Surgical Face 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. June 11, 2021 Zhuhai Gaoge Medical Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China Re: K203732 Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: April 25, 2021 Received: April 30, 2021 ## 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); 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, Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K203732 Device Name Surgical Face Mask ### Indications for Use (Describe) The Surgical 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. 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}------------------------------------------------ Image /page/3/Picture/0 description: The image contains the logo for "Gaoge". The logo consists of a blue hexagon-like shape with a white "G" inside, followed by the word "Gaoge" in a bold, sans-serif font. The color of the text is black. The logo appears to be for a company or organization named "Gaoge". # 510(k) Summary K203732 In accordance with 21 CFR 807.92 the following summary of information is provided: ## 1. SUBMITTER Zhuhai Gaoge Medical Technology Co., Ltd. 3rd floor, flat 5, No. 6 JinYuan one street, TangliaWan town, Zhuahai National Hi-tech industrial development zone, Zhuhai city, Guangdong province, China Phone: +86-0756-8803221 Fax: +86-0756-8307281 | Primary Contact<br>Person: | Olivia Meng<br>Regulatory Affairs Manager<br>Guangzhou Osmunda Medical Device Technical Service<br>Co., Ltd.<br>Tel: (+86)-20-6231 6262<br>Fax: (+86)-20-8633 0253 | |------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Secondary Contact<br>Person: | Xiangliang Cheng<br>Quality Manager<br>Zhuhai Gaoge Medical Technology Co., Ltd.<br>Phone: +86-0756-8803221<br>Fax: +86-0756-8307281 | | Date prepared | Apr 25th , 2021 | | 2. | DEVICE | | Device Name: | Surgical Face Mask | | Common name: | Mask, Surgical | | Model: | GK103 | | Regulation number | 21 CFR 878.4040 | | Regulation Class: | II | | Product Code: | FXX | #### PREDICATE DEVICE ന് K153496, Disposable Surgical Face Mask This predicate has not been subject to a design-related recall. {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Gaoge. The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black font. The logo is simple and modern, and the colors are eye-catching. #### 4. DEVICE DESCRIPTION The Surgical Face Mask is designed and manufactured by Zhuhai Gaoge Medical Technology Co., Ltd. It is non-sterile and for single use. The Surgical Face Mask has one model, GK103, that is the ear-loop style. It is made of three-layer nonwovens, ear loops and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The ear loops are made of polyester. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of iron wire wrapped with plastic. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed: - . Bacterial filtration efficiency (BFE) ≥ 98% - . Sub-micron particle filtration efficiency ≥ 98% - . Different pressure: < 6.0 mm H2O/cm2 - " Flammability: class 1 - . Resistance to penetration by synthetic blood: 120 mmHg #### 5. INDICATIONS FOR USE The Surgical 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. This is a single use, disposable device(s), provided non-sterile. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image contains a logo with the word "Gaoge" in a bold, sans-serif font. To the left of the word is a blue, geometric shape that resembles a cube with a "G" cut out of it. The cube is made up of several smaller, triangular shapes that give it a three-dimensional appearance. The overall design is modern and professional. # 6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE | Item | Proposed device | Predicate device | Comparison<br>result | |-------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Manufacturer | Zhuhai Gaoge Medical Technology<br>Co., Ltd. | Xiantao Rayxin Medical Products<br>Co., Ltd. | NA | | 510K Number | K203732 | K153496 | NA | | Product Common<br>Name | Surgical Face Mask | Disposable Surgical Face Mask | NA | | Intended Use | The Surgical Face Masks are<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. These face<br>masks are 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(s),<br>provided non-sterile. | The Disposable Surgical Face<br>Masks are intended to be worn to<br>protect both the patient and<br>healthcare personnel from<br>transfer of microorganisms, body<br>fluids and particulate material.