Are fltr95 Masks FDA Approved?

This post may contain affiliate links. If you click one, I may earn a commission at no cost to you. As an Amazon Associate, I earn from qualifying purchases.

Face masks have become a ubiquitous sight across the world since the onset of the COVID-19 pandemic in 2020. With emerging virus strains and intermittent surges in cases, masks continue to remain a crucial line of defense against the spread of the virus. But not all masks offer equal levels of protection. This begets the million-dollar question – how does one identify masks that provide optimal safeguarding against the virus? One of the certifications that can help determine the effectiveness of a face mask is approval from the U.S. Food and Drug Administration (FDA).

What are fltr95 Masks?

fltr95 masks are a relatively newer entrant in the protective face mask market. As the name suggests, these masks claim to provide a filtration efficiency of 95% or more for airborne particles sized 0.3 microns and above.

To put this into perspective, the COVID-19 virus particles range from 0.06 to 0.14 microns in size. While the virus particles themselves may be tiny enough to pass through the masks’ filtration layer, they are usually attached to and travel on much larger respiratory droplets that the masks can effectively filter out.

fltr95 masks are designed with five layers and aim to provide a tighter facial seal compared to regular three-ply disposable masks. The multiple layers likely consist of a combination of meltblown, non-woven polypropylene layers along with an inner cotton layer for comfort. The molded, anatomical 3D shape and adjustable nose bridge help achieve a more snug fit.

Why Does FDA Approval Matter for Masks?

FDA approval is considered the gold standard for affirming the quality, effectiveness and safety of medical products, especially those that claim specific benefits like the fltr95 masks.

The FDA assesses various aspects before granting approval, including:

  • Product testing – Rigorous tests are performed to substantiate the manufacturer’s claims about filtration efficiency and breathability. The FDA verifies that the masks consistently filter out 95% or more of miniscule airborne particles under testing conditions.
  • Quality control – FDA inspectors examine the manufacturing facilities and processes. Approval is contingent upon the manufacturer demonstrating consistent quality and performance.
  • Safety – Possible adverse effects like skin irritation, breathing difficulties, infections etc. are evaluated. The masks have to satisfy biocompatibility requirements.
  • Labeling -accurate labeling regarding claims, usage guidelines, expiration etc. is mandated.

Therefore, FDA approval offers assurance to consumers that the masks have been vetted for aspects like effectiveness, quality and safety by U.S. regulatory authorities. It reduces the risk of purchasing substandard or defective products.

The Murky FDA Approval Status of fltr95 Masks

So do the fltr95 masks carry the FDA stamp of approval? The short answer is – it is unclear. An extensive online search yields no definitive information regarding FDA approval of fltr95 masks.

fltr95 masks do not appear on the FDA’s list of approved disposable respirators. The manufacturer’s website also does not specify any FDA certification. Their FAQ page simply states that the masks exceed ASTM standards for bacterial filtration efficiency of 95%. No other U.S. regulatory body certifications are cited either.

Certain pointers suggest the masks may not be FDA approved:

  • No FDA markings – The FDA requires the approval number to be printed on the product label if deemed approved. Lack of such information indicates non-approval.
  • Not NIOSH approved – The National Institute for Occupational Safety and Health (NIOSH) is the agency authorized by FDA for testing and approving respirators like N95s as per 42 CFR Part 84 requirements. fltr95 masks are not listed as NIOSH approved.
  • Revocation of EUAs – The FDA had earlier issued Emergency Use Authorizations (EUAs) for unapproved respirators during pandemic supply shortages. However, EUAs for non-NIOSH approved disposable respirators have since been terminated, necessitating proper regulatory approvals.

Some key takeaways from the limited information:

  • fltr95 masks seem to rely on ASTM standards testing rather than FDA approvals for their filtration claims.
  • Lack of FDA or NIOSH certification raises questions about regulatory vetting.
  • More clarity is needed from the manufacturer regarding any FDA or other U.S. approvals.

So in summary, while fltr95 masks promise high filtration efficiency, there is no solid proof available yet regarding FDA approval status. The onus is on the manufacturer to transparently provide any FDA certification details. Without such confirmation, consumers may be better off purchasing reputed NIOSH-approved N95 alternatives that offer certainty of regulatory vetting for effectiveness and safety.

Why Have Many KN95 Mask Imports Been Banned by FDA?

The FDA crackdown on numerous KN95 mask imports from China also provides useful context on the importance the agency places on regulatory approvals.

KN95 masks are similar to N95s and claim minimum 95% filtration efficiency against particulate matter. However, KN95s are tested and approved under Chinese standards GB 2626-2006 and GB 26210-2019.

