Innonix Antiviral Child's Face Mask

K192105 · Innonix Technologies Limited · OUK · Nov 29, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K192105
• Device Name: Innonix Antiviral Child's Face Mask
• Applicant: Innonix Technologies Limited
• Product Code: OUK · General, Plastic Surgery
• Decision Date: Nov 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4040
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6% and zinc 1.6%) that inactivate influenza viruses.

Device Story

Single-use, disposable face mask for children (ages 5-10); worn in healthcare settings under adult supervision. Four-layer construction: outer spun-bond polypropylene with hydrophilic citric acid (2%) coating; second layer of cellulose/polyester treated with copper (1.6%) and zinc (1.6%) ions; third layer of melt-blown polypropylene filter; inner spun-bond polypropylene layer. Operates via passive barrier protection and active viral inactivation; citric acid lowers pH to absorb droplets; metal ions disrupt viral structures. Inactivates influenza viruses, measles, and coronavirus upon contact. Available as flat-folded convex (with ear-loops and nose strip) or flat-pleated styles. Provides barrier protection for respiratory tract; intended to reduce exposure to pathogens. No clinical data; performance verified via in vitro viral inactivation and bench testing.

Clinical Evidence

No clinical data. Evidence consists of bench testing and in vitro viral inactivation studies. In vitro testing demonstrated >99.99% inactivation of various influenza strains, measles, and coronavirus within 1-5 minutes. Bench testing confirmed compliance with ASTM F2101 (BFE 99.5%), ASTM F2299 (PFE >99.5%), ASTM F1862 (fluid resistance 160mm Hg), and MIL-M-3654C (breathing resistance 2.5 mm H2O/cm²). Biocompatibility and pediatric safety (EN71, CPSC lead/phthalate) testing passed.

Technological Characteristics

Four-layer non-woven mask: spun-bond polypropylene, cellulose/polyester, melt-blown polypropylene (18 g/m²), and spun-bond polypropylene. Active layers: citric acid (2%) and copper/zinc ions (1.6% each). Features: malleable aluminum nose strip with polyurethane foam, polyamide/spandex ear-loops. Standards: ASTM F2100-11, F2101, F2299, F1862, MIL-M-3654C, 16 CFR 1610, ISO 10993-10/18, EN71-1/3, CPSC-CH-E1002-08/E1001-09.3.

Indications for Use

Indicated for children (ages 5-10) in healthcare settings under adult supervision to cover the nose and mouth as a barrier against microorganisms, body fluids, and particulates.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

• BioFriendTM BioMaskTM Surgical Facemask (K101128)

Reference Devices

• Prestige Ameritech Pediatric/Child's Face Mask (K160100)

Submission Summary (Full Text)

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November 29, 2019

Innonix Technologies Limited Reid Borsel US Agent For Innonix Technologies 10017 Sorrel Ave Potomac, Maryland 20854

Re: K192105

Trade/Device Name: Innonix Antiviral Child's Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OUK, OXZ Dated: October 30, 2019 Received: October 30, 2019

Dear Reid Borsel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal

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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

For Elizabeth Claverie, M.S. Assistant Director for THT4B2 Acting Assistant Director for THT4B1 DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K192105

Device Name Innonix Anti-Influenza Child's Face Mask

### Indications for Use (Describe)

The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child's Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avine and equine influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/ PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/ Florida/4/2006, B/Lee/1940). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the facemask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------|
| | |
| Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) |
| | <span></span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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# 510(k) Summary K192105

| Date Summary was Prepared: | November 28, 2019 | |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------|---------------|
| Submitter's Name: | Innonix Technologies Limited<br>(formerly Filligent Limited) | |
| Submitter's Address: | 13/F, LiFung Centre, 2 On Ping Street<br>Siu Lek Yuen, Shatin<br>Hong Kong | |
| Submitter's Telephone: | Phone [phone]<br>Fax [phone] | |
| US Contact Name: | Reid von Borstel (US Agent for Innonix Technologies Ltd)<br>[e-mail]<br>301-412-4060 | |
| Trade or Proprietary Name: | Innonix Anti-Influenza Child's Face Mask<br>Model: BF-200-3015A and BF-200-2005A | |
| 510(k) Number | K192105 | |
| Device Classification Name: | Pediatric/Child Face Mask with Antimicrobial/Antiviral Agent | |
| Classification Name: | CFR 21 878.4040 | |
| Panel: | General Hospital | |
| Product Code: | OUK<br>OXZ | |
| Predicate Device: | Device Name | 510(k) Number |
| | <b>Primary Predicate:</b><br>BioFriendTM BioMaskTM Surgical<br>Facemask OUK<br>Models: Universal BF-200-2001.<br>Premium BF-200-3013 | K101128 |
| | <b>Reference Device:</b><br>Prestige Ameritech Pediatric/Child's<br>Face Mask OXZ | K160100 |

