Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))

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Nov 5. 2021 Guangzhou ZhengKang Medical Equipment Co.,Ltd Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China Re: K212460 Trade/Device Name: Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 27, 2021 Received: August 5, 2021 Dear Tracy Che: 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. {1}------------------------------------------------ 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 809); 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, For 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 510(k) Number (if known) K212460 Device Name Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) Indications for Use (Describe) Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile. | 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}------------------------------------------------ # 510 (k) Summary This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92. ## (1) Applicant information | 510 (k) owner's name: | Guangzhou ZhengKang Medical Equipment Co.,Ltd | | | | |---------------------------|-----------------------------------------------------------|--|--|--| | Address: | Room101,No.9Nanling Zhongxin Kuang Road,Taihe Town,Baiyun | | | | | | District,GuangZhou,China | | | | | Contact person: | Mike Wu | | | | | Phone number: | 86-13600073056 | | | | | Fax number: | / | | | | | Email: | info@zkmedical.com | | | | | Date of summary prepared: | 2021.08.02 | | | | ## (2) Reason for the submission New device, there were no prior submissions for the device. ## (3) Proprietary name of the device | Trade name: | Medical Surgical Mask | |--------------------|---------------------------| | Regulation Name: | Surgical apparel | | Regulation number: | 21 CFR 878.4040 | | Product code | FXX | | Review panel: | General & Plastic Surgery | | Regulation class: | Class II | ## (4) Predicate device | Sponsor | Mexpo International Inc. | |-------------------|----------------------------| | Device Name | Avianz® Surgical Face Mask | | 510(k) Number | K200847 | | Product Code | FXX | | Regulation Number | 21 CFR 878.4040 | | Regulation Class | II | ## (5) Description/ Design of device Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made {4}------------------------------------------------ of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow the users to adjust the nose piece according to the shape of the bridge of the nose. ## (6) Indications for use Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile. ## (7) Materials | Component of<br>Device Requiring<br>Biocompatibility | Material of Component | Body Contact<br>Category<br>(ISO 10993-1) | Contact Duration<br>(ISO 10993-1) | |------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|-------------------------------------------|-----------------------------------| | Medical Surgical<br>Mask ( ZKM-U01<br>(non-sterilized type<br>17.5cm×9.5cm)) | Non-woven fabric,<br>Melt-blown fabric,<br>Polyester textured yarn,<br>Polyethylene | Surface-contacting<br>device: skin | > 24h to 30 d | The body-contacting material used in the Medical Surgical Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion". | Item | Proposed device | Predicate device | Remark | | |------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------|-----------------------------------------------------------------| | Trade name | Medical Surgical Mask | Avianz® Surgical Face Mask | / | | | 510 (k) number | K212460 | K200847 | / | | | Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | | Regulation description | Surgical apparel | Surgical apparel | Same | | | Product code | FXX | FXX | Same | | | Class | II | II | Same | | | Indications for use/ Intended use | Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. This is a single use device, provided non-sterile. | 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. | Similar, only wording difference | | | | | | | | | Materials | Inner layer | Non-woven fabric | Spunbond Polypropylene | Similar | | | Middle layer | Melt-blown fabric | Melt Blown<br>Polypropylene<br>Filter | Similar | | | Outer layer | Non-woven fabric | Spunbond Polypropylene | Similar | | | Nose piece | Polyethylene | Single Galvanize Wire,<br>Coated By PE | Differences resolved by<br>biocompatibility testing | | | Headband | Polyester textured yarn | Not made with natural<br>rubber latex | Differences resolved by<br>biocompatibility testing | | | Mask style | Flat pleated | Flat pleated | Same | | | Design feature | Earloop | Earloop | Same | | | Dimensions | 17.5cm×9.5cm | (17.5cm±0.5cm)×(9.0cm± 0.5cm) | Similar | | | Latex | Not made with natural<br>rubber latex | Not made with natural<br>rubber latex | Same | | Color | | Blue | White | Differences resolved by<br>biocompatibility testing | | Sterility | | Non-sterile | Non-sterile | Same | | Use | | Single use | Single use | Same | | Prescription or OTC | | OTC | OTC | Same | | ASTM F2100 Level | | Level 2 | Level 2 | Same | | | Performance test result | | | | | Fluid resistance | | No penetration pass at 120 mmHg | 30 out of 32 pass at 120 mmHg | Similar | | Particle Filtration<br>Efficiency | | Average 99.99% | 99.9% | Same | | Bacterial Filtration<br>Efficiency | | Average > 99.8% | > 99.9% | Similar | | Flammability Class | | Class 1 | Class 1 | Same | | Delta - P | | Average 5.5 mmH2O/cm² | 3.0 mmH2O/cm² | Similar, both<br>masks met<br>requirements of<br><6.0 mmH2O/cm² | | | | | | | | Biocompatibility | | No cytotoxicity (ISO 10993- 5)<br>No sensitization (ISO 10993- 10) | Non-Cytotoxic,<br>Non-Sensitizing,<br>Non-Irritating | Same | | | | | | | | | | | | | ## (8) Comparison to Predicate Device {5}------------------------------------------------ {6}------------------------------------------------ | No irritation (ISO 10993-<br>10) | | | |----------------------------------|--|--| |----------------------------------|--|--| ## (9) Non-clinical studies and tests performed The following performance tests of Medical Surgical Mask were conducted: | Test Methodology | Purpose | Acceptance criteria | Results | |--------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Fluid Resistance<br>Performance<br>ASTM F1862-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg | | Particulate Filtration<br>Efficiency ASTM<br>F2299-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | ≥98% | Pass, average 99.99% | | Bacterial Filtration<br>Efficiency<br>ASTM F2101-19 | To evaluate the bacterial filtration efficiency (BFE) of mask. | ≥98% | Pass, average > 99.8% | | Differential Pressure<br>(Delta P) EN<br>14683:2019,<br>Annex C and ASTM<br>F2100-19 | To measure the differential pressure of mask which is related to breathability. | <6.0 mmH2O/cm² | Pass, average 5.5 mmH2O/cm² | | Flammability 16<br>CFR 1610 | To evaluate the flammability of mask. | Class 1 | Pass, Class I | | In vitro cytotoxicity<br>ISO 10993-5 | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not have potential toxicity to L-929 in the MTT method. | Pass, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method. | | Skin sensitization<br>ISO 10993-10 | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of delayed dermal contact sensitization in the guinea pig. The test article Surgical face | | | | | | | Skin irritation<br>ISO 10993-10 | To evaluate the<br>biological safety of the<br>product which has<br>direct contact with<br>intact skin. | The irritation response<br>category in the rabbit<br>should be negligible. | mask has no potential<br>skin sensitization on<br>guinea pigs in the<br>extraction method. | | | | | Pass, the response of<br>the test article extract<br>was categorized as<br>negligible under the<br>test condition. The test<br>article Surgical Face<br>Mask has no potential<br>skin irritation on<br>rabbit in the extraction<br>method. | {7}------------------------------------------------ # (10) Conclusion Based on the nonclinical tests performed, the subject device, Medical Surgical Mask, is as safe, as effective, and performs as well as the legally marketed predicate device, K200847, Avianz® Surgical Face Mask.