Nordiwell Medical Face Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. December 31, 2020 Changzhou Combat Protective Equipment Co., Ltd. Yanmei Song Official Correspondent QingSiTang village, Henglin Town, Wujin District Changzhou, Jiangsu 213101 China Re: K202615 Trade/Device Name: Nordiwell Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 23, 2020 Received: November 30, 2020 Dear Yanmei Song: 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 {1}------------------------------------------------ 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 (OS) 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 mediation-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, For CAPT Elizabeth Claverie, M.S. 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 510(k) Number (if known) K202615 Device Name Nordiwell Medical Face Mask Indications for Use (Describe) When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | | Prescription Use (Part 21 CFR 801 Subpart D) |X 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}------------------------------------------------ # K202615 ### 510(k) Summary # 1. Contact Information #### 1.1. Applicant Applicant Name: Changzhou Combat Protective Equipment Co., Ltd. Address: Qingsitang, Henglin, Changzhou, Jiangsu, 213101 China Contact Person: Yanmei Song Title: Sales Manager Telephone: +86-519-85190068; +86-15051998125 E-mail: xinyaoutdoor08@126.com #### 1.2. Consultant Company: Sinow Medical AS Address: Vestre Fantoft åsen 44, 5072, Bergen, Norway Contact Person: Huifang Zhao Telephone: +86 13961151430 Email: zhao@bergemed.com ### 2. Device information Trade Name: Nordiwell Medical Face Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital # 3. Legally Marketed Primary Predicate Device Product name: _ Avianz® Surgical Face Mask 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC. {4}------------------------------------------------ ### 4. Indication for use When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. #### 5. Device Description The Nordiwell Medical Face Masks are composed of 3-layers and are flat-pleated. The mask materials consist of an outer layer (polypropylene spunbond, blue), inner layer (polypropylene spunbond white), filter (polypropylene melt-blown, white) and ear-loops. The mask contains a malleable nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face. The mask is a single use, provided non-sterile. This device is not made from Natural Rubber Latex. Shelf-life of the device is 2 years. | Device | Subject Device (K202615)<br>Nordiwell Medical Face<br>Mask,<br>Model 952001 | Predicate Device (K200847)<br>Avianz® Surgical Face Mask | Comparison | |-------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Intend use | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | Same | | Material | | | | | Outer Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | | Filter(Middle layer) | Melt Blown Polypropylene<br>Filter | Melt Blown Polypropylene Filter | Same | | Inner Layer | Spunbond Polypropylene | Spunbond Polypropylene | Same | | Nose Wire | Single Galvanize Wire, Coated | Single Galvanize Wire, Coated | Similar | | | by Polypropylene | by PE | | | Ear Loops | Spandex and Nylon, natural<br>rubber latex free | Not made with natural rubber<br>latex | Same | | | Design Features | | | | Colors | Blue | White | Different | | Style | Flat - Pleated | Flat - Pleated | Same | | Multiple<br>Layers | Yes | Yes | Same | | Single Use | Yes | Yes | Same | | OTC Use | Yes | Yes | Same | | | Sterility | | | | Sterile | Non-Sterile | Non-Sterile | Same | | | Dimension | | | | Length | 17.5cm ±0.5cm | 17.5cm ±0.5cm | Same | | Width | 9.5cm ±0.5cm | 9.0cm ±0.5cm | Similar | | | Performance | | | | Fluid Resistance Performance<br>ASTM F1862 | 32 of 32 pass at 160 mmHg | 30 Out of 32 pass at 120 mmHg | Better | | Particulate Filtration Efficiency<br>ASTM F2299 | > 99.9% | 99.9% | Same | | Bacterial Filtration Efficiency<br>ASTM F2101 | > 99.9% | ≥98% | Better | | Differential Pressure<br>(Delta P) | 5.6 mmH20/cm²<br>( EN 14683:2019, Annex C<br>and ASTM F2100-19) | 3.0 mmH20/cm²<br>(MILM-36954C) | Similar | | Flammability 16 CFR 1610 | Class 1 | Class 1 | Same | | | Biocompatibility | | | | In Vitro Cytotoxicity Test<br>ISO 10993-5: 2009 | Non-Cytotoxic | Non-Cytotoxic | Same | | Skin Irritation Test<br>ISO 10993-10:2010 | Non-Irritating | Non-Irritating | Same | | Skin Sensitization Test<br>ISO 10993-10:2010 | Non-Sensitizing | Non-Sensitizing | Same | # 6. Substantially Equivalent (SE) Comparison {5}------------------------------------------------ # 7. Non-Clinical Test Non clinical tests were conducted to verify that the proposed device met all design {6}------------------------------------------------ specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards: (1) Performance test: Bench test was conducted on Medical Face Mask for proposed device to determine substantially equivalence. The bench tests include the following tests: | Item | Proposed Device | Acceptance Criteria | Result | |------------------------------------------------------------------------------------|---------------------------|----------------------------|--------| | Fluid Resistance Performance<br>ASTM F1862-17 | 32 of 32 pass at 160 mmHg | ≥29 of 32 pass at 160 mmHg | Pass | | Particulate Filtration<br>Efficiency ASTM F2299-17 | > 99.9% | ≥ 98% | Pass | | Bacterial Filtration Efficiency<br>ASTM F2101-19 | > 99.9% | ≥ 98% | Pass | | Differential Pressure<br>(Delta P) EN 14683:2019,<br>Annex C and ASTM<br>F2100-19. | 5.6 mmH20/cm² | <6.0 mmH20/cm² | Pass | | Flammability 16 CFR 1610 | Class 1 | Class 1 | Pass | (2) Biocompatibility evaluation and test Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance and ISO10993-1:2018 supports that the subject devices are biocompatible. The biocompatibility test includes the following tests: In Vitro Cytotoxicity Test(ISO 10993-5: 2009) Skin Irritation Test(ISO 10993-10:2010) Skin Sensitization Test(ISO 10993-10:2010) (3) Shelf-life accelerated aging test The accelerated aging tests were conducted with 3 non-consecutive lots. The following performances were tested both for before and after aged products: Fluid Resistance Performance according to ASTM F1862-17. Particulate Filtration Efficiency according to ASTM F2299-17. Bacterial Filtration Efficiency according to ASTM F2101-19. Differential Pressure (Delta P) according to EN 14683:2019, Annex C and ASTM F2100-19. Flammability according to 16 CFR 1610. ### 8. Clinical Test Conclusion {7}------------------------------------------------ No clinical study is included in this submission. # 9. Conclusion The summary includes the conclusions drawn from the nonclinical and clinical tests (discussed above) that demonstrate that the device is as safe, as effective, and performs as well as or better than the predicate device.