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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text. April 22, 2021 Guangzhou Mei Yi Kang Medical Technology CO., LTD. % Cassie Lee Official Correspondent Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, China, zip code 510000 Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com Re: K203646 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: March 31, 2021 Received: April 5, 2021 Dear Cassie Lee: 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. For Ryan Ortega, Ph.D. 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) K203646 Device Name Disposable Medical Face Mask Indications for Use (Describe) 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile. Models: MK-34, DY 95, DY 96, DY 97 Type of Use (Select one or both, as applicable) | | Tenant-occupied property | |--|--------------------------| | | Owner-occupied property | | | 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 for K203646 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. # 1. Submitter's Information Sponsor Name: GUANGZHOU MEI YI KANG MEDICAL TECHNOLOGY CO., LTD. Address: No.43-31 Baofeng East Road,JinShi North Avenue, Shiling Town, Huadu District, Guangzhou City, Guangdong Province, China. Post Code: 510800 Contact name: Luo Yonghui Tel: 020-22682888 E-mail: deyce988@deyce.cn # Application Correspondent: Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8200 6973 Email: regulatory@glomed-info.com # 2. Date of the summary prepared: April 21, 2021 # 3. Subject Device Information Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Medical Face Mask Model Name: MK-34, DY 95, DY 96, DY 97 Review Panel: Surgical Apparel Product Code: FXX Requlation Number: 878.4040 Regulatory Class: II # 4. Predicate Device Information # Predicate Device: Sponsor: Skypro Medical Supplies Company {4}------------------------------------------------ Trade Name: Skypro, SP01 Mask Classification Name: Mask, Surgical Common name: Surgical Mask 510(K) Number: K152197 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II ### 5. Device Description The Disposable Medical Face Mark is blue color, and flat pleated type mask, utilizing ear loops or tie-on way for wearing, and has nose strip design for fitting the facemask around the nose. The colorant used in the mask outer layer is blue: Copper phthalocyanine/ CAS number: 147-14-8). The proposed device is manufactured with three layers, the inner and outer layers made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model DY 96, tie-on, is held in place over the user's mouth and nose by four straps welded to the facemask. The straps are made of Spun-bond polypropylene. Its dimension is 17.5x9.5cm, strap is 38 cm, nose strip is 9.5±0.5 cm. The models MK-34, DY 95 and DY 97, ear loops, are held in place over the user's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are made of Nylon and Spandex, not made with natural rubber latex. The dimension of MK-34 is 14.5x9.5cm, ear loop is 13cm, nose strip is 9.5±0.5 cm. The dimension of DY 95 and DY 97 is 17.5x9.5cm, ear loop is 13 cm, nose strip is 9.5±0.5 cm. The nose strip contained in the proposed device is in the layers of facemask to allow the user to fit the facemask around their nose, which is made of PE and galvanized iron wire. The device is sold non-sterile and are intended to be single use, disposable device. | Model | Materials | Contact<br>classification | colorants | Size | Style<br>differences | |-------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--------------------------------------------------------|----------|---------------------------------------------------------------------| | MK-34 | Outer layer:<br>spunbond<br>polypropylene,<br>Inner layer: melt<br>blown polypropylene,<br>Nose strip: PE and<br>galvanized iron wire,<br>Ear loops: Nylon and<br>Spandex | Less than<br>24 hours | Copper<br>phthalocyanine/<br>CAS number:<br>147-14-8). | 145x95mm | Ear loop style,<br>the ear loop is<br>welded on the<br>outer layer. | The difference between the 4 models as below: {5}------------------------------------------------ | DY 95 | Outer layer:<br>spunbond<br>polypropylene,<br>Inner layer: melt<br>blown polypropylene,<br>Nose strip: PE and<br>galvanized iron wire,<br>Ear loops: Nylon and<br>Spandex | Less than<br>24 hours | Copper<br>phthalocyanine/<br>CAS number:<br>147-14-8). | 175x95mm | Ear loop