Heartland Health Surgical Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text. February 19, 2022 Heartland Health Products Frank Fischer Chief Operating Officer 5389 East Provident Dr Cincinnati, Ohio 45246 Re: K212366 Trade/Device Name: Heartland Health Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 25, 2022 Received: January 25, 2022 # Dear Frank Fischer: 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 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use Device Name Heartland Health Surgical Mask #### Indications for Use (Describe) The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided nonsterile. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------| | <span style="display:inline-block;"><input type="checkbox"/></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="display:inline-block;"><input checked="" type="checkbox"/></span> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(k) Summary ## Date of Summary Prepared: 01/21/2022 | 510(k) Number: | K212366 | |----------------------|------------------------------------------------| | Submitted by: | | | Company Name: | Heartland Health Products | | Company Address: | 5389 East Provident Dr<br>Cincinnati, OH 45246 | | Contact Person: | Frank Fischer, Chief Operating Officer | | Phone: | 513-870-1611 | | Email: | ffischer@heartlandhealthproducts.com | | Correspondent: | Doug Keefe, Quality/Regulatory Manager | | Correspondent Phone: | 513-870-1611 | | Correspondent Email: | dougkeefe@heartlandhealthproducts.com | ### Regulatory Information: | Trade Name: | Heartland Health Surgical Mask | |-----------------------|--------------------------------| | Common/Usual Name: | Surgical mask | | Product Code: | FXX | | Regulation Number: | 21 CFR 878.4040 | | Device Class: | Class II | | Reviewing Panel: | General Hospital | | Basis for Submission: | New device abbreviated 510(k) | #### Predicate Device: | 510(k) Number: | K131879 | |----------------|-----------------| | 510(k) Holder: | Kimberly-Clark* | | Device Name: | Surgical mask | ## Indications for Use: The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. ## Device Description: The surgical mask is a three-layer, flat pleated facepiece composed of a spunbond outer layer, filter layer, and spunbond (skin-contacting) inner layer. The mask is held in place with an elastic headband, and the position of the mask on the face is maintained with a nose wire and elastic beneath the chin. It is supplied non-sterile and is a single-use disposable. {4}------------------------------------------------ | Table 1. Predicate<br>Comparison<br>Description | Subject Device | Predicate (K131879) | Comparison | |-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Indication for Use | The surgical mask is<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids, and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single-use,<br>disposable device,<br>provided non-sterile. | The Kimberly-Clark<br>KC300 Face Mask is<br>intended to be worn to<br>protect both the patient<br>and healthcare<br>personnel from transfer<br>of microorganisms,<br>body fluids, and<br>particulate material.<br>These face masks are<br>intended for use in<br>infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single-use,<br>disposable device,<br>provided non-sterile. | Same | | Environment of Use | OTC | OTC | Same | | Sterility | Non-sterile | Non-sterile | Same | | Use | Single-use, disposable | Single-use, disposable | Same | | Anatomical site | Nose and mouth | Nose and mouth | Same | | Target Population | Adults | Adults | Same | | Design Features | | | | | Mask style | Flat-pleated | Flat-pleated | Same | | Design | Headband | Ear loops, tie strings | Different, but no new<br>issues of safety or<br>efficacy | | Materials | | | | | Outer facing layer | Polypropylene<br>spunbond | Polyethylene/polyester<br>with pink and blue ink | Similar, both met<br>performance and<br>biocompatibility<br>requirements | | Middle layer | Polypropylene | Polypropylene<br>spunbond,<br>polypropylene<br>meltblown | Same | | Inner facing layer | Polypropylene<br>spunbond | Polyethylene/polyester | Similar, both met<br>performance and<br>biocompatibility<br>requirements | | Table 