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

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

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