face mask type ii, 3˜ply |pp - masterpiece · amanda kreuzmann quality management tested according...
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PRODUCT DESCRIPTION excellent filter performance > 99% BFE reinforced PP outer layer for even better filter and protection
results low exhalation resistance for comfortable wearing non-sterile, lint-free, skin-friendly integrated nose clip, anatomically and individually easy
to shape in a practical dispenser box of 50 pieces
MATERIAL light polypropylene nonwoven 3-ply blue
APPLICATION AREAfor industry and the medical and care sector
APPLICATION pull out face mask with dry and clean hands place side with the nose clip on the bridge of your nose pull both elastic bands behind your ears fan the face mask downward once mouth and nose area is completely covered,
shape and press the nose clip around the nose
AVAILABLE SIZES Universal, 17.5 x 9 cm Not suitable for children under 3 years
DURATION OF APPLICATION depending on the intensity of use and area of use, a
maximum wearing time of 2 hours is recommended to be changed after every moistening and visible
contamination
TESTED AND DECLARED ACCORDING TO
This item is a Class I medical device, classified and manu factured in accordance with the medical device regulation (MDR) (EU) 2017/745. The performance requirements result from EN 14683 as follows:
SHELF LIFE AND STORAGE 5 years in the original packaging store cool and dry protect from direct sunlight
The full text of the EU declaration of conformity is available at the following internet address: www.franz-mensch.de.
AVAILABLE SIZES
EN 14683TYPE IIMDR
(EU) 2017/745
Franz Mensch GmbHWerner-von-Siemens-Str. 2, 86807 Buchloewww.franz-mensch.de
Franz Mensch is a certified company according to DIN EN ISO 9001:2015
FACE MASK TYPE II, 3PLY |PPProduct information for item no. 29176
Test TYPE I TYPE IR TYPE II TYPE IIR
Bacterial filtration efficiency > 95% > 95% > 98% > 98%
Differential pressure Pa < 29.4 < 49.0 < 29.4 < 49.0
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Franz Mensch GmbHWerner-von-Siemens-Str. 2, 86807 Buchloewww.franz-mensch.de
Franz Mensch is a certified company according to DIN EN ISO 9001:2015
FACE MASK TYPE II, 3PLY |PPProduct information for item no. 29176
EU Declaration of Conformity for a class I medical deviceaccording to Annex VIII of Regulation (EU) 2017/745
The manufacturer, established in the European Community:
Franz Mensch GmbHWerner-von-Siemens-Str. 2D -86807 Buchloe, Germany
declares under their sole responsibility, that the medical device(s) mentioned below
PP - Mouth guard with rubber bands, 3-ply, blue, one sizeHYGOSTAR – Face Mask 3-ply Type II (99%)
29176, 29186
in accordance with confirmed records, test results or certificates, complies/complywith the requirements of the Regulation (EU) 2017/745 on medical devices and with the relevant Union harmonization legislation:
EN 14683
The achieved performance levels of this surgical mask correspond to TYPE II.
Signed for and on behalf of Franz Mensch GmbH:
Buchloe, May 13, 2020
___________________________Amanda KreuzmannQuality Management
EU Declaration of Conformity for a class I medical device according to Annex VIII of Regulation (EU) 2017/745
The manufacturer, established in the European Community:
Franz Mensch GmbH Werner-von-Siemens-Str. 2 D -86807 Buchloe, Germany
declares under their sole responsibility, that the medical device(s) mentioned below
PP - Mouth guard with rubber bands, 3-ply, blue, one size
HYGOSTAR – Face Mask 3-ply Type II (99%) 29176, 29186
in accordance with confirmed records, test results or certificates, complies/comply with the requirements of the Regulation (EU) 2017/745 on medical devices and with the relevant Union harmonization legislation:
EN 14683
The achieved performance levels of this surgical mask correspond to TYPE II. Signed for and on behalf of Franz Mensch GmbH: Buchloe, May 13, 2020 ___________________________
Amanda Kreuzmann Quality Management
Tested according to the European standard for medical face masks
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Franz Mensch GmbHWerner-von-Siemens-Str. 2, 86807 Buchloewww.franz-mensch.de
Franz Mensch is a certified company according to DIN EN ISO 9001:2015
FACE MASK TYPE II, 3PLY |PPProduct information for item no. 29176
Aboveaverage filter performance