Medical surgical mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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. November 23, 2020 Shenzhen Everwin Precision Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Services Co. Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China Re: K201991 Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 10, 2020 Received: July 17, 2020 ### Dear Olivia Meng: 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 and 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-reporting- combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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. 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) K201991 Device Name Medical surgical mask Indications for Use (Describe) The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is intended for use in infection control practices to reduce the potential exposure to blood fluids. This is a 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." {3}------------------------------------------------ ### 510(k) Summary K201991 ### 1. SUBMITTER Shenzhen Everwin Precision Technology Co., Ltd. Building 3, Third Industrial Zone, FuqiaoQiaotou, Fuyong town, Bao'an district, Shenzhen, China Phone: +86-13925511162 Fax: +86-755-27343466 | Primary Contact | Olivia Meng | |-------------------|----------------------------------------------------| | Person: | Regulatory Affairs Manager | | | Guangzhou Osmunda Medical Device Technical Service | | | Co., Ltd. | | | Tel: (+86)-20-6231 6262 | | | Fax: (+86) -20-8633 0253 | | Secondary Contact | Guoshun Shi | | Person: | Quality System Senior Manager | Shenzhen Everwin Precision Technology Co., Ltd. Phone: +86-13925511162 Fax: +86-755-27343466 November 23, 2020 Date prepared - 2. DEVICE | Trade Name: | Medical Surgical Mask | |---------------------|-----------------------| | Common name: | Surgical Mask | | Model: | EWPT0005 | | Classification name | Mask, Surgical | | Regulation number | 21 CFR 878.4040 | | Regulation Class: | Class II | | Product Code: | FXX | 3. PREDICATEDEVICE K160269, Surgical Face Masks (Ear loops and Tie-on) #### 4. DEVICE DESCRIPTION The medical surgical mask is designed and manufactured by Shenzhen Everwin {4}------------------------------------------------ Precision Technology Co, Ltd. It is non-sterile and for single use. It's a disposable device. The medical surgical mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elasticear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from steel wire. #### 5. INDICATIONS FOR USE The medical surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. This face mask is 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 non-sterile. | Comparison Item | Proposed device | Predicate device | Comparison<br>result | |-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | 510k number | K201991 | K160269 | - | | Intended Use | The medical surgical mask is<br>intended to be worn to protect<br>both the patient and healthcare<br>personnel from transfer of<br>microorganisms, body fluids, and<br>particulate material. This face<br>mask is intended for use in<br>infection control practices to<br>reduce the potential exposure to<br>blood and body fluids. This is a<br>single-use, disposable device,<br>provided non-sterile. | The surgical face 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,<br>provided non-sterile. | Same | | Mask style | Flat pleated | Flat pleated | Same | | Design feature | Ear loop | Earloop or tie-on | Similar | | Material of outer<br>facing layer | Polypropylene | Polypropylene | Same | | Material of<br>middle layer | Melt blown polypropylene | Polypropylene meltblown<br>and<br>polypropylene | Similar | #### 6. Summary of Technological Characteristics {5}------------------------------------------------ K201991 | | | spunbond | | |-----------------------------------|------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------| | Material of inner<br>facing layer | Polypropylene | Polypropylene | Same | | Nosepiece | Polypropylene coated steel wire | Polypropylene coated<br>steel wire | Same | | Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester,<br>polyurethane Side tapes:<br>Polyester spunbond (ear<br>loops mask only) Tie tapes:<br>Polypropylene spunbondor<br>polyester spunbond | Similar | | Dimension<br>(Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm<br>18.0 cm × 9.0 cm | Similar | | OTC use | Yes | Yes | Same | | Sterility | Non-sterile | Non-sterile | Same | | Single use | Yes | Yes | Same | | ASTM F 2100<br>level | Level 3 | Level 1<br>Level 2<br>Level 3 | Similar | | Biocompatibility | Pass ISO 10993cytotoxicity, skin<br>irritation and skin sensitivity<br>tests | Pass ISO<br>10993cytotoxicity, skin<br>irritation and skin<br>sensitivity tests | Same | The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is identical to the predicate device. #### PERFORMANCE DATA 7. # 7.1. Non-clinical test performed on the proposed device The following performance data were provided in support of the substantial equivalence determination. # Biocompatibility testing The biocompatibility evaluation for the medical surgical mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of {6}------------------------------------------------ medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: | Item | Acceptance<br>Criteria | Proposed<br>device | Predicate<br>device | Result | |-----------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|--------| | Cytotoxicity | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>cytotoxic. | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>cytotoxic. | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>cytotoxic | Same | | Sensitization | Under the<br>conditions of the<br>study, the subject<br>device was<br>non-sensitizing | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>sensitizing. | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>sensitizing. | Same | | Skin Irritation | Under the<br>conditions of the<br>study, the subject<br>device was<br>non-irritating. | Under the<br>conditions of the<br>study, the<br>subject device was<br>non-irritating. | Under the<br>conditions of the<br>study, the subject<br>device was non-<br>irritating. | Same | # Performance testing Performance testing was conducted on the medical surgical mask. All of the tested parameters met the predefined acceptance criteria. | Item | Proposed<br>device | Predicate<br>device | Acceptance<br>Criteria | Result | |---------------------------------------|--------------------|---------------------|------------------------|--------| | Flammability | Class I | Class I | Class I | Same | | Bacterial<br>Filtration<br>Efficiency | >=98% | 98% | >=98% | Same | {7}------------------------------------------------ | | | | | K201991 | |-----------------------------------------------------------------|--------------------------------------|--------------------------------------|-----------------------------------|---------| | Item | Proposed device | Predicate device | Acceptance Criteria | Result | | Differential<br>Pressure, mm<br>H2O/cm2 | <6.0 H2O/cm2 mm | Pass at average<br>5.5 mm H2O/cm2 | <6.0 H2O/cm2 mm | Similar | | Sub-Micron<br>Particle<br>Filtration<br>Efficiency | >= 98% | Average 99.8% | >= 98% | Similar | | Resistance to<br>Penetration<br>by Synthetic<br>Blood<br>(mmHg) | 29 out of 32 at<br>passes<br>160mmHg | 29 out of 32 passes<br>at<br>160mmHg | 29 out of 32 passes<br>at 160mmHg | Same | # 7.2. Clinical test conclusion No clinical study is included in this submission. ## 8. CONCLUSION ### 8.1. Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Surgical Face Mask (K160269).