Disposable Medical Face Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. November 5, 2021 Zhejiang Senhong Medical&Instrument Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China Re: K202676 Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 20, 2021 Received: October 5, 2021 Dear Boyle Wang: 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 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) K202676 Device Name Disposable Medical Face Mask #### Indications for Use (Describe) The Disposable Medical Face 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(s), 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 (K202676) This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92. ### 1.0 Submitter's Information Name: Zhejiang Senhong Medical&Instrument Co., Ltd. Address: Floor 1-2, Building 2, No 889 North Huancheng Rd, Fu'xi Subdistrict, Deqing County, Huzhou, Zhejiang, 313200, China Tel: 86-18006712375 Contact: Eric Jian Date of Preparation: Nov.3,2021 #### Designated Submission Correspondent Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn ### 2.0 Device Information | Trade name: | Disposable Medical Face Mask | |--------------|-----------------------------------| | Common name: | Surgical Face Mask Classification | | name: | Surgical Face Mask | ### 3.0 Classification | Production code: | FXX | |--------------------|------------------| | Regulation number: | 21CFR 878.4040 | | Classification: | Class II | | Panel: | Surgical Apparel | #### 4.0 Predicate Device Information | Manufacturer: | WUHAN DYMEX HEALTHCARE CO., LTD. | |----------------|----------------------------------| | Device: | SURGICAL FACE MASK | | 510(k) number: | K182515 | {4}------------------------------------------------ ### 5.0 Device Description The Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices. ### 6.0 Indication for Use Statement The Disposable Medical Face 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(s), provided non-sterile. | Item | Subject Device<br>K202676 | Predicate Device<br>K182515 | Remark | |--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------| | Product Name | Disposable Medical Face<br>Mask | Surgical Face Mask | -- | | Product Code | FXX | FXX | Same | | Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | | Class | II | II | Same | | Intended Use&<br>Indications for use | The Disposable Medical Face<br>Mask is intended to be worn<br>to protect both the patient<br>and healthcare personnel<br>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<br>is a single use, disposable<br>device(s), provided non-<br>sterile. | The Surgical Face<br>Masks are intended to be<br>worn to protect both the<br>patient and healthcare<br>personnel from transfer<br>of microorganisms, body<br>fluids and particulate<br>material. These face<br>masks are intended for<br>use in 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(s),<br>provided non-sterile. | Same | #### Table 1 General Comparison 7.0 Technological Characteristics Comparison to the Predicate Device {5}------------------------------------------------ | Design features | | | | | |-----------------|---------------------|------------------------------------|------------------------------------|------------| | Mask Styles | Ear Loops, 3 layers | Ear Loops, 3 layers | Same | | | | Flat pleated | Flat pleated | Same | | | Material | Outer facing layer | Nonwoven fabrics | Spun-bond polypropylene | Same | | | Middle layer | Melt blown fabrics | Melt blown polypropylene filter | Same | | | Inner Facing layer | Nonwoven fabrics | Spun-bond polypropylene | Same | | | Nose piece | Galvanized iron wire | Malleable polyethylene wire | Different* | | | Ear loops | not made with natural rubber latex | not made with natural rubber latex | Same | | | Color | Blue | Blue | Same | | | Dimension (Length) | 17.5 cm +/- 1cm | 17.5 cm +/- 1cm | Same | | | Dimension (Width) | 9.5 cm +/- 1cm | 9.5 cm +/- 1cm | Same | | | OTC use | Yes | Yes | Same | | | Sterility | Non-Sterile | Non-Sterile | Same | | | Single Use | Yes | Yes | Same | | | Sterile | No | No | Same | | | ASTM F2100 Level | Level 2 | Level 2 | Same | *The difference in the materials does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials. # 8.0 Non-Clinical Test Conclusion The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004. ### Table 2 - Performance Testing {6}------------------------------------------------ | Test<br>Methodology | Purpose | Acceptance<br>Criteria | Result | |-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Resistance<br>penetration<br>synthetic blood | to Determine synthetic<br>byblood penetration<br>resistance as specified<br>in Test<br>Method F1862 | 29 Out of 32 pass<br>at 120 mmHg | Lot 1:<br>31 out of 32 pass at<br>120mmHg<br>Lot 2:<br>31 out of 32 pass at<br>120mmHg<br>Lot 3:<br>32 pass at 120mmHg<br>Pass | | Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | Determine particulate<br>filtration efficiency as<br>directed in Test Method<br>F2299. | ≥ 98% | Lot 1: average 99.23%<br>Lot 2: average 99.29%<br>Lot 3: average 99.29%<br>Pass | | Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | Determine the bacterial<br>filtration efficiency as<br>directed in Test Method<br>ASTM F2101. | ≥ 98% | Lot 1: average 99.75%<br>Lot 2: average 99.79%<br>Lot 3: average 99.75%<br>Pass | | Differential<br>Pressure<br>(Delta - P) | Determine<br>breathing<br>resistance or differential<br>pressure as directed in<br>EN 14683:2019, Annex<br>C. | < 6.0<br>mmH₂0/cm² | Lot 1:<br>average 4.07 mm H₂0/cm²<br>Lot 2:<br>average 4.07 mm H₂0/cm²<br>Lot 3:<br>average 4.13 mm H₂0/cm²<br>Pass | | Flammability<br>16 CFR 1610 | Determine flammability<br>as specified in 16 CFR<br>Part 1610 | Class 1<br>(Burn time<br>≥3.5 s, IBE, or<br>DNI) | Lot 1: Class 1<br>Lot 2: Class 1<br>Lot 3: Class 1<br>Pass | # Table 3 - Biocompatibility Testing | Test Methodology | Purpose | Acceptance Criteria | Result | |------------------|--------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------| | Cytotoxicity | Determine the effects<br>on cells following ISO<br>10993-5 | The test article should not<br>have potential toxicity to<br>L-929 in the MTT<br>method. | Pass under the conditions<br>of the study, the device is<br>noncytotoxic. | | Irritation | Estimate the potential<br>for contact<br>sensitization following<br>ISO 10993-10 | The irritation response<br>category in the rabbit<br>should be negligible. | Pass under the conditions<br>of the study, the device is<br>nonirritating. | | Sensitization | Estimate the irritation<br>potential of medical<br>device following ISO<br>10993- 10 | The test article should not<br>cause delayed dermal<br>contact sensitization in the<br>guinea pig. | Pass under the conditions<br>of the study, the device is<br>nonsensitizing. | {7}------------------------------------------------ # 9.0 Clinical Test Conclusion No clinical study is included in this submission. #### 10.0 Conclusion The conclusion drawn from the non-clinical tests demonstrates that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device in K182515.