Surgical mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. August 18, 2021 Jiangsu Xingtong Biotechnology Group Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China Re: K211454 Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 6, 2021 Received: July 12, 2021 Dear James Tsai: 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 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 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 Clarence W. Murray, III, Ph.D. 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) K211454 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, and provided as sterile. Level 3 Surgical mask model (Ear-loop): XT10A1 Level 3 Surgical mask model (Tie-on): XT10B1 | 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 #### K211454 ### 1. Administrative Information | Date of Summary prepared | August 5, 2021 | |--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Manufacturer information | Company: Jiangsu Xingtong Biotechnology Group<br>Co., Ltd. | | | Company address:<br>No.8, Kele road, Touqiao Area, Beizhou Industrial<br>Park, Guangling Zone, Yangzhou City, China<br>Contact person: Li Hua<br>Tel: +86-0514-87485222 | | | Fax: +86-0514-87481010 | | | E-mail: 920740335@qq.com | | Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.<br>Address: 1713A, 17th Floor, Block A, Zhongguan<br>Times Square, Nanshan District, Shenzhen<br>Contact person: James Tsai<br>E-Mail: james tsai@cefda.com; field@cefda.com | # 2. Device Information | Type of 510(k) submission: | Traditional | |----------------------------|-------------------------------------| | Trade Name: | Surgical mask | | Classification name: | Surgical Face Mask, Apparel | | Review Panel: | General and plastic surgery devices | | Product Code: | FXX | | Common name | Surgical mask | | Device Class: | II | | Regulation Number: | 878.4040 | # 3. Predicate Device Information | Sponsor: | SAN-M PACKAGE CO., LTD. | |--------------------|-------------------------------------------| | Device trade name: | Surgical face mask (Ear loops and Tie-on) | | Device Class: | II | | 510(K) Number: | K160269 | {4}------------------------------------------------ | Regulation name | Masks, Surgical | |------------------------|------------------------------------| | Production regulation: | 21 CFR §878.4040 | | Product code: | FXX | | Review Panel: | General and plastic surgery device | ### 4. Device Descriptions The surgical mask consists of a mask body, a nose piece, and ear loops or ties. The mask body is divided into three layers, the inner and outer layers are made of polypropylene materials; the middle layer is composed of melt-blown cloth (polypropylene); the nose piece is made of polyethylene coated steel wire, the ear loops are made of polyester silk & polyurethane filament, and the ties are made of polypropylene. The size specification of the surgical mask: - Mask body for ear-loop type: 17.5cm×9.5cm & 14.5cm×9.5cm; - Mask body for Tie-on type: 17.5cm×9.5cm ### 5. Indications 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, provided as sterile. # 6. Technological Characteristics Comparison | Comparison<br>item | Proposed Device<br>(Jiangsu Xingtong<br>Biotechnology Group Co.,<br>Ltd.) | Predicate Device<br>(K160269, SAN-M<br>PACKAGE CO., LTD.) | Remark | |---------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------| | Product name | Surgical mask | Surgical face mask | Similar | | Product model | Ear loops: XT10A1;<br>Tie-on: XT10B1 | Ear loops: EL 30000;<br>Tie-on: TO 30000 | Similar | | Product Code | FXX | FXX | Same | | Classification | Class II (21 CFR<br>878.4040) | Class II (21 CFR<br>878.4040) | Same | | Intended<br>use &<br>Indications for<br>Use | The surgical masks are<br>intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids. and particulate | The surgical face masks<br>are intended to be worn to<br>protect both the patient<br>and healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids. and particulate | Similar | | | | | | | | material. These face<br>masks are intended for use<br>in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable<br>device, provided as sterile. | material. These face<br>masks are intended for use<br>in infection control<br>practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable<br>device, provided non-<br>sterile. | | | Mask features | Ear Loops and Tie-on;<br>Flat Pleated | Ear Loops and Tie-on;<br>Flat Pleated | Same | | Layers | 3 layers | 4 layers | Different | | Outer layer | Polypropylene | Polypropylene | Same | | Filter media | Melt-blown cloth<br>(polypropylene) | Polypropylene spunbond<br>Polypropylene meltblown | Different | | Inner layer | Polypropylene | Polypropylene | Same | | Ear loops | -Ear loops: Polyester silk &<br>Polyurethane filament<br>-Ties: Polypropylene | -Ear loops: Polyester,<br>polyurethane<br>-Side tapes: Polyester<br>spunbond (ear loops mask<br>only)<br>-Tie tapes: Polypropylene<br>spunbond or polyester<br>spunbond | Similar | | Nose piece | Polyethylene coated<br>steel wire | Polyethylene coated<br>steel wire | Same | | Color | Blue | White or Blue | Similar | | Dimension | Mask body for ear-loop<br>type: 17.5cm×9.5cm &<br>14.5cm×9.5cm<br>Mask body for Tie-on type:<br>17.5cm×9.5cm | Mask body for both ear-<br>loop and tie-on types:<br>17.5cm×9.0cm &<br>18.0cm×9.0cm | Different | | OTC Use | Yes | Yes | Same | | Sterility | Sterile | Non-sterile | Different | | Packaging<br>material | Paper plastic bag | Not publicly available | Different | | Sterilization<br>method and<br>S.A.L. | Sterilized by ethylene<br>oxide gas, SAL= $10-6$ | Not applied | Different | | Shelf life | 