#### 1. Device Description

The Innonix Anti-Influenza Child's Face Masks, (both Model BF-200-3015A and BF-200-2005A) comprise four layers of material: an outer layer of spun bond polypropylene, a second layer of cellulose/polyester, a third layer of melt-blown polypropylene filter material and an inner (fourth) layer of spun-bond polypropylene. All of the construction materials used in this device are typical construction materials commonly used in surgical facemasks and being used in current legally marketed devices, and are not made with natural rubber latex. The outer active layer of the face mask is coated with a hydrophilic plastic containing citric acid. The second inner layer is treated with copper and zinc ions. Both of these layers inactivate influenza viruses using different mechanisms of action (pH lowering and ionic disruption).

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Model: BF-200-3015A is flat-folded and expands into a convex-shaped mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

Model: BF-200-2005A is a flat pleated mask with polyamide/spandex elastic ear-loops to secure the mask to the user's face, and has a malleable aluminum strip covered with polyurethane foam positioned above the nose for a tighter seal around the nose and face.

#### 2. Indication for Use

The Innonix Anti-Influenza Child's Face Mask (Models BF-200-3015A and BF-200-2005A) is a single use, disposable device that is intended to be worn by children (recommended ages 5-10) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms, body fluid and particulate materials. The mask is specifically for child or pediatic patients to provide protection for the respiratory tract. This face mask is recommended for use in a healthcare setting with appropriate adult supervision. The Innonix Anti-Influenza Child's Face Mask has hydrophilic plastic coating (active ingredient: citric acid 2%, a pH lowering agent) that rapidly absorbs aerosol droplets away from the outer surface of the mask and a second inner layer treated with metal ions (active ingredients: copper 1.6%) that inactivate influenza viruses.

The Innonix Anti-Influenza Child's Face Mask inactivated 99.99% of tested influenza viruses (≥4 log difference versus identical untreated control mask textiles) within five minutes of contact with the surface of the facemask in laboratory (in vitro) tests against the following seasonal, pandemic, avian, swine and influenza viruses: Influenza A subtypes and strains H1N1 (A/California/04/2009, equine A/Brisbane/59/2007, A/Wisconsin/10/1998, A/New Jersey/8/1976, A/PuertoRico/8/1934), H3N2 (A/Brisbane/10/2007, A/Wisconsin/67/2005), H2N2 (A/2/Japan/305/1957); the bird flu subtypes: H5N1 (NIBRG-14), H9N2 (A/Turkey/Wisconsin/1966), H5N2 (A/Duck/PA/10218/84); the swine flu subtype: H1N1 (A/Swine/1976/1931); the equine flu subtype: H3N8 (A/Equine/2/Miami/1963); and Influenza B strains: (B/Florida/4/2006, B/Lee/1940). The mask also inactivated >99.99% of Measles virus strain ATCC VR-24 and Coronavirus 229E strain ATCC VR-740 within one minute of contact with the surface of the face mask in laboratory in vitro tests. Correlation between in vitro results and any clinical event has not been tested.

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#### Technological Characteristic Comparison 3.

Comparison of the predicate device, BioFriend™ BioMask™ Surgical Facemask Models: Premium BF-200-3013A and Universal BF-200-2001A to Innonix Anti-Influenza Child's Face Mask, Models: BF-200-3015A and BF-200-2005A

