Surgical Mask-Model Number CW01

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services-USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's mission to protect and promote public health through the regulation and supervision of food safety, tobacco, pharmaceuticals, medical devices, and other related products. September 8, 2020 Hunan Heng Chang Pharmaceutical Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza, West Guangzhong Road 555, Jingan Shanghai. 200071 China Re: K202354 Trade/Device Name: Surgical Mask-Model Number CW01 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2020 Received: August 19, 2020 Dear Shelley Li: 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 {1}------------------------------------------------ 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For CAPT Elizabeth Claverie, M.S. 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) K202354 Device Name Surgical Mask Indications for Use (Describe) The Surgical Masks are 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(s), provided non-sterile/ sterile. Type of Use (Select one or both, as applicable) | <input type="checkbox"/> Registration Use (Part 21 CFR 201.2 Subject to Review) | <input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 201.2 Subject to Review) | |---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| |---------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------| _ | 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: K202354 #### I Submitter Hunan Heng Chang Pharmaceutical Co., Ltd. Floor 2, 3, 102 of Building 16, Standard Plant of Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Kaifu District, Changsha 410000, China Contact person: Tao Jingfeng Position: QC Manager Tel.: ++86-18774961605 E-mail: taojingfeng@hcyy.com Preparation date: Aug. 27, 2020 ### II Proposed Device | Trade Name of Device: | Surgical Mask | |-----------------------|------------------| | Common name: | Surgical Mask | | Regulation Number: | 21 CFR 878.4040 | | Regulatory Class: | Class II | | Product code: | FXX | | Review Panel: | General Hospital | | 510(k) Number: | K202354 | ### III Predicate Devices | 510(k) Number: | K153496 | |-----------------|-----------------------------------------| | Trade name: | Disposable Surgical Face Mask | | Common name: | Surgical Mask | | Classification: | Class II | | Product Code: | FXX | | Manufacturer | Xiantao Rayxin Medical Product Co., Ltd | ### IV Device description The Surgical Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Face Masks are manufactured with three layers. The outer layer is made of spunbonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer 1 {4}------------------------------------------------ contact with face is made of polypropylene (PP) fabric. The Surgical Masks are single use, disposable device, provided non-sterile/sterile. ## V Indication for use The Surgical Masks are 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(s), provided non-sterile/sterile. | Item | Proposed device<br>(K202354) | Predicate device<br>(K153496) | |--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Product name | Surgical Mask | Disposable Surgical Face<br>Mask | | Product Code | FXX | FXX | | Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | | Class | Class II | Class II | | Mask style | Flat-pleated, ear loop, 3<br>layers | Flat-pleated, ear loop, tie-on,<br>3 layers | | Indication for use | The Surgical Masks are<br>intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms,<br>body fluids and particulate<br>material. These face masks<br>are intended for use in<br>infection control practices to<br>reduce the potential<br>exposure to blood and body<br>fluids. This is a single use,<br>disposable device(s),<br>provided non-sterile/ sterile. | The Disposable Surgical<br>Face Masks are intended to<br>be worn to protect both the<br>Patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids<br>and particulate material.<br>These face masks are<br>intended for use in infection<br>control practices to reduce<br>the potential exposure to<br>blood and body fluids. This is<br>a single use, disposable<br>device(s), provided non-<br>sterile. | | Material | Inner<br>Spun-bond polypropylene | Spun-bond polypropylene | #### VI Comparison of technological characteristics with the predicate devices {5}------------------------------------------------ | | layer | | | |----------------------|--------------|-----------------------------------------------------------|-----------------------------------------------------------| | | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | | | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | | | Ear loop | Spandex + Polyester | Polyester | | | Nose piece | malleable polyethylene | Malleable aluminum wire | | Color | | Blue | blue | | Length | | $17.5 cm±5%$ | $17.5±1cm$ | | Width | | $9.5 cm±5%$ | $9.5±1cm$ | | OTC use | | Yes | Yes | | sterile | | Non-sterile, sterile | Non-sterile | | Sterilization method | | EO | / | | Single for use | | Yes | Yes | | ASTM F2100 Level | | Level 1 | Level 2 | | Biocompatibility | | Confirm to the requirements of ISO 10993 series standards | Confirm to the requirements of ISO 10993 series standards | # VII Summary of Non-Clinical Testing Non clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the following standards: | Methodology | Purpose | Acceptance Criteria | Results | |--------------------|--------------------------------------|---------------------------------|---------------------------------| | ASTM F1862M-<br>17 | Fluid Resistance<br>Performance | 29 out of 32 pass<br>at 120mmHg | 32 out of 32 pass<br>at 120mmHg | | ASTM F2299 | Particulate Filtration<br>Efficiency | ≥95% | 95.8~96.8% | | ASTM F2101-19 | Bacterial Filtration<br>Efficiency | ≥95% | 98.3~99.2% | {6}------------------------------------------------ | EN 14683:2019<br>Annex C | Differential<br>Pressure | < 5.0mmH2O/cm² | 3.7~3.8<br>mmH2O/cm² | |--------------------------|--------------------------|-----------------------|----------------------| | 16 CFR 1610 | Flammability | Class I non flammable | non flammable | - ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For ● In Vitro Cvtotoxicity - ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests For . Irritation And Skin Sensitization. - ASTM F2100-19, Standard Specification for Performance of Materials Used In . Medical Face Masks. - ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face Masks . To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity) - EN 14683:2019, Medical Face Mask-Test-Requirements and TestMethods; ● - ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration ● Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus; - ASTM F2299-03, Stand test method for determining the initial efficiency of . materials used in medical face masks to penetration by particulates using latex spheres: - 16 CFR 1610, Standard for the Flammability of clothing textiles; ● # VIII Summary of Clinical Testing No clinical study is included in this submission. ### IX Conclusion The conclusion drawn from the non-clinical performance testing data demonstrates that the subject device is as safe, as effective, and performs as well as or better than the predicate device, Disposable Surgical Face Mask (K153496).