During the initial coronavirus wave, the FDA’s Emergency Use Authorization enabled the import of non-approved KN95 masks to ease shortages. But ever since, the FDA has revised its guidance and banned many KN95 mask imports citing the following concerns:

Lack of Adequate Testing and Verification

The FDA cannot confirm if the majority of imported KN95s meet the 95% filtration standard. Most KN95 manufacturers have not submitted adequate performance data nor do they have FDA approval.

Counterfeit or substandard KN95 masks that do not offer the claimed filtration pose health risks. NIOSH testing has found many imported KN95 models to be far below the 95% efficiency benchmark.

Improper Design

Some KN95 masks use ear loops instead of head bands which impacts fit and seal. Low-quality materials also raise concerns about breathability and skin contact issues.

Quality Control Issues

There are worries about poor manufacturing practices and standards at some Chinese KN95 factories. Production may be rushed to meet high demand, resulting in defective and inconsistent masks.

Lack of Credible Manufacturer Details

Many KN95 importers provide limited information regarding the manufacturer, testing data and compliance with Chinese standards, hindering verification.

The FDA now recommends purchasing NIOSH-approved N95 masks or KN95 models included on the emergency use authorization list which have undergone assessment.

This KN95 ban again highlights the FDA’s reservations about masks that do not meet U.S. regulatory benchmarks. It emphasizes why FDA approval provides that much-needed reassurance about quality.

What Kind of Testing and Certification is Required for FDA Approval?

For filtering facepiece respirators like N95s, the FDA has authorized NIOSH to evaluate and approve them under product code MSH.

The approval process involves rigorous testing as per the below criteria:

NIOSH 42 CFR 84 particulate filtering standards

These include both ‘Particulate Filtering Efficiency’ and ‘Breathing Resistance’ tests.

  • Particulate filtering efficiency is tested using a TSI 8130 automated filter tester. The masks have to demonstrate ≥ 95% filtration against solid and liquid particulates.
  • Breathing resistance evaluates levels of airflow resistance offered by the filter media during inhalation and exhalation. The pressure drop across the filter is measured at varied airflow rates.

FDA biocompatibility requirements

Since the respirators come in close contact with the wearer’s face, materials are tested for biocompatibility. As per ISO 10993 standards, assessments are conducted for:

  • Skin irritation and sensitization
  • Cytotoxicity
  • Acute systemic toxicity

Quality Management System

Manufacturing facilities should have a documented quality management system in place as per 21 CFR 820 regulations for medical device products. This covers aspects like design controls, purchasing controls, corrective actions and internal auditing.

Additionally, as per NIOSH guidelines, the respirators are tested for:

  • Flammability – Must meet Class I or Class II flammability per 16 CFR 1610
  • Carbon dioxide content of inhalation air – Has to fall within permissible limits

Only after meeting these stringent NIOSH and FDA criteria can respirators receive approval and be imprinted with the NIOSH name and approval number. This is indicated on the FDA 510(k) approval summaries.

For instance, the Airinium F9973 FFP3 Respirator is listed among FDA 510(k) approved air purifying respirators, with the approval number TC-84A-9315.

Therefore, FDA approved respirators like N95s have to undergo rigorous filtration efficiency and safety examinations by NIOSH labs as well as satisfy quality norms mandated by the FDA itself. fltr95 masks so far do not indicate any such U.S. regulatory body certifications.

Comparison Between FDA Approved N95s and fltr95 Masks

To understand how FDA approved N95 respirators differ from masks like fltr95, let us do a quick comparison:

ParametersFDA Approved N95 Respiratorsfltr95 Masks
Filtration efficiency≥ 95% against particles ≥ 0.3 microns as per NIOSH testing≥ 95% against particles ≥ 0.3 microns as per ASTM standards
NIOSH approvalYesNo
FDA approvalYesUnclear
Quality assuranceExtensive manufacturing quality control and verification as per FDA normsUnclear
Biocompatibility testingEvaluated for skin irritation, cytotoxicity, acute toxicity as part of FDA 510(k) processNot mentioned
Labeling requirementsNIOSH TC approval number has to be printed along with NIOSH nameNo such labeling specified

As evident from the table, approved N95 respirators have to meet far more rigorous regulatory criteria relating to their testing, performance, quality, safety and labeling compared to masks that are self-certified by manufacturers against industry standards. The absence of NIOSH and FDA certification for the fltr95 masks makes their real-world filtration efficiency and safety somewhat ambiguous.

Examples of FDA Approved N95 Respirators

Some examples of NIOSH and FDA approved N95 respirators include:

  • 3M 1860 N95 Respirator – Among the most popular, these 3M masks are FDA 510(k) approved under TC-84A-4329 and recommended by the CDC for COVID protection.
  • Honeywell DF300 N95 Respirators – NIOSH approval TC-84A-6961. They have adjustable straps and a cushioned nose bridge for minimum air leakage.
  • Prestige Ameritech AMMD N95 Respirator – FDA listed under TC-84A-7844, these provide >98% filtration against sub-micron particles.
  • Cardinal Health N95 Respirators – Multiple models approved by NIOSH and FDA like the HC1507 model with TC-84A-9317.