style,<br>the ear loop is<br>welded on the<br>outer layer. | |-------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|--------------------------------------------------------|----------|---------------------------------------------------------------------| | DY 96 | Outer layer:<br>spunbond<br>polypropylene,<br>Inner layer: melt<br>blown polypropylene,<br>Nose strip: PE and<br>galvanized iron wire,<br>Ties: Spun-bond<br>polypropylene | Less than<br>24 hours | Copper<br>phthalocyanine/<br>CAS number:<br>147-14-8). | 175x95mm | Tie-on style | | DY 97 | Outer layer:<br>spunbond<br>polypropylene,<br>Inner layer: melt<br>blown polypropylene,<br>Nose strip: PE and<br>galvanized iron wire,<br>Ear loops: Nylon and<br>Spandex | Less than<br>24 hours | Copper<br>phthalocyanine/<br>CAS number:<br>147-14-8). | 175x95mm | Ear loop style,<br>the ear loop is<br>welded on the<br>inner layer. | # 6. Intended Use / Indications for Use 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. This face mask is intended for use in infection control practices to reduce the potential exposure of the wearer to blood and body fluids. The mask is a single use, disposable device, provided non-sterile. # 7. Comparison of Technological Characteristics The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. {6}------------------------------------------------ | Elements of<br>Comparison | Subject Device | Predicate Device | Results | |-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Company | GUANGZHOU MEI YI<br>KANG MEDICAL<br>TECHNOLOGY Co., Ltd. | Skypro Medical Supplies<br>Company | -- | | 510 (k) | K203646 | K152197 | -- | | Trade Name | Disposable Medical Face Mask | Skypro, SP01 Mask | -- | | Classification<br>Name | Mask, Surgical | Mask, Surgical | Same | | Classification | Class II | Class II | Same | | Product Code | FXX | FXX | Same | | Intended use | Disposable Medical Face Mask<br>is 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 of<br>the wearer to blood and body<br>fluids. The mask is a single use,<br>disposable device, provided<br>non-sterile. | The Skypro, SP01 Mask is<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 of the wearer to<br>blood and body fluids. The<br>mask is a single use,<br>disposable device, provided<br>non-sterile. | Same | | Materials | | | | | Outer layer | Spunbond Polypropylene | Polypropylene | Same | | Middle filter layer | Melt blown Polypropylene | Meltblown | Same | | Inner layer | Spunbond Polypropylene | Polypropylene | Same | | Nose strip | PE and galvanized iron wire | Metal wires embedded in<br>polyester or non-woven<br>ties | Similar<br>Note 1 | | Ear loops for MK-<br>34, DY 95, DY 97 | Nylon and Spandex | -- | Note 1 | | Straps for DY 96 | Spun-bond polypropylene | -- | Note 1 | | Ear attachment | Eastic earloop (for models MK-<br>34, DY 95, DY 97) | Eastic earloop or Ties | Same | | Color | Blue | White | Different<br>Note 1 | | Dimensions | MK-34: 145x95mm<br>DY 95, DY96, DY 97:<br>175x95mm | Gent loop mask size:<br>175x95mm<br>Lady loop mask size:<br>145x95mm<br>Tie on mask size:<br>175x95mm | Similar | | Mask style | Flat pleated | Flat pleated | Same | | Design features | 3 layers of non---woven fiber<br>with fiber web in the middle | 3 layers of non-woven fiber<br>with fiber web in the middle | Same | | Sterile | Non-Sterile<br>Single use | Non-Sterile<br>Single use | Same | | Shelf Life | 2 years | Not publicly available | Note 2 | | Fluid Resistance<br>Performance | Pass at 120 mm Hg | Pass at 120 mm Hg | Same | | Particulate<br>Filtration<br>Efficiency | Model MK-34, DY 95 and DY<br>97: 98.9%<br>Model DY 96: 99.3% | 99.28% | Similar<br>Note 3 | | Bacterial<br>Filtration<br>Efficiency | Model MK-34, DY 95 and DY<br>97: 99.8%<br>Model DY 96: 99.9% | 99.66% | Similar<br>Note 3 | | Differential<br>Pressure | Model MK-34, DY 95 and DY<br>97: 4.2 mm H2O/cm²<br>Model DY 96: 4.0mm H2O/cm² | 3.72 mm H2O/cm² | Similar<br>Note 3 | | Flammability | Class 1 | Class 1 | Same | | Latex | Not made with natural latex | Not made with natural latex | Same | | Biocompatibility | | | | | Cytotoxicity | Under the conditions of the<br>study, Non-cytotoxic | Non-cytotoxic | Same | | Irritation | Under the conditions of the<br>study, Non-irritating | Non-irritating | Same | | Sensitization | Under the conditions of the<br>study. Non- sensitization | Non- sensitization | Same | # Comparison in