FFP2 NR respirators. Clear answers.

FFP2 stands for filtering facepiece, protection class 2. It is a particle filtering half mask that covers the nose, mouth and chin and protects the wearer against airborne particles such as dust, smoke, fine aerosols and droplets. In the European Union, FFP2 respirators are tested to EN 149:2001+A1:2009 and sold as personal protective equipment (PPE) under Regulation (EU) 2016/425.

NR means non reusable. An FFP2 NR respirator is designed for a single work shift and must be discarded afterwards. The alternative marking R means the respirator has passed additional tests for reuse. The MOONLEX MM2-S is classified FFP2 NR.

The three classes set different limits under EN 149. Filter penetration may not exceed 20 % for FFP1, 6 % for FFP2 and 1 % for FFP3. This means the filter material captures at least 80 %, 94 % and 99 % of the test particles. Total inward leakage, which includes air entering around the edges, is also limited more strictly as the class rises. FFP2 is the most widely used class for general occupational and everyday protection.

They are comparable in filtration but certified under different systems. N95 is a United States classification approved by NIOSH. FFP2 is the European classification under EN 149, tested with both sodium chloride and paraffin oil aerosols and including a total inward leakage test on human wearers. For products sold as PPE in the European Union, the legally relevant marking is FFP2 with CE marking under Regulation (EU) 2016/425.

A surgical mask is a medical device tested to EN 14683. Its main purpose is to protect the patient and the surroundings from the wearer, and it usually fits loosely. An FFP2 respirator is personal protective equipment that protects the wearer. It seals to the face and filters inhaled air to a defined standard.

FFP2 respirators filter airborne particles, including fine aerosols and droplets that can carry viruses and bacteria. How well a respirator protects in practice depends on a good fit, correct use and changing it when required. FFP2 respirators do not protect against gases or vapours.

FFP2 respirators are used in healthcare and pharmacies, laboratories, construction, woodworking, agriculture, cleaning and facility services, logistics, and by the public where authorities recommend them. The right protection class for a workplace should always follow a risk assessment.

Yes. The MM2-S is certified as an FFP2 NR particle filtering half mask to EN 149:2001+A1:2009 and as Category III PPE under Regulation (EU) 2016/425. The notified body is CIS INSTITUT d.o.o., identification number 2890. EU type examination certificate No. 263453040080 is valid until 09.06.2031.

EN 149:2001+A1:2009 is the European standard for filtering half masks that protect against particles. It defines the FFP1, FFP2 and FFP3 classes and sets the tests for filter penetration, total inward leakage, breathing resistance, carbon dioxide content of the inhaled air, flammability, strength of the ear loops and marking.

Regulation (EU) 2016/425 sorts personal protective equipment into three categories by risk. Category III covers risks that can cause very serious consequences such as death or irreversible damage to health, which includes harmful substances in the air we breathe. Category III products need a notified body both for the EU type examination and for ongoing checks of production.

The CE marking shows that the product meets the applicable EU requirements. The number after it identifies the notified body that supervises production. 2890 is the identification number of CIS INSTITUT d.o.o., the notified body responsible for the MM2-S.

They are the conformity assessment procedures used for the MM2-S. Module B is the EU type examination, in which the notified body tests the respirator design against EN 149 and issues the certificate. Module C2 is conformity to type with supervised product checks at random intervals, which confirms that respirators from ongoing production still match the certified type.

Ask the supplier for the EU type examination certificate and the EU declaration of conformity. Check that the model name matches the product, that the certificate is still valid, and that the notified body number on the packaging matches the certificate. You can confirm the notified body and its scope in the European Commission NANDO database. MOONLEX provides the full documentation set with every quote.

The EU type examination certificate, the EU declaration of conformity, the Module C2 product check documentation and the technical data sheet for the MM2-S. They are sent with your quote or on request.

In testing by CIS INSTITUT, the highest measured filter penetration was 0.14 % with sodium chloride and 1.93 % with paraffin oil, against an FFP2 limit of 6 %. The total inward leakage mean stayed below the 8 % limit. The full results are listed in the MM2-S specification.

