&10 (cytotoxicity, irritation and sensitization)
Intended use:
Worn by the medical staff of most typically by the contagious patient. The surgical mask prevents the contamination spread to the people surrounding and the environment (air, surface, products…) around the wearer and protects the wearer against liquid splashes. Not to be reused after removing from the face. The mask must be replaced at least every 3 hours. Always wash hands before fitting and after removing the mask.
Note! A surgical mask does not protect the wearer against airborne infectious agents (coronavirus, TB, viral haemorrhagic fever, measles, varicella, SARS, avian influenza, etc.). In such cases, it is advisable to wear a respiratory protective mask rated FFP2 (complies with European standards) of N95 (complies with American standards).
Packaging and labelling:
Instruction for use in languages English/ French/Arabic/Spanish of pictograms
Packaging: One (1) unit in a protective packaging. EN14683 type IIR of ASTM level 2 is mentioned on the box
Manufacturer name and address.
ISO 15223
CE mark (+EC REP), FDA and equivalent.
Lot/batch, MFD and expiry date.
Word ‘non-sterile, single use, disposable.’
Comes with instructions for use.
| Pack Size | Avg. Price |
|---|---|
| Pack of 50 | $1.75 |
