3-layer disposable mouth masks type I / 95% filtration
These are packed per 50.
A large box contains 2000 masks.
CERTIFICATE / TEST REPPORT
Provided with all certificates.
CONDITIONS WITH WHICH THE SUPPLY OF MASKS MUST COMPLY TO BE RELEASED
For PPE masks, documents such as the EU declaration of conformity and the EU-type examination certificate, issued by a notified body ('notified body'), must be present that can demonstrate conformity of the products.
Given the exceptional situation, we take into account deviations from these rules for CE marking and conformity assessment as described in the European Recommendation 2020/403 of the European Commission of 13 March 2020 on conformity assessment and market surveillance procedures in the context of the COVID-19 threat.
Exceptionally, mouth masks are accepted that do not bear the CE marking, provided it is ensured that such products made available only to health professionals during the current crisis and that they the not enter regular distribution channels.
Exceptionally, certification or test reports according to equivalent international standards are also taken into account for the evaluation of the conformity assessment certification of mouth masks.
These alternative standards can be:
- European Union: EN 149 + A1: 2009 => FFP2 and FFP3
- Australia: AS / NZS 1716: 2012 => P3, P2
- Brazil: ABNT / NBR 13698: 2011 => PFF3, PFF2
- China: GB 2626-2006 => KN100, KP100, KN95, KP95
- Japan: JMHLW Notification 214, 2018 => DS / DL3, DS / DL2
- Korea: KMOEL-2017-64 => Special, 1st Class
- Mexico: NOM-116-2009 => N100, P100, R100, N99, P99, R99, N95, P95, R95
- USA: 42 CFR 84 => N100, P100, R100, N99, P99, R99, N95, P95, R95
This list can also be found on the site of CDC.