2 years | No shelf life claim | Different | | Use | Single-use, disposable | Single-use, disposable | Same | | Performance | Level 3 | Level 3 | Same | | | | | | | level | | | | | Fluid<br>Resistance<br>Performance | 32 Out of 32 pass at<br>160mmHg<br>(ASTM F1862) | 32 Out of 32 pass at<br>160mmHg<br>(ASTM F1862) | Same | | Particulate<br>Filtration<br>Efficiency | Pass at ≥ 98%<br>(ASTM F2299) | Pass at ≥ 98%<br>(ASTM F2299) | Same | | Bacterial<br>Filtration<br>Efficiency | Pass at ≥ 98%<br>(ASTM F2101) | Pass at ≥ 98%<br>(ASTM F2101) | Same | | Differential<br>Pressure<br>(Delta-P) | Pass at <6mm H2O/cm²<br>(EN 14683:2019) | Pass at <5mm H2O/cm²<br>(MIL-M36945C) | Different | | Flammability | Pass at Class I<br>(16 CFR 1610) | Pass at Class I<br>(16 CFR 1610) | Same | | Cytotoxicity<br>ISO 10993-5 | Under the conditions of the<br>study, the subject device<br>was non-cytotoxic | Under the conditions of the<br>study, the subject device<br>was non-cytotoxic | Same | | Sensitization<br>ISO 10993-10 | Under the conditions of the<br>study, the subject device<br>was non-sensitizing | Under the conditions of the<br>study, the subject device<br>was non-sensitizing | Same | | Irritation<br>ISO 10993-10 | Under the conditions of the<br>study, the subject device<br>was non-irritating | Under the conditions of the<br>study, the subject device<br>was non-irritating | Same | {5}------------------------------------------------ {6}------------------------------------------------ Both of the proposed device and predicate device conform to ASTM F2100, the difference is the versions of the standard, the proposed device was tested by the latest version, and this difference will not raise any new safe and effective issue. From the comparison table and the gaps analysis above, the differences in the materials, layers, sizes, sterility status and packaging material will not raise any new issue for safety and effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices; EO sterilization validation has also been provided to prove the product sterility and performance; Accelerated aging test validates the shelf life of the proposed device. In summary, the performance and biocompatibility testing of the subject device meet all the requirements of standards of ASTM F2100 and ISO 10993-5 &-10. So, the differences between the predicate device and subject device will not raise any new issue of safety and effectiveness of the subject device. #### 7. Summary of Non-clinical Testing The following performance data of proposed device was provided in support of the substantial equivalence determination: {7}------------------------------------------------ # Biocompatibility testing The biocompatibility evaluation for the proposed device was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops or tie-on are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests: - · Cytotoxicity - · Skin Sensitization - Skin Irritation # Physical performance testing Physical performance was conducted, and the results show that the proposed device complies with the following standards: - ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks # Ethylene oxide Sterilization Validation The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards: - · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)] - · ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product - · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals - ASTM F88-2015 Standard Test Method for Seal Strength of Flexible Barrier Materials - · ASTM F1929-2015 Standard test method for detecting seal leaks in porous medical packaging by dye penetration # Summary Based on the non-clinical performance data as documented above in the device development, the proposed device has a safety and effectiveness profile that is similar to the predicate device, the testing results are summarized in the following table: | Name of Test<br>Methodology<br>(standard) | Purpose | Acceptance<br>Criteria | Results | |-------------------------------------------|------------------|------------------------|-------------------------| | ASTM F | Fluid Resistance | 29 out of 32 | Lot 1# pass at 160mmHg; | {8}------------------------------------------------ | 1862-17 | Performance | pass at<br>160 mmHg | Lot 2# pass at 160mmHg;<br>Lot 3# pass at 160mmHg | |---------------------|-----------------------------------------------------|---------------------|---------------------------------------------------------------------------------| | ASTM<br>F2101-19 | Bacterial Filtration<br>Efficiency<br>Performance | ≥ 98% | Lot 1# 99.7%-99.9%;<br>Lot 2# 99.7%-99.9%;<br>Lot 3# 99.7%-99.9% | | EN 14683:<br>2019 | Differential<br>Pressure (Delta-P) | < 6.0mm<br>H2O/cm² | Lot 1# 2.3-4.6;<br>Lot 2# 2.3-4.5;<br>Lot 3# 2.0-3.9 | | ASTM<br>F2299-2007 | Particulate<br>Filtration Efficiency<br>Performance | ≥ 98% | Lot 1# 99.2%-99.8%;<br>Lot 2# 99.0%-99.7%;<br>Lot 3# 99.3%-99.7% | | 16 CFR Part<br>1610 | Flammability | Class I | Lot 1# Class I;<br>Lot 2# Class I;<br>Lot 3# Class I | | ISO 10993-5 | Cytotoxicity | Non-cytotoxic | Under the conditions of the<br>study, the subject device was<br>non-cytotoxic | | ISO 10993-<br>10 | Sensitization | Non-<br>sensitizing | Under the conditions of the<br>study, the subject device was<br>non-sensitizing | | ISO 10993-<br>10 | Irritation | Non-irritating | Under the conditions of the<br>study, the subject device was<br>non-irritating | # 8. Brief discussion of clinical tests No clinical tests were performed. # 9. Conclusions The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission, the surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K160269.