Disposable Medical Face 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. The logo is simple and professional, and it is easily recognizable. July 12, 2021 Suzhou Bolisi Medical Technology Co., Ltd % Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China Re: K210244 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: June 7, 2021 Received: June 10, 2021 Dear Ryan 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, Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K210244 Device Name Disposable Medical Face Mask(145mm*95mm). Blue. Ear Loop type Disposable Medical Face Mask(175mm*95mm), Blue, Ear Loop type #### Indications for Use (Describe) The Disposable Medical Face 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. The Disposable Medical Face Masks are single use, disposable 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." PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(K) Summary-K210244 #### I. SUBMITTER: Suzhou Bolisi Medical Technology Co.,Ltd Baijiaqiao industrial community, Yangshe Town, Zhangjiagang City, Jiangsu Province, China Contact Person: Hong Xu Title: General Manager Tel: +86 13776246881 Email: zjgbolisi@163.com Submission Correspondent: Ryan Li Email: ryan.li@mind-link.net Tel:+86 13701581791 Summary prepared: June 28, 2021 #### II. DEVICE Name of Device: Disposable Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX ## III. PREDICATE DEVICE Predicate: K210007 Trade/Device Name: Face Mask Manufacturer: Jinhua Jingdi Medical Supplies Co.,Ltd Product Code: FXX {4}------------------------------------------------ Classification Name: Mask, surgical Regulation Number: 21 CFR 878.4040 # IV. DEVICE DESCRIPTION Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose. ## V. AVAILABLE MODELS The Disposable Medical Face Masks are available in two models including different sizes. For the 145mm*95mm model is in blue, barrier level 2 and size 145mm*95mm, ear loop type. For the 175mm*95mm model is in blue, barrier level 2 and size 175mm*95mm, ear loop type. ## VI. INDICATIONS FOR USE The Disposable Medical Face 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE The Disposable Surgical Masks are compared with the predicate device (Face Mask (K210007)). The results are shown below in the Technological Characteristics Comparison Table: {5}------------------------------------------------ | DEVICE | Subject Device | Primary Predicate Device | Comparison | |---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------| | | Disposable Medical Face Mask | Face Mask (K210007 ) | | | Intended Use | The Disposable Medical Face 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile. | The face mask 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. The face mask is a single-use, disposable device, provided non-sterile. | Same | | Classification | FXX | FXX | Same | | Product Code | | | | | Ear Loop Model | Ear Loops | Ear Loops | Same | | Materials | | | | | Outer Layer | Facing Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene non-woven fabric | Similar Note 1 | | Middle Layer | Melt-blown polypropylene | Melt-blown polypropylene | Similar Note 1 | | Inner Layer | Facing Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene non-woven fabric | Similar Note 1 | | Nose Piece | Galvanized iron wire | Iron wire covered polypropylene | Different Note 1 | | Ear Loops | 82% Spandex<br>18% Polyester | 75% Polyester<br>25% Spandex | Similar Note 1 | | Design Features | | | | | Color | Blue | Blue | Same | | Style | Flat - Pleated | Flat - Pleated | Same | | Multiple Layers | 3 Layers | 3 Layers | Same | | Single Use | Single use | Single use | Same | | | Sterility | | | | Sterile | Non-sterile | Non-sterile | Same | | Dimensions | | | | | Length × Width | $145\times95$ mm (±5mm)<br>$175\times95$ mm (±5mm) | $145\times95$ mm (±5mm)<br>$175\times95$ mm (±5mm) | Same | | Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2 | | | | | Fluid Resistance<br>ASTM F1862 | 32 out of 32 Pass at 120mmHg | 32 out of 32 pass at 120mmHg | Same | | Particulate<br>Filtration<br>Efficiency (PFE)<br>ASTM F2299 | Pass at ≥98% | Pass at 99.70% | Similar<br>Note 2 | | Bacterial<br>Filtration<br>Efficiency (BFE)<br>ASTM F2101 | Pass at ≥98% | Pass at 99.95% | Similar<br>Note 2 | | Differential<br>Pressure (Delta<br>P)MIL-M-36954C | Pass at $<6.0$ mmH2O/cm² | Pass at 3.0 mmH2O/cm² | Similar<br>Note 2 | | Flammability<br>16 CFR PART<br>1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Same | | Biocompatibility | | | | | Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | | Same | | Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | | Same | | Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | | Same | {6}------------------------------------------------ # Comparison in Detail(s): Note 1: Although the material including outer layer, middle layer, inner layer, nose piece and ear loops is a little different from the predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. {7}------------------------------------------------ # Note 2: Although the Particulate Filtration Efficiency, Bacterial Filtration Efficiency and Differential Pressure of the subject device is a little different from the predicate device. However, they all meet the requirements of essential performance standard ASTM F 2100. Therefore, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. # VIII. PERFORMANCE DATA | Performance<br>Characteristics | Test Method | Pass Criteria<br>For Level 2 | Test Results | |---------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------|--------------| | Bacterial<br>Filtration<br>Efficiency | ASTM F2101 Standard Method<br>for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of<br>Medical Face Mask Materials,<br>Using a Biological Aerosol of<br>Staphylococcus aureus | ≥98% | Pass | | Differential<br>Pressure<br>(Delta-P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test methods<br>according to ASTM F2100:2019 | <6.0 mm<br>H2O/cm² | Pass | | Sub-Micron<br>Particulate<br>Filtration<br>Efficiency<br>(PFE) at 0.1<br>micron | ASTM F2299 Standard Test<br>Method for Determining the<br>Initial Efficiency of Materials<br>Used in Medical Face Masks to<br>Penetration by Particulates<br>Using Latex Spheres | ≥98% | Pass | | Resistance to<br>Penetration by<br>Synthetic<br>Blood | ASTM F1862 Standard Test<br>Method for Resistance of<br>Medical Face Masks to<br>Penetration by Synthetic Blood<br>(Horizontal Projection of Fixed<br>Volume at a Known Velocity) | Fluid resistant at<br>120 mm Hg | Pass | | Flammability | 16 CFR Part 1610 Standard for<br>the Flammability of Clothing | Class 1 | Pass | ### Summary of Non-Clinical Performance Test {8}------------------------------------------------ ## Biocompatibility Testing Based on ISO 10993-1:2018, the subject device contacts intact skin and its contact duration is less than or equal to 24h. Therefore, the following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intend use: - In vitro Cytotoxicity Test per ISO 10993-5: 2009 Biological evaluation of ● medical devices- Part 5: Tests for in vitro cytotoxicity - Skin Sensitization Tests per ISO 10993-10: 2010 Biological evaluation of ● medical devices- Part 10: Tests for irritation and skin sensitization - Skin Irritation Tests per ISO 10993-10: 2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization ## Clinical Test No clinical study is included in this submission. # IX. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the subject device, the Disposable Medical Face Mask is as safe, as effective, and performs as well as the legally marketed predicate device Face Mask (K210007).