Medical Protective Mask (model: 8862, 8862A, 8862B, 8862C, 8862D, 8862E)

{0}------------------------------------------------ November 23, 2022 Image /page/0/Picture/1 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Guangdong Golden Leaves Technology Development Co., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 523000 China Re: K223068 Trade/Device Name: Medical Protective Mask (model: 8862, 8862B, 8862C, 8862D, 8862E) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 28, 2022 Received: September 30, 2022 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. 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 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, **Anne D. Talley** -S for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K223068 #### Device Name Medical Protective Mask (model: 8862, 8862A, 8862C, 8862C, 8862D, 8862E) Indications for Use (Describe) The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| For activities where HUD funding is NOT being directly obligated or expended For activities where HUD funding IS being directly obligated or expended | | 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 of K223068 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: Guangdong Golden Leaves Technology Development Co., Ltd. Address: 5F, BLDG 2, #8, Qiaolonghe East Rd, Tangxia Town, Dongguan, Guangdong, 523730, China Post Code: 523730 Contact name: Wenhong Zhou Tel: +86-13416994806 E-mail: info@gdgoldenleaves.com #### Application Correspondent: Contact Person: Ms. Cassie Lee Company: Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@share-info.com #### 2. Date of the summary prepared: Jun 26, 2022 #### 3. Subject Device Information Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: Medical Protective Mask Model Name: 8862, 8862A, 8862B, 8862C, 8862D, 8862E Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II ### 4. Predicate Device Information #### Predicate Device: Sponsor: Jiangxi Hongda Medical Equipment Group Co., Ltd. Trade Name: Single-Use Medical Face Mask Classification Name: Mask, Surgical {4}------------------------------------------------ 510(K) Number: K210622 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II #### 5. Device Description The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. | Type<br>Level | Ear Loop | Headband | |---------------|----------|----------| | Level 1 | 8862B | 8862E | | Level 2 | 8862A | 8862D | | Level 3 | 8862 | 8862C | Both the ear loop and headband masks are available in level 1, level 2 and level 3: All models are made of the same material and have identical performance, meeting the performance requirements of three levels at the same time. The device is provided non-sterile. #### 6. Intended Use / Indications for Use The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile. #### 7. Comparison to predicate device and conclusion The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness. | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Verdict | |-----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Company | Guangdong Golden Leaves<br>Technology Development Co., | Jiangxi Hongda Medical<br>Equipment Group Co., Ltd. | -- | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Verdict | | | Ltd. | | | | 510 (k) | K223068 | K210622 | -- | | Trade Name | Medical Protective Mask | Single-Use Medical Face Mask | -- | | Classification<br>Name | Mask, Surgical | Mask, Surgical | Same | | Classification | Class II | Class II | Same | | Product Code | FXX | FXX | Same | | Intended use | The Medical Protective Mask<br>is 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 masks are<br>intended for use in infection<br>control practices to reduce the<br>potential exposure to blood<br>and body fluids. This is a<br>single-use, disposable device,<br>provide non-sterile. | The single-use medical 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<br>for use in infection