| | BioFriend ™™ BioMask ™™<br>Surgical Facemask Convex<br>Model: BF-200-3013A and BF-200-<br>2001A | Innonix Anti-Influenza Child's<br>Face Mask,<br>Model: BF-200-3015A and BF-<br>200-2005A | Comparison of Subject<br>Device to Predicate |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| FDA Predicate<br># | K101128 | K192105 | N/A |
| Product Code | OUK | OUK<br>OXZ | Same: Both predicate and<br>subject devices use<br>identical virus-inactivating<br>materials in the first and<br>second active layers, and<br>the inner two textile layers<br>are identical as well.<br>Different: The subject<br>device is intended to be<br>worn by children.<br>The predicate device is a<br>medical device to be used<br>by adults. |
| Date Approved | May 26, 2011 | November 29, 2019 | N/A |
| Description | The BioFriend™ BioMask™ surgical<br>facemask is offered in two mask<br>styles, Models: Universal BF-200-<br>2001A and Premium BF-200 3013A.<br>The Universal model is a standard<br>flat mask with pleats, while the<br>Premium model is flat-folded and<br>expands into a convex-shaped<br>mask. The Premium model also has<br>ear adjusters and an anti-fog nose<br>flap. Both models comprise four<br>layers of material: an outer layer of<br>spun-bond polypropylene, a second<br>layer of cellulose/polyester, a third<br>layer of melt-blown polypropylene<br>filter material and an inner (fourth)<br>layer of spun-bound polypropylene.<br>All of the construction materials used<br>in this device are latex free and are<br>typical construction materials<br>commonly used in surgical<br>facemasks and being used in current<br>legally marketed devices, and are<br>not made with natural rubber latex.<br>The outer active layer of the<br>facemask is coated with a<br>hydrophilic plastic containing citric<br>acid. The second inner layer is<br>treated with copper and zinc ions.<br>Both layers inactivate influenza<br>viruses using different mechanisms<br>of action. | The Innonix Anti-Influenza Child's<br>Face Mask is offered in two<br>styles, Model: BF-200-3015A is<br>flat-folded and expands into a<br>convex-shaped mask with<br>polyamide/spandex elastic head-<br>loops to secure the mask to the<br>user's face, and a malleable<br>aluminum strip positioned above<br>the nose for a tighter seal around<br>the nose and face. Model: BF-<br>200-2005A is a standard flat<br>pleated mask. Both models<br>comprise four layers of material:<br>an outer layer of spun-bond<br>polypropylene, a second layer of<br>cellulose/polyester, a third layer<br>of melt-blown polypropylene filter<br>material and an inner (fourth)<br>layer of spun-bound<br>polypropylene. All of the<br>construction materials used in<br>this device are typical<br>construction materials commonly<br>used in surgical facemasks and<br>being used in current legally<br>marketed devices, and are not<br>made with natural rubber latex.<br>The outer active layer of the<br>facemask is coated with a<br>hydrophilic plastic containing<br>citric acid. The second inner layer<br>is treated with copper and zinc<br>ions. Both layers inactivate | Same: Both predicate and<br>subject devices use<br>identical virus-inactivating<br>materials in the first and<br>second active layers. All<br>four textile layers are<br>identical in the predicate<br>and subject masks.<br>Different: The subject<br>device is intended to be<br>worn by children, and is<br>appropriately smaller than<br>this predicate, which is of<br>an appropriate size to be<br>used by adults. |

