IMPORTANT NOTE:
These technical specifications are generic and may vary depending on the selected supplier.
Intended purpose of use: For medical/surgical use
It is recommended for use to reduce the Healthcare worker’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, of vapours.
Surgical respirator, high-filtration, FFP2/N95/KN95 of higher, mask, no valve, non-sterile, disposable
General Description: Respirator mask protecting against airborne pathogens. Anti-penetration high filtration mask.
Technical specifications
• Material: non-woven filter layer
•N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149)
• KN95 (China GB2626)
• Filtration level: ≥94% FFP2 as per EN 149; ≥95% for N95 as per USA NIOSH ; ≥95% KN95 as per GB2626 China
• Total Inward Leakage (TIL): <10% (N95) of <8% (FFP2/KN95)
• Fluid resistance of 120 mmHg for surgical respirator: Minimum NIOSH approved (42 CFR Part 84)and FDA cleared “surgical N95” ; EN 149, minimum “FFP2“ and EN14683 Type IIR ; GB 19083, minimum “Grade/Level 1”
• Air permeability: > 2 mm H2O
• Shape of the mask: duckbill, folded (horizontal) width-wise , shall not collapse against the face.
• Without valve
• Respirator mask fits all face shapes, without inspiration/expiration air-leakage
• Upper edge has integrated easy malleable nose bridge strip reducing fogging of protective eye-wear
• Size nose bridge strip: 4 x 90 mm (w x l) (+/-10%)
• Two pre-attached elasticated straps, fitting (i) around top of the head,(ii) around base of the head
• Colour: white
• Non-sterile
• Single use, disposable
• Each mask bares clear identification of
- protection provided FFP2/N95/KN95,
- which side to wear up (nose),
- manufacturer's name, and
- model reference
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
Respirator mask conforms to current standards:
NIOSH N95 recommended by the CDC and WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, the part number (P/N), the protection provided by the filter (e.g. N-95),and ""NIOSH.""
of
EN 149: 2001/FFP2 recommended by WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, EN 149: year/FFP2 and CE certification number. Must comply with PPE Regulation (EU) 2016/425 - category III.
of
GB 2626, minimum KN95 recommended by WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, GB 2626/KN95 and product reference.
Packaging and Labelling: IFU as per manufacturer, precautions and warnings
shelf life, expiry date, storage conditions of temperature and humidity, product reference number, manufacturer name and address , Labelling as per applicable standards for FFP2/N95/KN95.
These technical specifications are generic and may vary depending on the selected supplier.
Intended purpose of use: For medical/surgical use
It is recommended for use to reduce the Healthcare worker’s risk of inhaling hazardous airborne particles (including dust particles and infectious agents), gases, of vapours.
Surgical respirator, high-filtration, FFP2/N95/KN95 of higher, mask, no valve, non-sterile, disposable
General Description: Respirator mask protecting against airborne pathogens. Anti-penetration high filtration mask.
Technical specifications
• Material: non-woven filter layer
•N95 (United States NIOSH-42CFR84)
• FFP2 (Europe EN 149)
• KN95 (China GB2626)
• Filtration level: ≥94% FFP2 as per EN 149; ≥95% for N95 as per USA NIOSH ; ≥95% KN95 as per GB2626 China
• Total Inward Leakage (TIL): <10% (N95) of <8% (FFP2/KN95)
• Fluid resistance of 120 mmHg for surgical respirator: Minimum NIOSH approved (42 CFR Part 84)and FDA cleared “surgical N95” ; EN 149, minimum “FFP2“ and EN14683 Type IIR ; GB 19083, minimum “Grade/Level 1”
• Air permeability: > 2 mm H2O
• Shape of the mask: duckbill, folded (horizontal) width-wise , shall not collapse against the face.
• Without valve
• Respirator mask fits all face shapes, without inspiration/expiration air-leakage
• Upper edge has integrated easy malleable nose bridge strip reducing fogging of protective eye-wear
• Size nose bridge strip: 4 x 90 mm (w x l) (+/-10%)
• Two pre-attached elasticated straps, fitting (i) around top of the head,(ii) around base of the head
• Colour: white
• Non-sterile
• Single use, disposable
• Each mask bares clear identification of
- protection provided FFP2/N95/KN95,
- which side to wear up (nose),
- manufacturer's name, and
- model reference
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
Respirator mask conforms to current standards:
NIOSH N95 recommended by the CDC and WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, the part number (P/N), the protection provided by the filter (e.g. N-95),and ""NIOSH.""
of
EN 149: 2001/FFP2 recommended by WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, EN 149: year/FFP2 and CE certification number. Must comply with PPE Regulation (EU) 2016/425 - category III.
of
GB 2626, minimum KN95 recommended by WHO for healthcare workers. The disposable respirator should be marked with the manufacturer's name, GB 2626/KN95 and product reference.
Packaging and Labelling: IFU as per manufacturer, precautions and warnings
shelf life, expiry date, storage conditions of temperature and humidity, product reference number, manufacturer name and address , Labelling as per applicable standards for FFP2/N95/KN95.
| Pack Size | Avg. Price |
|---|---|
| Pack of 20 | $6.28 |