control<br>practices to reduce the potential<br>exposure to blood and body<br>fluids. This is a single-use,<br>disposable device,<br>provided sterile and non-sterile. | Same | | Mask style | Flat-folded | Flat-pleated | Same | | Design feature | Ear loop, headband | Ear loop or tie-on | Similar<br>Note 1 | | Color | Green | White | Different<br>Note 1 | | Dimension | Mask body: 205x80mm<br>Nose clip: 100mm<br>Ear loop: 150mm<br>Headband: 350mm | Mask body: 175x95mm<br>Nose Clip: 80~105mm<br>Ear loop: 140~150mm<br>Ties: 330~400mm | Similar<br>Note 1 | | Use | Single Use, Disposable | Single Use, Disposable | Same | | Materials | | | | | Outer facing layer | Polypropylene Spunbonded<br>Nonwoven | Polypropylene Spunbonded<br>Nonwoven | Same | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Verdict | | Filter layer | Polypropylene Melt-blown<br>Nonwoven | Polypropylene Melt-blown<br>Nonwoven | Same | | Inner facing layer | Polypropylene Spunbonded<br>Nonwoven | Polypropylene Spunbonded<br>Nonwoven | Same | | Nose Clip | Polypropylene and wire | Polypropylene and iron | Similar<br>Note 1 | | Ear<br>loops/headband | Polyester | Polyester and spandex | Similar<br>Note 1 | | Performance Characteristics | | | | | ASTM F2100<br>Level | Level 1, Level 2, Level 3 | Level 1, Level 2, Level 3 | Same | | Fluid resistance | Level 1: Pass at 80 mmHg<br>Level 2: Pass at 120 mmHg<br>Level 3: Pass at 160 mmHg | Level 1: Pass at 80 mmHg<br>Level 2: Pass at 120 mmHg<br>Level 3: Pass at 160 mmHg | Same | | Particulate<br>filtration<br>efficiency | Level 1: ≥95%<br>Level 2: ≥98%<br>Level 3: ≥98% | Level 1:<br>Ear loop (Non-sterile): ≥95%<br>Level 2:<br>Ear loop (Non-sterile): ≥98%<br>Level 3:<br>Ear loop (Non-sterile): ≥98% | Same | | Bacterial filtration<br>efficiency | Level 1: ≥95%<br>Level 2: ≥98%<br>Level 3: ≥98% | Level 1:<br>Ear loop (Non-sterile): ≥95%<br>Level 2:<br>Ear loop (Non-sterile): ≥98%<br>Level 3:<br>Ear loop (Non-sterile): ≥98% | Same | | Differential<br>pressure | Level 1: <5 mmH2O/cm²<br>Level 2: <6 mmH2O/cm²<br>Level 3: <6 mmH2O/cm² | Level 1:<br>Ear loop (Non-sterile): <5 mmH2O/cm²<br>Level 2:<br>Ear loop (Non-sterile): <6 mmH2O/cm²<br>Level 3: | Same | | Elements of<br>Comparison | Subject Device | Predicate Device 1 | Verdict | | Fluid resistance | Level 1: Pass at 80 mmHg<br>Level 2: Pass at 120 mmHg<br>Level 3: Pass at 160 mmHg | mmH2O/cm2<br>Level 1: Pass at 80 mmHg<br>Level 2: Pass at 120 mmHg<br>Level 3: Pass at 160 mmHg | Same | | Flammability | Class I | Class I | Same | | Sterility | Non-sterile | Non sterile/Sterile | Same | | Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | | Shelf Life | 2 years | 3 years | Different<br>Note 2 | | Biocompatibility | | | | | Cytotoxicity | Under the conditions of the<br>study, the proposed<br>device was non-cytotoxic. | Under the conditions of the study,<br>the proposed<br>device was non-cytotoxic. | Same | | Sensitization | Under the conditions of the<br>study, the proposed<br>device was non-sensitizing. | Under the conditions of the study,<br>the proposed<br>device was non-sensitizing. | Same | | Irritation | Under the conditions of the<br>study, the proposed<br>device was non-irritating. | Under the conditions of the study,<br>the proposed<br>device was non-irritating. | Same | {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ ## Comparison in Detail(s): #### Note 1: Although there are a few differences in "Design feature", "Dimension", materials of "Ear loops/headband" and "Nose Clip" of the subject device and predicate device, they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and the predicate devices will not affect the safety and effectiveness. ## Note 2: Although the "Shelf life" of the subject device is a little different from the predicate device, the performance testing of the subject device after accelerated aging has been conducted and the test results show that the subject device after the aging meets the