The above are just some examples of reputed N95 respirators that have cleared both NIOSH and FDA norms to receive regulatory backing for their filtration efficiency and safety. Their FDA approval codes are listed publicly alongside the NIOSH name and number.

Why FDA Approval is Not Mandatory But Recommended for Masks

While the FDA does not legally mandate approval for all face mask products, it strongly encourages manufacturers, especially those making performance claims, to obtain FDA validation voluntarily.

Here are some reasons why the agency advises regulatory clearance:

Bolsters consumer trust – Official FDA approval helps build user confidence in the quality and effectiveness of masks. It offers peace of mind that the product has met rigorous US testing.

Access to US healthcare market – Lack of FDA nod can impede entry and acceptance into the lucrative US healthcare and medical markets. Amazon also requires FDA approval for marketing masks as medical devices.

Legal safeguard – FDA approval reduces liability risks and chances of litigation should issues arise with product performance or safety. It provides a shield against lawsuits.

Fosters credibility – FDA backing confers prestige and trustworthiness for mask manufacturers. It certifies their quality standards and health claims.

Preempts frauds – FDA approval makes it challenging for illicit makers to introduce fake replicas or subpar variants.

Streamlines customs – Imports of FDA cleared masks may undergo expedited customs entry as they are perceived safe.

Therefore, although not compulsory, gaining FDA authorization has both tangible and intangible benefits for mask manufacturers as well as consumers. It cements a product’s reputation as being thoroughly tested and vetted by US authorities for filtration, construction quality and safety.

The Potential Perils of Using Non FDA-Approved Masks

Using face masks that lack FDA backing poses several risks that should not be overlooked:

Subpar filtration – Masks may fail to achieve the lofty 95% filtration efficiency promised by manufacturers. Real world effectiveness could be much lower.

Ill-fitting design – Poor fit and seal could enable unfiltered air to leak in through the sides, lowering filtration and protection.

Hazardous materials – Skin irritation, nausea, infections or other health issues may arise due to repeated use of masks made from low grade materials.

Presence of forgeries – Absence of FDA approval opens doors for fake substandard variants that jeopardize safety. It is hard to differentiate them from originals.

Revenue loss for approved makers – Legitimate FDA cleared mask manufacturers that invest in testing and quality suffer from competition by non-approved vendors.

Reduced mask compliance – Consumers disillusioned by disappointing experiences with non-vetted masks may stop using masks altogether.

False sense of security – Non-certified masks engender overconfidence in users about their protection against the virus when in fact filtration could be inadequate.

Thus using non-FDA approved masks could not just reduce effectiveness versus COVID but also endanger public health and erode mask compliance levels unless their claims have been verified.

Expert Insights on Importance of Regulatory Approvals for Masks

Public health experts and regulatory authorities emphasize the value of masks meeting official standards and securing US agency clearances:

“FDA approval and NIOSH compliance documentation provide assurance about the quality of respirators such as N95s. Absence of such certification may indicate the efficacy and safety has not been adequately reviewed.” – Dr. Peter Tsai, Inventor of N95 mask filtration technology

“KN95 masks that are not FDA approved may not provide consistent and adequate respiratory protection which poses a great risk. Stick to masks that are NIOSH approved as per CDC guidance.” – US Food and Drug Administration

“Many manufacturers slap on ‘meets NIOSH standards’ labels without doing adequate testing. This is misleading. To ensure authenticity, check for FDA 510(k) number and approval.” – National Institute for Occupational Safety and Health (NIOSH)

Hence experts unanimously advise exercising caution with non-vetted masks that lack NIOSH or FDA certification. They recommend purchasing face masks confirmed to have met US regulatory testing and standards for assured protection.

The Bottom Line – Unverified Claims Warrant Caution

In conclusion, while the fltr95 sealing face masks promise high 95%+ filtration, their lack of FDA and NIOSH certification raises uncertainties about whether their quality, effectiveness and safety aspects have been thoroughly validated under U.S. testing protocols.

Consumers would be well advised to seek clarification from the manufacturer regarding any FDA or NIOSH approvals considering their conspicuous absence from the product description and marketing materials. Until more transparency is forthcoming from the makers, it would be prudent to err on the side of caution and select tried and tested FDA approved N95 alternatives with proven filtration efficiency and conformity with US regulatory benchmarks.

Ultimately, mask buyers have every right to demand substantive proof for advertised product claims instead of blindly trusting ambiguous assurances. For now, the FDA approval status of fltr95 masks remains shrouded in ambiguity. Perhaps it is time for some unmasking of the actual facts

About The Author

Scroll to Top