<br>These face masks are intended for<br>use in infection control practices<br>to reduce the potential exposure<br>to blood and body fluids. This is a<br>single use, disposable device(s),<br>provided non-sterile. | Same | | Mask style | Flat pleated | Flat pleated | Same | | Design feature | Ear loop, 3 layers | Ear Loops, Tie-On, 3 layers | Similar | | Material of outer<br>facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | | Material of middle<br>layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | | Material of inner<br>facing layer | Spun-bond Polypropylene | Spun-bond Polypropylene | Same | | Nose piece | Galvanized iron wire wrapped<br>with polyethylene(PE) | Malleable aluminum wire | Similar | | Attachment | Ear loops: Polyester | Ear loops: Polyester<br>Tieon: Spun-bond Polypropylene | Similar | | Color | Blue | Blue | Same | | Dimension (Length<br>× Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.5 cm | Same | | OTC use | Yes | Yes | Same | | Sterility | Non-sterile | Non-sterile | Same | | Single use | Yes | Yes | Same | | ASTM F 2100 level | Level 2 | Level 2 | Same | | Fluid Resistance | For 3 non-consecutive lots. | 32 out of 32 pass | Same | | Performance | 32 out of 32 pass | at 120 mmHg | | | ASTM F1862 | at 120 mmHg | | | | Particulate<br>Filtration<br>Efficiency ASTM<br>F2299 | For 3 non-consecutive lots,<br>32 out of 32 pass,<br>average at 98.76% | 98.46% | Similar | | Bacterial<br>Filtration<br>Efficiency ASTM<br>F2101 | For 3 non-consecutive lots,<br>32 out of 32 pass,<br>average at 99.9% | 98.7% | Similar | | Differential<br>Pressure (Delta<br>P) ASTM<br>F2100 | For 3 non-consecutive lots,<br>32 out of 32 pass,<br>average at 3.7 $mmH_2O/cm^2$ | 4.2 $mmH_2O/cm^2$ | Similar | | Flammability 16<br>CFR 1610 | For 3 non-consecutive lots,<br>32 out of 32 pass,<br>Class 1<br>Non-Flammable | Class 1<br>Non-Flammable | Same | | Biocompatibility | | | | | Cytotoxicity | Under the conditions of the<br>study, not cytotoxicity effect | Under the conditions of the<br>study, not cytotoxicity effect | Same | | Irritation | Under the conditions of the<br>study, not an irritant | Under the conditions of the<br>study, not an irritant | Same | | Sensitization | Under conditions of the study,<br>not a sensitizer | Under conditions of the study,<br>not a sensitizer | Same | {6}------------------------------------------------ Image /page/6/Picture/0 description: The image contains the logo for Gaoge. The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black font. The hexagon is a gradient of blue, with the top being a lighter blue and the bottom being a darker blue. The proposed Surgical Face Mask and the predicate device is identical in the intended use, mask style, design feature, color, ASTM F2100 level and biocompatibility, and similar only in ear loops' material. So the proposed device is identical to the predicate device. #### 7. PERFORMANCE DATA The following performance data were provided to demonstrate that the subject device met the acceptance criteria of the test method or standard. ## Biocompatibility testing The biocompatibility evaluation for the Surgical Face Mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical {7}------------------------------------------------ Image /page/7/Picture/0 description: The image contains the logo for "Gaoge". The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black, sans-serif font. The logo is simple and modern, and the colors are eye-catching. devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: - Cytotoxicity (ISO 10993-5: 2009) ● - Sensitization - (ISO 10993-10:2010) - Skin Irritation - (ISO 10993-10:2010) ## Performance testing Performance testing was conducted on the Surgical Face Mask. All of the tested parameters met the predefined acceptance criteria. | Test item & Test Methods | Test purpose | Acceptance<br>criteria | Results | |-------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|---------| | Flammability<br>ASTM F2100-19<br>16 CFR Part 1610-2008 | Testing the characteristics of<br>a material that pertain to its<br>relative ease of ignition and<br>relative ability to sustain co<br>mbustion. | Class 1<br>ASTM F2100 | Pass | | Bacterial Filtration Efficiency<br>ASTM F2100-2019 9.1<br>ASTM F2101-2019 | Testing the effectiveness of<br>medical face mask material<br>in preventing the passage of<br>aerosolized bacteria. | Level 2: ≥ 98%<br>ASTM F2100 | Pass | | Different Pressure, mm H2O/cm²<br>ASTM F2100-19 9.2 | Measuring the pressure of<br>dropping across a medical<br>face mask material. | Level 2: < 6.0<br>ASTM F2100 | Pass | | Sub-Micron Particle Filtration<br>Efficiency<br>ASTM F2100-2019 9.3<br>ASTM F2299/F2299M-2017 | Testing the efficiency of the<br>filter material in capturing<br>aerosolized particles smaller<br>than one micron. | Level 2: ≥ 98%<br>ASTM F2100 | Pass | | Resistance to Penetration by<br>synthetic blood<br>ASTM F2100-2019 9.4<br>ASTM F1862/F1862-2017 | Testing the efficiency of<br>resistance to penetration by<br>synthetic blood. | Level 2: pass at<br>120 mmHg<br>ASTM F2100 | Pass | #### 8. CONCLUSION The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device.