DEFEND Ear-loop Face Masks

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April 14, 2021 Young Dental Manufacturing Co. 1, LLC Jose Espino, Official Correspondent 13705 Shoreline Court East Earth City, Missouri 63045 Re: K201127 Trade/Device Name: DEFEND Ear-loop Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 6, 2021 Received: April 8, 2021 Dear Jose Espino: 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). Sincerelv. Ryan Ortega -S Ryan Ortega, PhD. Acting Assistant Director 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201127 Device Name DEFEND Ear-loop Face Masks ### Indications for Use (Describe) DEFEND Ear-loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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. Level 3 Model: MK-7300 | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|-----------------------------------------| | Prescription Use (Part 21 CFR 801 Subpart D) | | | Over-The-Counter Use (21 CFR 801 Subpart C) | <span style="font-size: 20px;">☑</span> | ### 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}------------------------------------------------ ### Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks # 510(k) Summary As required by the Safe Medical Devices Act (SMDA) of 1990 and in accordance with 21 CFR § 807.93, 510(k) summary is provided. DATE: April 2, 2021 ## 510(k) NUMBER: K201127 #### . SUBMITTER Young Dental Manufacturing Co 1, LLC. 13705 Shoreline Ct. E. Earth City, MO 63045 Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com #### ll. OFFICIAL CORRESPONDENCE/CONTACT PERSON Jose Espino 13705 Shoreline Ct. E. Earth City, MO 63045 Tel: 847-458-5829 ext. 2829 Email: jespino@younginnovations.com #### = 510(K) PREPARER Brian Prange 13705 Shoreline Ct. E. Earth City, MO 63045 Tel: 314-372-8054 Email: bprange@younginnovations.com ## IV. DEVICE Brand Name of Device: DEFEND Ear-Loop Face Masks Common or Usual Name: Surgical Mask Classification Name: Mask, Surqical Regulation: 21 CFR 872.4040 Device Classification: Class: II {4}------------------------------------------------ Product Code: FXX # V. PREDICATE DEVICE Trade Name: Surgical Masks (Ear loop and Tie-on) Common Name: Surgical Mask 510(k) Number: K160269 (Decision Date: September 6, 2016) Manufacturer: San-M Package Co., LTD. # VI. DEVICE DESCRIPTION The DEFEND Ear-Loop Face Masks are comprised of four layers of nonwoven materials ultrasonically welded together along the edges with ear loops ultrasonically welded to the sides. The four layers include an outer layer (faces outward when worn), filtration layer, middle layer, and inner layer (faces the user). The materials used in this mask meet the performance requirements for Level 3 stated in ASTM F2100 -19 Performance of Materials Used in Medical Face Masks. The mask is secured to the face with ear loops. The mask also includes a form-fitting pliable nose piece to improve fit and reduce gaps for maximum protection. The DEFEND Ear-Loop Face Masks will be available in ASTM Level 3 in blue. Table 1 lists the Model number of the masks that will be available. | Table 1. DEFEND Ear-Loop Face Masks Model Number | | | |--------------------------------------------------|------------|-------| | Model Number | ASTM Level | Color | | MK-7300 | Level 3 | Blue | Table 1, DEEEND Ear-Loop Eace Masks Model Number #### VII. INDICATIONS FOR USE The DEFEND Ear-Loop Face Masks are intended to be worn to protect both the patient and healthcare professional 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. {5}------------------------------------------------ ## Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks #### VIII. SUBSTANTIAL EQUIVALENCE (SE) COMPARISON | Product Comparison - Similarities and Differences | | | | | |-----------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|---------| | Characteristic | Proposed Device | San-M Package Co.,<br>LTD., Surgical Face<br>Masks (Ear loops<br>and Tie-on) | Results | | | Manufacturer | Young Innovations | San-M Package Co.,<br>Ltd. | | | | 510(k) Number | K201127 | K160269 | | | | Class | Class II | Class II | Same | | | Regulation Number | 21 CFR 872.4040 | 21 CFR 872.4040 | Same | | | Intended Use / Indications for<br>Use | The DEFEND Ear-<br>Loop Face Masks are<br>intended to be worn<br>to protect both the<br>patient and<br>healthcare<br>professional from<br>transfer of<br>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<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single