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| | BioFriend ™™ BioMask ™™<br>Surgical Facemask Convex<br>Model: BF-200-3013A and BF-200-<br>2001A | Innonix Anti-Influenza Child's<br>Face Mask,<br>Model: BF-200-3015A and BF-<br>200-2005A<br>influenza viruses using different<br>mechanisms of action. | Comparison of Subject<br>Device to Predicate | | |
|--------------------------------------|-------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | (BF-200-2001A) - is a standard flat | The BioFriend™™ BioMask™™ surgical<br>facemasks are single use disposable<br>devices with a hydrophilic plastic<br>coating on the outer layer (active<br>ingredient: citric acid 2%, a pH<br>lowering agent), and a second inner<br>layer treated with metal ions (active<br>ingredients: copper 1.6% and zinc<br>1.6%, which form ionic bonds with<br>negatively-charged side-groups on<br>influenza viruses).<br><br>The BioFriend ™™ BioMask™™ surgical<br>facemasks kill (inactivate) 99.99% of<br>Influenza viruses (≥4-logs difference<br>versus identical but untreated mask<br>textiles) on five minutes contact with<br>the surface of the facemask in<br>laboratory (in vitro) tests against the<br>following seasonal, pandemic, avian,<br>swine and equine influenza viruses:<br>Influenza A subtypes and strains:<br>H1N1 (the 2009 pandemic flu<br>subtype A/California/04/2009,<br>A/Brisbane/59/2007,<br>A/Wisconsin/10/1998, A/New<br>Jersey/8/1976,<br>A/PuertoRico/8/1934), H3N2<br>(A/Brisbane/10/2007,<br>A/Wisconsin/67/2005), H2N2<br>(A/2/Japan/305/1957); the bird flu<br>subtypes: H5N1 (NIBRG-14), H9N2<br>(A/Turkey/Wisconsin/1966), H5N2<br>(A/Duck/PA/10218/84); the swine flu<br>subtype: H1N1<br>(A/Swine/1976/1931); the equine flu<br>subtype: H3N8<br>(A/Equine/2/Miami/1963); and<br>Influenza B strains:<br>(B/Florida/4/2006, B/Lee/1940),<br>under tested contact conditions.<br>There are two models: (1) Universal | A/Brisbane/59/2007, | The Innonix Anti-Influenza Child's<br>Face Mask (Models BF-200-<br>3015A and BF-200-2005A) is a<br>single use, disposable device that<br>is intended to be worn by children<br>(recommended ages 5-10) to<br>cover the nose and mouth to<br>provide a barrier for the<br>respiratory tract for<br>microorganisms, body fluid and<br>particulate materials. The mask is<br>specifically for child or pediatric<br>patients to provide protection for<br>the respiratory tract. This face<br>mask is recommended for use in<br>a healthcare setting with<br>appropriate adult supervision.<br>The Innonix Anti-Influenza Child's<br>Face Mask has hydrophilic plastic<br>coating (active ingredient: citric<br>acid 2%, a pH lowering agent)<br>that rapidly absorbs aerosol<br>droplets away from the outer<br>surface of the mask and a<br>second inner layer treated with<br>metal ions (active ingredients:<br>copper 1.6% and zinc 1.6%) that<br>inactivate influenza viruses.<br><br>The Innonix Anti-Influenza Child's<br>Face Mask inactivated 99.99% of<br>tested influenza viruses (≥4 log<br>difference versus identical<br>untreated control mask textiles)<br>within five minutes of contact with<br>the surface of the facemask in<br>laboratory (in vitro) tests against<br>the following seasonal,<br>pandemic, avian, swine and<br>equine influenza viruses:<br>Influenza A subtypes and strains<br>H1N1 (A/California/04/2009,<br>A/Brisbane/59/2007, | Same: Both predicate and<br>subject devices use<br>identical virus-inactivating<br>materials in the first and<br>second active layers. All<br>four textile layers are<br>identical in the predicate<br>and subject masks.<br><br>Different: The subject<br>device is intended to be<br>worn by children, and is<br>appropriately smaller.<br>The predicate device is a<br>medical device of an<br>appropriate size to be used<br>by adults. |
| mask with pleats; (2) Premium (BF- | A/Wisconsin/10/1998, A/New | | | | |
| 200-3013A) - flat-folded, expanding | Jersey/8/1976, | | | | |
| into a convex-shaped mask with ear | A/Puerto Rico/8/1934), H3N2 | | | | |
| adjusters and an anti-fog nose flap. | (A/Brisbane/10/2007, | | | | |
| No clinical studies have been | A/Wisconsin/67/2005), H2N2 | | | | |
| conducted comparing the ability of | (A/2/Japan/305/1957); the bird flu | | | | |
| an untreated facemask and these | subtypes: H5N1 (NIBRG-14), | | | | |
| facemasks to protect the wearer | H9N2 | | | | |
| from Influenza infection. They are | (A/Turkey/Wisconsin/1966). | | | | |

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| | BioFriend™ BioMask™<br>Surgical Facemask Convex<br>Model: BF-200-3013A and BF-200-<br>2001A | Innonix Anti-Influenza Child's<br>Face Mask,<br>Model: BF-200-3015A and BF-<br>200-2005A | Comparison of Subject<br>Device to Predicate |
|--------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| | intended to be worn by operating<br>room personnel during surgical<br>procedures, to protect both the<br>surgical patient, and the operating<br>room personnel, from the transfer of<br>micro-organisms, body fluids and<br>particulate material. | H5N2 (A/Duck/PA/10218/84); the<br>swine flu subtype: H1N1<br>(A/Swine/1976/1931); the equine<br>flu subtype: H3N8<br>(A/Equine/2/Miami/1963); and<br>Influenza B strains:<br>(B/Florida/4/2006, B/Lee/1940).<br>The mask also inactivated<br>>99.99% of Measles virus strain<br>ATCC VR-24 and Coronavirus<br>229E strain ATCC VR-740 within<br>one minute of contact with the<br>surface of the facemask in<br>laboratory in vitro tests.<br>Correlation between in vitro<br>results and any clinical event has<br>not been tested. | |
| Outer (First)<br>Layer | Spun-bond Polypropylene with<br>Hydrophilic Plastic Coating | Spun-bond Polypropylene with<br>Hydrophilic Plastic Coating | Identical |
| Second Layer | Spunlace Cellulose/Polyester<br>Treated with Copper and Zinc | Spunlace Cellulose/Polyester<br>Treated with Copper and Zinc | Identical |
| Third<br>(Filtration)<br>Layer | Melt-blown Polypropylene 18 g/m² | Melt-blown Polypropylene: 18<br>g/m² | Identical |
| Inner (Fourth)<br>Layer | Spun-bond Polypropylene | Spun-bond Polypropylene | Identical |
| Fastening | Synthetic Elastic Ear Loops (not<br>made with natural rubber latex) | Synthetic Elastic Ear Loops (not<br>made with natural rubber latex) | Identical |
| Nose Strip | Malleable Aluminum Wire…