Frequently Asked Questions

Category: Health Care Supplies / Diagnostics / Consultancy / Ventures

Health Care Supplies

What do Chinese mask numbers mean?

The following test standards indicate the tests the mask has undergone. GB 19083: Applies to the medical work environment, filtration of particulate matter in the air, barriers against droplets, blood, body fluids, secretions, and other self-absorption filter type medical protective masks. GB 2626: Applies to self-absorption filtered respiratory products for protection from various types of particulate matter. YY 0469: Applies to disposable surgical masks worn by clinical medical personnel during invasive operations, etc. YY/T 0969: Applies to single-use masks that cover the user’s mouth, nose, and jaw and are used in general medical settings for heavy wear to block exhaled or ejected contaminants from the mouth and nose. Not tested as medical protective equipment. GB/T 32610-2016: Applies to protective masks worn under air pollution in daily life to remove particulate matter. Not recommended for special industries such as medical industries.

What does PPE stand for?

PPE stands for Personal Protective Equipment and includes any device or appliance designed to be worn or held by an individual for protection against one or more health and safety hazards.

Are you available for government contracts?

Yes.

Where do you manufacture?

We work with high-quality manufacturers, mostly from China, Japan, Vietnam, the European Union, and North America.

How do you ship?

We use an independent contractor to safely ship via air or container. Using independent contractors helps us keep our low-price point promise while providing reliable service.

Where do you deliver?

We mainly supply clients in North America and the European Union. If you require shipping to any other destination, our legal team is ready and able to meet the regulatory needs in your country.

How does the Match-Manufacturer-Model work?

How does the Match-Manufacturer-Model work? It's our secret sauce. But here is the upshot: Daily requirements (in all their variations) must be significant enough for manufacturers in terms of modification and customization, while still allowing them to pursue other productions. Ideal manufacturers are those who already produce for prolific distributors such as Henry Schein, Cardinal, or Medline, but who also want to break free from exclusivity and selling to one client who can control them entirely.

How do you offer PPEs so much cheaper than my local vendor?

Simple: because we cut out all the middlemen between you, an end-user with large needs, and the producers. We use what we call a Matched-Manufacturer-Model. All the steps in between that are usually taken care of by different entities (documentation, insurance, logistics, importation, taxes, and storage) are handled by us instead. This means that for you, it’s as simple as it gets: great prices, impeccable quality, and the ability to modify any of your supplies to fit your needs.

Do you have 510(K) products?

Yes. We generally assess your needs from a regulatory perspective first and then find a supplier that meets the criteria. We can also help you get a 510(K) premarket notification -- or get it for you.

Are my needs large enough to work with Anzen?

Usually if you require an excess of 1,000 items per day, we can work together. If you need less, we are happy to put you in touch with trusted suppliers in your area that can help you.

Do you offer small quantities of stock?

Not usually -- we do not stock products. However, we are happy to manufacture a smaller quantity for you as a trial package.

Are you able to make products according to specification?

Yes. We work with manufacturers that adapt to your needs, so product modifications are generally possible.

Diagnostics

What is the Limit of Detection (LoD) for Covid tests?

Limit of Detection (LoD) is becoming increasingly important. Clarifi is able to identify much broader groups of people that are infected. Tests with higher LoDs will miss more infected patients, resulting in more false negatives.

Are rapid tests sufficiently accurate?

Generally speaking, rapid tests are less accurate than PCR tests -- but in the case of individual use, they may be enough. For serial testing (e.g. regular checks of large numbers of people) there is little scientific evidence that rapid tests can prevent COVID outbreaks. For these purposes, PCR tests remain the better option.

Consultancy

What class are PPEs?

Most PPE fall under class I or class II. Some identical products like face masks can be class I and class II depending on their use case. The word ‘surgical’ often implies use during surgery, which means it would be a class II product.

How does FDA classify medical devices?

All medical devices fall into one of three regulatory classes based on the level of control necessary to ensure the safety and effectiveness of the device. These classifications are risk-based. Devices in all three classes are subject to general controls: (1) Register their establishments and list the medical devices they market with FDA; (2) Manufacture their devices in accordance with Good Manufacturing Practices (3) Label their devices in accordance with labeling regulations. Class I devices are subject only to general controls. They typically present the lowest potential for harm and are more basic in design. Examples: elastic bandages, examination gloves, and hand-held surgical instruments. Class II devices require reasonable assurance of safety and effectiveness. In addition to compliance with general controls, Class II devices are also subject to special controls identified by the agency, which may include special labeling requirements, performance standards, and postmarket surveillance. Examples of Class II devices include powered wheelchairs, infusion pumps, and surgical drapes. Class III devices are the highest class and require strict controls. Examples of Class III devices include replacement heart valves, silicone gel-filled breast implants, and implanted cerebellar stimulators.

What is a medical device?

According to the FDA, a medical device is an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them, intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes (21 U.S.C. 321(h)).

What do I need to launch my medical product in Japan?

Japan’s medical device and pharmaceutical markets are special, as it is one of the few places that neither accepts FDA nor CE certifications. The manufacturer must instead go through a specific approval process to get their product certified by either the Minister’s Approval (shonin 承認), a third party Certification (ninsho 認証), or a Marketing Notification (todokede 届出). If you want to create a legal presence in Japan, you need a License for Marketing Authorization Holder (Seizohanbai-gyo-kyoka 製造販売業許可). While certifications from Europe and the US are not recognized, the actual review process is similar. During this process, PMDA evaluates the quality, efficacy, and safety of drugs, medical devices, and cellular/tissue-based products in light of current scientific and technological standards. To summarize, if your product or company has been certified in the US or Europe, you stand a reasonably good chance of eventually being certified in Japan. However, this can take several years and require significant investment, which can make it prohibitive for some companies.

What is the meaning of 510(K)?

A 510(K) is a required submission that must be made to the FDA to demonstrate that the proposed device or product is safe and effective BEFORE it can be sold or marketed. The reason a Premarket Notification is also referred to as a 510(k) is that it actually refers to section 510(k) of the Federal Food, Drug, and Cosmetic Act. This is why people often use the terms 510(k) and Premarket Notification interchangeably. You can simply check a 510(K) with the specific number on the FDA database.

Ventures

What kind of companies do you invest in?

We often invest in ideas that are transformative (and sometimes a little crazy). But more than crazy ideas, we invest in dedicated people. No matter what your ideas are, if you’re willing to see them through, we believe you can make it. Is this you? Then contact us at impact@anzenhealth.com

Anzen Health LLC.

4245 N. Knox Ave.

Chicago, IL 60641

+1 (312)-447-9471

info@anzenhealth.com

Our CompanyAboutCSRTeamPressFAQ

Services

Medical Supplies Pandemic Tools Consulting Ventures

Support

FDA Registration

FDA #: 3017235663

DUNS: 117548778

CAGE: 97YZ2