use,<br>disposable device,<br>provided non-sterile. | The surgical face<br>masks are intended<br>to be worn to<br>protect both the<br>patient and<br>healthcare personnel<br>from transfer of<br>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<br>the potential<br>exposure to blood<br>and body fluids. This<br>is a single-use,<br>disposable device,<br>provided non-sterile. | Same | | | Product Code | FXX | FXX | Same | | | Use | OTC | OTC | Same | | | Length of Main body | 175 mm ± 5 mm | 175 mm ± 5 mm or<br>180 mm ± 5 mm | Same | | | Width of Main body | 95 mm ± 5 mm | 90 mm ± 5 mm | Similar | | | Mask Style | Flat-pleated | Flat-Pleated | Same | | | Sterility | Non-Sterile | Non-Sterile | Same | | | Single Use | Yes | Yes | Same | | | Colors | Blue | White or Blue | Similar | | | Outer Material | Spunbond<br>Polypropylene | Polypropylene | Polypropylene | Same | | Filter Material | Meltblown<br>Polypropylene<br>Fluid Resistant<br>Polypropylene Film-<br>Blue | Polypropylene | Polypropylene<br>spunbond<br>Polypropylene<br>meltblown | Same | | Inner Material | Spunbond<br>Polypropylene | Polyethylene | Polyethylene | Similar | | Ear loops | Polyester | Polyester | Polyester,<br>polyurethane | Same | | Nose piece | | Steel wire | Polyethylene coated<br>steel wire | Similar | | Performance Testing (ASTM<br>F2100-11) | | | | | | Fluid Resistance<br>(ASTM F1862) | Level 3 (@ 160<br>mmHg) | Pass @ 160 mmHg | Pass at 160 mmHg | Same | | Particulate<br>Filtration<br>Efficiency<br>(ASTM F2299) | Level 3 (≥ 98%) | Pass @ 99.5% | Pass at 99.7% | Same | | Bacterial<br>Filtration<br>Efficiency<br>(ASTM F2101) | Level 3 (≥ 98%) | Pass @ > 99% | Pass at > 99% | Same | | Differential<br>Pressure (EN<br>14683:2019,<br>Annex C and<br>MIL-M-36954C) | Level 3 (< 6.0) | Pass @ 3.4-4.0 | Pass at 2.5<br>mmH2O/cm² | Same | | Flammability<br>(16 CFR 1610) | Level 3 (Class<br>1) | Class 1 | Class 1 | Same | | Cytotoxicity<br>ISO 10993-5 | | Under the conditions<br>of the study, the<br>subject device was<br>non-cytotoxic. | Under the conditions<br>of the study the<br>subject device was<br>non-cytotoxic. | Same | | Irritation<br>ISO 10993-10 | | Under the conditions<br>of the study, the<br>subject device was<br>non-irritating. | Under the conditions<br>of the study, the<br>subject device was<br>non-irritating. | Same | | Sensitization<br>ISO 10993-10 | | Under the conditions<br>of the study, the<br>subject device was | Under the conditions<br>of the study, the<br>subject device was | Same | ### Table 2. Device Comparison (Similarities and Differences) {6}------------------------------------------------ ## Young Dental Manufacturing Co. | Premarket Notification 510(k) K201127 Submission Under 21 CFR § 807.87 for DEFEND Ear-Loop Masks {7}------------------------------------------------ As indicated in Table 2, all relevant comparison items are very similar, and do not exhibit any changes that would impact intended use or the user experience. # IX. SUMMARY OF NON-CLINICAL PERFORMANCE DATA The DEFEND Ear-Loop Face Masks have been tested according to the Guidance for Industry and FDA Staff: Surgical Masks-Premarket Notifications [510(k)] Submissions, issued March 5, 2004. This includes performance testing according to ASTM F2100. See Table 3 for a testing summary. | Methodology | Purpose | Acceptance<br>Criteria (AQL =<br>4.0%) | Results | |----------------------------------------|---------------------------------------------------------------|----------------------------------------|---------------------------------------------| | ASTM F1862 | Determine synthetic<br>blood penetration<br>resistance | 29/32 pass at 160<br>mmHg | 32/32 Pass per lot at<br>160 mmHg | | ASTM F2101 | Determine the<br>bacterial filtration<br>efficiency | ≥ 98% | 32/32 Pass per lot,<br>Average = 99.8% | | ASTM F2299 | Determine sub-<br>micron particulate<br>filtration efficiency | ≥ 98% | 32/32 Pass per lot,<br>Average = 99.7% | | MIL-M-36954C or<br>EN 14683 Annex<br>C | Determine breathing<br>resistance or<br>differential pressure | < 6.0 mm H2O/cm2 | 32/32 Pass per lot, 3.4<br>- 4.0 mm H20/cm2 | | 16 CFR Part 1610 | Determine<br>flammability or<br>flame spread | Class 1 | Class 1 | Table 3. Summary of ASTM F2100 Testing All results of testing met ASTM F2100 acceptance criteria. # X. Summary of Clinical Testing No clinical study is included in this submission # XI. CONCLUSIONS The conclusions drawn from nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.