Detail(s): {7}------------------------------------------------ # Note 1: Although the "Nose strip", "Ear loop", "Straps" and "Color" is a little different from the predicate devices, but it met the ISO 10993 standards and ASTM F2100 level II required. So, the differences between the subject device and the predicate device will not affect the safety and effectiveness. {8}------------------------------------------------ # Note 2: Although the "Shelf life" of subject device is different from predicate device, but they all met the ASTM F2100 standard level II required after 81 days accelerated aging under 60°℃, so the difference between subject device and predicate device will not affect the safety and effectiveness. Note 3: Although the "Particulate Filtration Efficiency ", "Bacterial Filtration Efficiency ", and "Differential Pressure" of subject device is a little different from predicate device, but they all met the ASTM F2100 standard level II required. So, the differences between the subject device and predicate device will not affect the safety and effectiveness. # 8. Summary of Non-Clinical Performance Testing | Test item<br>(Performance<br>Level 2 according<br>to ASTM F2100) | Test method | Pass<br>criteria | Test results | |----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------|---------------------------------------------------------------------------------------------------| | Bacterial filtration<br>efficiency | ASTM F2101-14 Standard Test<br>Method for Evaluating the Bacterial<br>Filtration Efficiency (BFE) of<br>Medical Face Mask Materials,<br>Using a Biological Aerosol of<br>Staphylococcus aureus according<br>to ASTM F2100:2019 | ≥ 98% | Model MK-34,<br>DY 95 and DY<br>97: 99.8%<br>Model DY<br>96: 99.9%<br>Pass | | Differential<br>pressure (Delta-P) | EN 14683: 2019, Annex C Medical<br>face masks - Requirements and<br>test methods according to ASTM<br>F2100:2019 | <6.0<br>mm<br>H2O/cm² | Model MK-34,<br>DY 95 and DY<br>97: 4.2 mm<br>H2O/cm²<br>Model DY<br>96: 4.0mm<br>H2O/cm²<br>Pass | | Sub-micron<br>particulate filtration<br>efficiency<br>at 0.1 µm of<br>Polystyrene Latex<br>Spheres | ASTM F2299-03 Standard Test<br>Method for Determining the Initial<br>Efficiency of Materials Used in<br>Medical Face Masks to Penetration<br>by Particulates Using Latex<br>Spheres according to ASTM<br>F2100:2019 | ≥ 98% | Model MK-34,<br>DY 95 and DY<br>97: 98.9%<br>Model DY<br>96: 99.3%<br>Pass | - . Performance Testing summary {9}------------------------------------------------ | penetration by<br>synthetic<br>blood, minimum<br>pressure in mm Hg<br>for pass result | Standard Test Method for Resistance<br>of Medical Face Masks to Penetration<br>by Synthetic Blood (Horizontal<br>Projection of Fixed Volume at a<br>Known Velocity) according to ASTM<br>F2100:2019 | resistant<br>claimed<br>at 120<br>mm Hg | Pass at 120<br>mm Hg<br>Pass | |---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------|------------------------------| | Flame spread | 16 CFR Part 1610 Standard for the<br>Flammability of Clothing according<br>to ASTM F2100:2019 | Class 1 | Class 1<br>Pass | #### ● Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: | Test Item | Test Method | Proposed device | Result | |---------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------|--------| | Cytotoxicity | ISO 10993-5: 2009 Biological<br>evaluation of medical devices-<br>Part 5: Tests for in vitro<br>cytotoxicity | Under the conditions of the study,<br>the subject device extract<br>was determined to be non-<br>cytotoxic. | PASS | | Irritation | ISO 10993-10: 2010 Biological<br>evaluation of medical devices-<br>Part 10: Tests for irritation and<br>skin sensitization | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined<br>to be non-irritating. | PASS | | Sensitization | ISO 10993-10: 2010 Biological<br>evaluation of medical devices-<br>Part 10: Tests for irritation and<br>skin sensitization | Under the conditions of the study,<br>the subject device non-polar and<br>polar extracts were determined<br>to be non-sensitizing. | PASS | # 9. Summary of Clinical Performance Test No clinical study is included in this submission. # 10. Final Conclusion: The conclusion drawn from the nonclinical test demonstrates that the subject device in 510(K) submission K203646, the Disposable medial face mask is as effective, and performs as well as or better than the legally marketed predicated device cleared under K152197.