all-performance requirements of ASTM F2100. So, the differences between the subject device and predicate device will not affect the safety and effectiveness. {8}------------------------------------------------ # 8. Summary of Non-Clinical Performance Testing ## Performance Testing summary | | | Pass criteria | | | Test | |--------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-------------------------|-------------------------|---------------------| | Test item | Test method | For<br>Level 1 | For Level<br>2 | For<br>Level 3 | results<br>/Verdict | | Bacterial<br>filtration<br>efficiency | ASTM F2101-19 Standard<br>Test Method for Evaluating<br>the Bacterial Filtration<br>Efficiency (BFE) of Medical<br>Face Mask Materials, Using<br>a Biological Aerosol of<br>Staphylococcus aureus<br>according to ASTM F2100:<br>2019 | ≥ 95% | ≥ 98% | ≥ 98% | Pass | | Differential<br>pressure<br>(Delta-P) | EN 14683: 2019, Annex C<br>Medical face masks -<br>Requirements and test<br>methods according to<br>ASTM F2100: 2019 | <5.0 mm<br>H2O/cm² | <6.0 mm<br>H2O/cm² | <6.0 mm<br>H2O/cm² | Pass | | Sub-micron<br>particulate<br>filtration<br>efficiency at<br>0.1 µm of<br>Polystyrene<br>Latex Spheres | ASTM F2299 Standard Test<br>Method for Determining the<br>Initial Efficiency of Materials<br>Used in Medical Face<br>Masks to Penetration by<br>Particulates Using Latex<br>Spheres according to ASTM<br>F2100: 2019 | ≥ 95% | ≥ 98% | ≥ 98% | Pass | | Resistance to<br>penetration by<br>synthetic<br>blood,<br>minimum<br>pressure in<br>mm Hg for<br>pass result | ASTM F1862/F1862M-17<br>Standard Test Method for<br>Resistance of Medical Face<br>Masks to Penetration by<br>Synthetic Blood (Horizontal<br>Projection of Fixed Volume at<br>a Known Velocity) according<br>to ASTM F2100:2019 | Pass at<br>80 mm<br>Hg | Pass at<br>120 mm<br>Hg | Pass at<br>160 mm<br>Hg | Pass | | | 16 CFR Part 1610 Standard<br>for the Flammability of<br>Clothing according to ASTM<br>F2100:2019 | | | | | | Flame<br>spread | | Class 1 | Class 1 | Class 1 | Pass | {9}------------------------------------------------ ## Biocompatibility Testing According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is B-prolonged (>24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: | Title of the test | Purpose of the<br>test | Reference<br>for<br>Test method | Acceptance<br>criteria | Test<br>results | |-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-----------------| | In vitro<br>Cytotoxicity Test | Under the research<br>conditions.<br>determine whether<br>the target device<br>extract is cytotoxic. | ISO 10993-5:2009<br>Biological evaluation<br>of medical devices-<br>Part 5: Tests for in<br>vitro cytotoxicity | Under the<br>conditions of the<br>study, the subject<br>device extract was<br>determined to be<br>non-cytotoxic. | Pass | | Skin<br>Sensitization<br>Test | Under the research<br>conditions,<br>determine whether<br>the non-polar and<br>polar extracts of<br>the target device<br>are sensitive. | ISO 10993-10:2010<br>Biological evaluation<br>of medical devices-<br>Part 10: Tests for<br>irritation and skin<br>sensitization | Under the<br>conditions of the<br>study, the subject<br>device non-polar<br>and polar extracts<br>were determined to<br>be non-sensitizing. | Pass | | Skin Irritation<br>Test | Under the research<br>conditions,<br>determine whether<br>the non-polar and<br>polar extracts of<br>the target device<br>are irritating. | ISO 10993-10:2010<br>Biological evaluation<br>of medical devices-<br>Part 23: Tests for<br>irritation and skin<br>sensitization | Under the<br>conditions of the<br>study, the subject<br>device non-polar<br>and polar extracts<br>were determined to<br>be non-irritating. | Pass | ## 9. Summary of Clinical Performance Test {10}------------------------------------------------ No clinical study is included in this submission. ## 10. Final Conclusion The subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210622.