1. Predicate<br>Comparison<br>Description | Subject Device | Predicate (K131879) | Comparison | | Chin elastic | Lycra | N/A | Different. both<br>met performance and<br>biocompatibility<br>requirements | | Nose piece | Polyethylene and soft<br>annealed carbon steel | Unknown | Similar. both met<br>performance and<br>biocompatibility<br>requirements | | Headband materials | Spunbond<br>polypropylene, spandex<br>with blue ink | Polyester/Lycra knitted | Similar, both met<br>performance and<br>biocompatibility<br>requirements | | Colorants | Aquaking Pro Cyan<br>(headband) | Markem Ink<br>(facepiece) | Different, both met<br>biocompatibility<br>requirements | | Specifications and Dimensions | | | | | Layers | Three | Multiple | Similar | | Dimension (length) | 241 ± 7mm (9.5" ± .28")<br>(small)<br>279 ± 7mm (11" ± .28")<br>(large) | 6.5" ± 0.75" | Different, but no new<br>issues of safety or<br>efficacy | | Dimension (width) | 105 ± 6 mm (3.7" ±<br>0.24") (small and large) | 4" ± 0.75" | Similar, but no new<br>issues of safety or<br>efficacy | | Color | white (facepiece)<br>blue (headband) | Pink and blue<br>(facepiece) | Different, both met<br>biocompatibility<br>requirements | | Testing | | | | | NIOSH Certification<br>number | N/A | N/A | Same | | ASTM F2100-19<br>Level | Level 3 | Level 3 | Same | | Biocompatibility (ISO<br>10993) | Non-cytotoxic, Non-<br>sensitizing, Non-<br>irritating | Non-cytotoxic, Non-<br>sensitizing, Non-<br>irritating | Same | | Test Methodology | Purpose | Acceptance Criteria | Results | | ASTM F1862:2017-<br>Fluid Resistance<br>Performance | Evaluate the resistance of medical<br>face masks to penetration by the<br>impact of a small volume (~2 mL) of<br>a high-velocity stream of synthetic<br>blood. | Class 3 - pass at<br>160mmHg<br>Class 2 - pass at<br>120mmHg<br>Class 1- pass at 80mmHg | Pass | | ASTM F2299:2017 -<br>Particulate Filtration<br>Efficiency | Evaluate filtration efficiency by<br>comparing the particle count in the<br>feed stream (upstream) to that in<br>the filtrate (downstream) for the<br>materials used in medical face<br>masks | >98% | Pass | | ASTM F2101:2019 -<br>Bacterial Filtration<br>Efficiency | Evaluate the effectiveness of<br>medical face mask materials in<br>preventing the passage of<br>aerosolized bacteria, expressed in<br>the percentage of a known quantity<br>that does not pass the medical face<br>mask material at a given aerosol<br>flow rate. | >98% | Pass | | EN 14683:2019 -<br>Differential<br>Pressure | Evaluate the resistance to air flow<br>and breathability of a medical face<br>mask by measuring differential<br>pressure through the materials of a<br>mask | < 6.0mmH2O/cm² | Pass | | 16 CFR 1610 -<br>Flammability | Evaluate the resistance of a mask<br>to ignition when exposed to a flame | Class 1 | Pass | | ISO 10993-5:2009,<br>Cytotoxicity | Evaluate the potential of a<br>medical device to cause<br>cytotoxic reactions in<br>mammalian cell culture | Under the conditions of the<br>study, the predicate device<br>extract was determined to<br>be non-cytotoxic | Pass | | ISO 10993-10:<br>2021, Irritation | Evaluate the potential of a<br>medical device to cause skin<br>irritation | Under the conditions of the<br>study, the predicate device<br>non-polar and polar<br>extracts were determined<br>to be non- irritating. | Pass | # Summary of Comparison and Technological Characteristics {5}------------------------------------------------ {6}------------------------------------------------ Non-clinical testing was conducted in accordance with FDA's "Guidance for Industry and FDA Staff Surgical Masks – Premarket Notification [510(k)] Submission," issued March 5, 2004. A summary of performance testing, including references to recognized standards, is provided below in Table 2. Table 2: Summary of Non-Clinical Testing {7}------------------------------------------------ {8}------------------------------------------------ # Conclusion The conclusion drawn from the nonclinical tests demonstrates that the proposed device in 510(K) submission K212366, Heartland Health Surgical Mask is as safe, as effective and performs as well as or better than the legally marketed predicate device (K131879), Kimberly-Clark KC300 Face Mask.