Breathing resistance is well below the EN 149 limits. Inhalation resistance measured 0.38 mbar at 30 L/min against a limit of 0.7 mbar, and 1.44 mbar at 95 L/min against 2.4 mbar. Exhalation resistance measured 2.04 mbar against 3.0 mbar. The carbon dioxide content of the inhaled air was 0.80 %, below the 1.0 % limit.

The MM2-S is a folded respirator made of 5 layers of nonwoven material, with a water electret meltblown filter layer. It has a metal nose clip built into the nose area and 2 elastic ear loops. It has no exhalation valve, so exhaled air is filtered as well.

No. The MM2-S is free of latex and glass fibre.

The MM2-S comes in one size, 230 ± 10 mm by 122 ± 7 mm, designed for adult faces.

Yes. The white and black MM2-S are the same certified respirator. Both colours are covered by the same EU type examination certificate.

No. The MM2-S is non sterile personal protective equipment certified under Regulation (EU) 2016/425. It is not a medical device.

An FFP2 NR respirator is made for a single work shift. Replace it earlier if it becomes damaged, dirty or wet, or if breathing through it becomes difficult.

No. NR respirators are not designed to be reused, washed or disinfected. Cleaning can damage the filter layer and reduce protection. Use a new respirator for each shift.

1. Wash or sanitise your hands and check the respirator for damage.
2. Open the respirator and hold it with the nose clip at the top.
3. Place it over your nose, mouth and chin and put the ear loops behind your ears.
4. Press the nose clip with the fingertips of both hands so it follows the shape of your nose.
5. Check the seal: cover the respirator with both hands and breathe out sharply. If air escapes around the edges, adjust the nose clip and the fit and check again.

Always follow the user instructions supplied with the product.

A respirator only protects properly when it seals against the skin. Beards and stubble along the edge of the mask can prevent a good seal and let unfiltered air in. For full protection, the face should be clean shaven where the respirator touches it.

Fogging usually means warm exhaled air is escaping over the nose. Shape the nose clip closely to your nose, then check the seal again. Resting the glasses slightly lower on the respirator can also help.

Replace it at once if it is damaged or deformed, if breathing becomes difficult, or if you have removed it in a contaminated area. Leave the contaminated area before taking a respirator off.

Remove it by the ear loops without touching the front, place it in a closed bin and wash your hands. In healthcare and other workplaces, follow the local rules for contaminated waste.

The MM2-S has a shelf life of 3 years from the date of manufacture when stored as recommended. The expiry date is marked on the packaging.

Store the respirators in a clean, dry place away from direct sunlight, at a temperature between −20 °C and +40 °C and below 80 % relative humidity.

No. After the expiry date the manufacturer can no longer confirm that filtration and fit meet the certified performance. Use respirators within the date marked on the packaging.

The MM2-S is manufactured by MOONLEX in Shtip, North Macedonia, on a 1,500 m² production site with 80 % automated production and human quality control on every batch. MOONLEX also has offices in Ljubljana, Slovenia and Maxdorf, Germany.

Yes. PPE placed on the EU market must comply with Regulation (EU) 2016/425 wherever it is produced. The MM2-S is certified by an EU notified body and carries the CE marking, so it can be sold throughout the European Union.

Delivery into the EU typically takes 3 to 5 days from dispatch. Your quote confirms the lead time for your quantity and destination.

• 1 respirator in a sealed hygiene pouch
• 10 respirators in a retail box
• 1,080 respirators in a master carton of 108 retail boxes
• 21,600 respirators on an EPAL pallet of 20 master cartons

Full loads hold 113,400 respirators in a van, 712,800 in a palletised truck and 855,360 in a floor loaded truck.

Yes. MOONLEX supplies hospitals, pharmacies, distributors, retailers, companies and public institutions. Volume pricing starts at pallet quantities. Prices are quoted excluding VAT, and the rate applied depends on the destination.

Yes. The MM2-S is also available on Amazon for smaller orders.

Yes. A private label programme is available from 200,000 units.

Yes. PZN coded retail boxes are available for the German pharmacy market.

Send your company details, delivery country and estimated quantity through the quote form, or contact us at contact@moonlex.mk or +389 78 222 777. A specialist replies with pricing, lead time and the full documentation set, normally within one business day.