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The Goods DDP team is a team with successful 20 years of experience in international supply.

Care About All Clients

We take care of all the issues of paperwork and delivery, so that you simply receive the goods in your warehouse

Communication

We accompany our customers all the way – from the first consultation to receiving the goods in your warehouse

FAQ

ABOUT OUR WORK

We offer our clients a comprehensive turnkey service. We optimize all internal processes for manufacturing, logistics and customs clearance of cargo. We remove headaches and a lot of approvals from our clients and choose the best schemes and methods depending on the market situation.

Our motto is that it is easier to prevent the possibility of risks than to eliminate the consequences. We carry out control at all stages-because we are interested in eliminating all risks during production, acceptance, and logistics. In addition, we welcome customers ‘ decisions to order inspection of the finished batch from the market leader in inspection control – the Swiss company SGS.

By ensuring optimal utilization of production capacity and planning logistics in advance, we achieve a reduction in the time of production and delivery of orders.

We try to have a stock of goods and plan production load so that while the payment is being made from the customer, we are already producing the goods for him. Our capabilities allow us to produce up to 10 million masks per day.

THE REFERENCE MASKS

In the Operating Room (OR), surgical masks protect the sterile field from possible contamination, primarily as a result of coughing, sneezing or talking. A mask may also protect clinicians from the byproducts of surgical procedures such as bone chips, splashes of body fluids, and smoke plume resulting from laser or electrosurgical techniques. Outside of the OR masks are used for standard precautions to protect clinicians and patients from pathogens that may spread by blood or other body fluids, secretions or excretions. Surgical and procedure masks are effective against droplet transmission.

A surgical mask is used inside the operating room or during other sterile procedure areas to protect the patient environment from contamination. It also protects the clinician from contaminated fluid or debris generated during the procedure. Surgical masks have ties so that they can be adjusted for fit, and are tied over top of a surgical or bouffant cap. A procedure mask is used for performing patient procedures, or when patients are in isolation to protect them from potential contaminants. They are used to protect both patients and staff from the transfer of respiratory secretions or other fluids or debris. They are used for ‘respiratory etiquette’ to prevent people from spreading germs via talking, coughing, or sneezing. Procedure masks have ear loops for quick donning, and since they do not slide on the hair can be worn without a surgical cap.

The filtration efficiency and protective ability of a face mask is compromised when the mask becomes wet, torn or dislodged. Generally speaking, the higher protection value of a mask the longer it will maintain filtration, however there is no set rule for how long a mask should be worn as it depends on humidity levels, respiration rate, nasal discharge, talking, etc. A mask should be worn for only one patient procedure or visit. If a mask gets wet or soiled it should be replaced.

A mask is only as effective as its fit. There should be no gaps along the side, around the nose or under the chin that would allow air and droplets to bypass the filter medium. The mask should always be properly adjusted to fully cover both the mouth and nose. A well-fitting mask stays in place over the nose and cheeks and even a regular mask will prevent fogging of eyeglasses if it fits properly. Masks should not be worn underneath the nose or dangling around the neck – they should either be fully on, or disposed of.

There are several things that contribute to a good fit. The most important consideration is the nose piece. It should mold over the nose and cheeks and maintain its shape over time. It should not kink or break when adjusted. Individuals with wider faces should select a mask that ensures full coverage over the face and under the chin. The upper tie should sit at the crown of the head, and the lower tie should be tied behind the neck to hold the sides of the mask against the face to prevent any gaping.

There are several things that contribute to a good fit. The most important consideration is the nose piece. It should mold over the nose and cheeks and maintain its shape over time. It should not kink or break when adjusted. Individuals with wider faces should select a mask that ensures full coverage over the face and under the chin. The upper tie should sit at the crown of the head, and the lower tie should be tied behind the neck to hold the sides of the mask against the face to prevent any gaping.

Specifications developed by the American Society of Testing and Materials (ASTM) in 2004 are referenced by the FDA as the required standard in the USA. The current standard ASTM F2100-07 (2007) specifies the performance requirements for Medical Face Masks with five basic criteria:

  • BFE (bacterial filtration efficiency) measures how well the mask filters out bacteria when challenged with a bacteria-containing aerosol. ASTM specifies testing with a droplet size of 3.0 microns containing Staph. aureus (average size 0.6-0.8 microns). In order to be called a medical/surgical mask, a minimum 95% filtration rate is required. Moderate and high protection masks have bacterial filtration rates of 98% to greater than 99%. Some manufacturers use the Modified Greene &Vesley method to determine the BFE rating. This method is NOT recommended by ASTM for product comparison or evaluating consistency.
  • PFE (particulate filtration efficiency) measures how well a mask filters sub-micron particles with the expectation that viruses will be filtered in a similar manner. The higher the percentage, the better the mask efficiency. Although testing is available using a particle size from 0.1 to 5.0 microns, ASTM F2100-07 specifies that a particle size of 0.1 micron be used. When comparing test results it is important to note the size of the test particles used, as use of a larger particle size will produce a misleading PFE rating.
  • Fluid Resistance reflects the mask’s ability to minimize the amount of fluid that could transfer from the outer layers through to the inner layer as the result of a splash or spray. ASTM specifies testing with synthetic blood at pressures of 80, 120, or 160 mm Hg to qualify for low, medium, or high fluid resistance. These pressures correlate to blood pressure: 80 mm Hg = venous pressure, 120 mm Hg = arterial pressure, and 160 mm Hg correlates to potential high pressures that may occur during trauma, or surgeries that include high pressure irrigation such as orthopedic procedures.
  • Delta P (pressure differential) measures the air flow resistance of the mask and is an objective measure of breathability. A controlled flow of air is driven through a mask and the pressure on either side of the mask is determined. The difference in pressure is measured and divided by the surface area (cm2) of the mask segment tested. The higher the Delta P value, the harder it is for the wearer to breathe. The Delta P is measured in units of mm H2O/cm2. The ASTM standard requires that masks have a Delta P of less than 5.0, as a higher value would be considered too “hot” for general medical or surgical use. Masks with a Delta P of less than 4.0 are considered acceptable, while masks with a Delta P less than 2.0 would be considered “cool”.

