039 Surgical 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, there is a symbol representing the Department of Health & Human Services - USA. To the right of this symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue. November 23, 2021 AOK Tooling Limited % Paul Dryden Consultant AOK Tooling Limited % ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704 Re: K211956 Trade/Device Name: 039 Medical Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 19, 2021 Received: October 22, 2021 Dear Paul Dryden: 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, For Clarence W. Murray, III, PhD 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) #### K211956 Device Name ## 039 Medical Surgical Face Mask Indications for Use (Describe) The 039 Medical Surgical Face Mask is 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) XX_ 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 respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ #### 510(k) Summary Page 1 of 5 ### Date Prepared: 21-Nov-2021 AOK Tooling Limited # 101 And 1Building, 2Building, 3Building, 4Building, 5Building NO. 8 Of Long Tian No. 3 Road, Long Tian Community, Long Tian Street, Ping Shan District Shen Zhen, China 518122 Tel - +852-0-23101703 | Sponsor Contact: | Francis Nithyananthan<br>Project Director | |----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Submission Correspondent: | Paul Dryden<br>ProMedic Consulting LLC | | Proprietary or Trade Name: | 039 Medical Surgical Face Mask | | Common/Usual Name: | Mask, Surgical | | Classification Name: | Product Code - FXX – Mask, Surgical | | Predicate Devices: | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. -<br>K202605 | | Device Description: | The 039 Medical Surgical Face Mask is single use, four-<br>layer folded masks with ear loops, or straps to tie behind<br>the user's head, and a nose piece. The ear loops are held<br>in place over the users' mouth and nose by two elastic<br>ear loops welded to the facemask. The elastic ear loops<br>are not made with natural rubber latex. The nose piece in<br>the layers of facemask is to allow the user to fit the<br>facemask around their nose, which is made of malleable<br>polyethylene wire. The surgical face masks will be<br>provided in blue. The 039 Surgical Face Mask is sold<br>non-sterile and are intended to be single use, disposable<br>devices. | | Principle of Operation: | A surgical mask covers the user's nose and mouth and<br>provides a physical barrier to fluids and particulate<br>materials. | | Indications for Use: | The 039 Medical Surgical Face Mask are intended to be<br>worn to protect both the patient and healthcare personnel<br>from transfer of microorganisms, body fluids and<br>particulate material. These face masks are intended for<br>use in infection control practices to reduce the potential<br>exposure to blood and body fluids. This is a single use,<br>disposable device(s), provided non-sterile. | {4}------------------------------------------------ ### 510(k) Summary Page 2 of 5 | Description | Predicate Device | Proposed Device | Comparison | |----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------| | Manufacturer | Jiangsu Medplus Non-woven Manufacturer Co., Ltd. | AOK Tooling Ltd. | | | 510(k) Number | K202605 | K211956 | | | Model Name | Standard Procedure Mask, Standard Surgical Mask | 039 Medical Surgical Face Mask | | | Classification | Class II Device<br>FXX<br>21 CFR878.4040 | Class II Device<br>FXX<br>21 CFR878.4040 | Identical | | Intended use /<br>Indications for Use | The device is intended to be worn to protect both the<br>patient and healthcare personnel from transfer of<br>microorganisms, body fluids and particulate material.<br>These face masks are intended for use in infection<br>control practices to reduce the potential exposure to<br>blood and body fluids. This is a single use, disposable<br>device, provided non-sterile. | The 039 Medical Surgical Face Mask are intended<br>to be worn to protect both the patient and<br>healthcare personnel from transfer of<br>microorganisms, body fluids and particulate<br>material. These face masks are intended for use in<br>infection control practices to reduce the potential<br>exposure to blood and body fluids. This is a single<br>use, disposable device(s), provided non-sterile. | Identical | | Mask Style | Flat pleated | Folded | The mask style is<br>different, but<br>performance is similar to<br>the predicate* | | Materials | | | | | Cover Fabric(s) | Spunbonded nonwoven and Melt blown nonwoven<br>fabric | Non-woven polypropylene; Melt blown non-<br>woven polypropylene filter | The difference does not<br>impact device<br>performance* | | Nose Piece | Plastic | Silicone | The difference does not<br>impact device<br>performance* | | Ear Loops / Tie-on | Polyester and spandex and<br>Spunbonded nonwoven | Spandex | Identical | | Color | Blue | Blue and White | Similar | | Design | Ear loop and tie-on | Ear loop and tie-on | Identical | | Dimension (Width /<br>Length) Flat even though<br>subject device is folded | 175×95 mm | Small - 208x111 mm<br>Medium - 226x124 mm<br>Large - 250x138 mm<br>Xlarge - 262x144 mm | The size difference does<br>not impact device<br>performance* | | OTC Use | Yes | Yes | Identical | | Use | Single Use, Disposable | Single Use, Disposable | Identical | | ASTM 2100 Level | Level 2 | Level 2 | Identical | | Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Identical | | Particulate efficiency level | ≥98% | ≥98% | Identical | | Bacterial filtration level | ≥98% | ≥98% | Identical | | Differential pressure | <6.0 mm H2O/cm2 | <6.0 mm H2O/cm2 | Identical | | Flammability | Class I | Class I | Identical | | Biocompatibility Tested | Cytotoxicity<br>Sensitization<br>Irritation | Cytotoxicity<br>Sensitization<br>Irritation | Identical | | Sterility | Non-sterile | Non-sterile | Identical | {5}------------------------------------------------ ### 510(k) Summary Page 3 of 5 {6}------------------------------------------------ #### 510(k) Summary Page 4 of 5 #### Indications for Use - The indications for use are identical for the proposed device when compared to the predicate - Discussion - Each device is indicated to cover a user's nose and mouth and provides a physical barrier to fluids and particulate materials. #### Technology and construction - The design, fabrication, shape, size, etc. are equivalent to the predicate - Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605. Discussion - This mask is not a flat-pleated style and covers a larger surface area of the user's face. However, the difference in mask style of flat pleated vs. folded should not impact the substantial equivalence of the subject device to the predicate. Our testing demonstrated that the subject device has similar performance to the predicate. ### Environment of Use - The environments of use are identical to predicate - Jiangsu Medplus Non-woven Manufacturer Co., Ltd. - K202605. Discussion - The environments of use are the same. ## Patient Population - The patient population of the proposed device and predicate - Jiangsu Medplus Nonwoven Manufacturer Co., Ltd. - K202605. Discussion - The identified patient population is equivalent to the predicate. ## Non-Clinical Testing Summary - Performance testing was performed following ASTM F2100-2019 Standard Specification for Performance of Materials Used in Medical Face Masks with reference to Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510k] Submission (2004). Three separate non-consecutive lots of 32 samples each were tested. | Test Methodology | Purpose | Acceptance Criteria for<br>Level 2 Barrier | Results | |-------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|------------------------------------------------|----------------------------------| | Section 6.1 Bacterial<br>Filtration Efficiency<br>ASTM F2101 | Measure bacterial<br>filtration efficiency | >98%<br>87 of 96 pass | 99.9%<br>96 of 96 passed | | Section 6.1 Differential<br>Pressure (mm $H_2O/cm^2$ )<br>EN14683:2019+AC:2019<br>Annex C | Determine<br>breathability of a mask | <6.0<br>87 of 96 pass | Average <3.8<br>96 of 96 passed | | Section 6.1 Sub-micron<br>Particulate Filtration<br>Efficiency ASTM<br>F2299/F2299M-03 | Measure initial particle<br>filtration efficiency | ≥98%<br>87 of 96 pass | >99%<br>96 of 96 passed | | Section 6.1 Resistance to<br>Penetration by Synthetic<br>Blood ASTM F1862/F<br>1862M-2017 | Evaluate the resistance<br>to penetration by<br>impact of small volume<br>of synthetic blood | 120 mmHg<br>Visual inspection<br>87 of 96 pass | None seen in<br>91 of 96 samples | | Section 6.2 Flame spread<br>16CFR Part 1610-2008 | Response of materials<br>to heat and flame | Class 1<br>87 of 96 | 96 of 96 passed | {7}------------------------------------------------ #### 510(k) Summary Page 5 of 5 ## Bench testing - We performed the following tests: Fluid Resistance, Flammability, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure. Discussion - The results were similar. #### Biocompatibility - Both devices are considered Surface Contact, Intact Skin, Limited Duration of Use. Discussion - The proposed device materials were found to meet the applicable requirements for biocompatibility safety for the intended population. #### Conclusion: The conclusions drawn from the nonclinical tests demonstrate that the 039 Medical Surgical Face Mask device is as safe, as effective, and performs as well as or better than the legally marketed device in K202605.