Flammability: Operating rooms contain sources of oxygen and other gases used for anesthesia, and there are potential fire hazards from electrosurgical procedures such as lasers or cautery equipment. All products used within the operating room, including face masks, are tested for flame resistance. As part of ASTM F2100 testing, masks must withstand exposure to a burning flame (within a specified distance) for three seconds.

ASTM F2100-07 (2007) REQUIREMENTS FOR MEDICAL FACE MASKS

Test :
BFE (Bacterial Filtration Efficiency)
at 3.0 micron ASTM F2101
PFE (Particulate Filtration Efficiency)
at 0.1 micron ASTM F2299
Delta P (Differential Pressure)
MS 36954C
Fluid Resistance to synthetic blood
ASTM 1862
Flammability
16 CFR part 1610

European Standard EN 143 defines the following classes of particle filters that can be attached to a face mask:
CLASS FILTER PENETRATION LIMIT (ata 95L/min air flow)
P1 Filters at least 80% of airborne particles
P2 Filters at least 94% of airborne particles
P3 Filters at least 99.95% of airborne particles

European Standard EN 149 defines the following classes of “filtering half masks” (also called filtering face pieces) that is respirators that are entirely or substantially constructed of filtering material:
CLASS FILTER PENETRATION LIMIT (at 95L/min air flow)
FFP1 Filters at least 80% of particles <22% inward leakage
FFP2 Filters at least 94% of particles <8% inward leakage
FFP3 Filters at least 99% of particles <2% inward leakage

The Approval is issued only to a specific and complete respirator assembly after the respirator has been evaluated in the laboratory and found to comply with all the requirements of Title 42, Code of Federal Regulations, Part 84. All the components must have the NIOSH approval label. If a manufacturer’s facility has an approval number on one respirator it does not mean that all their respirators are approved just that specific model.

Recent CDC infection control guidance recommends that healthcare workers protect themselves from diseases potentially spread through The air by wearing a fit tested respirator at least as protective as a NIOSH approved N95 respirator. An N95 respirator is one of nine types of disposable particulate respirators. Particulate respirators are also known as “air purifying respirators” because they protect by filtering particles out of the air you breath. The air-purifying respirator forces contaminated air through a filtering element. Workers can wear any one of the particulate respirators for protection against these diseases.

NIOSH- approved disposable respirators are marked with the manufacturer’s name, the part number (P/N), the protection provided by the filter (e.g. N95), and “NIOSH”.

N95 Filters at least 95% of airborne particles. Not resistant to oil
N99 Filters at least 99% of airborne particles. Not resistant to oil
N100 Filters at least 99.7% of airborne particles. Not resistant oil
R95 Filters at least 95% of airborne particles. Somewhat resistant
R99* Filters at least 99% of airborne particles. Somewhat resistant
R100* Filters at least 99.97%of airborne particles.Somewhat resistant
P95 Filters at least 95% of airborne particles. Strongly resists oil
P99* Filters at least 99% of airborne particles. Strongly resists oil
P100 Filters at least 99.97% of airborne particles. Strongly resists oil
* No NIOSH approvals are held by this type of disposable particulate Respirator

NOTE: particle size is 0.3 micron penetrating particle size (MPPS), Diffusion and interception predominate

The N95 surgical face mask has been recommended by USA experts as the best protection from SARS. The mask has a >99% BFE (Bacterial Filtration Efficiency). The N95 is the USA equivalent of the European P2 and P3 masks with the P3 offering the higher protection. The N95 mask has a Particle Filtration Efficiency (PFE) of >95% @ 0.3 micron. Masks are intended for use in infection control practices.

The P1 disposable dust respirators are suitable for protection against mechanically generated particles to 1 micron, such as dust and mist. Uses include: sawing, drilling, woodworking, sanding grinding and gardening.

Standard Tie On and Earloop Face Masks are the typical disposable face mask which is latex free, hypoallergenic, fiberglass free, fluid resistant and has a three ply construction. These face masks minimize patient contamination to exhaled microorganisms. Offers a >99% Bacterial Filtration Efficiency (BFE).

All means of personal protection suits against chemical substances can be classified into types Type 1 – Type 6

Type 1 EN 943-1 EN943-2 gas-tight workwear.
Type 2 EN 943-1 gas Permeable clothing.
Type 3 EN 14605 liquid Impermeable workwear
Type 4 EN 14605 aerosol-Proof workwear.
Type 5 EN ISO 13982-1 Protection against dry particles.
Type 6 Protection against light splashes.

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