UNIWEB Surgical Mask, Model: ASTM Level 1, UNIWEB Surgical Mask, Model: ASTM Level 2

{0}------------------------------------------------ Image /page/0/Picture/0 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 blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. September 29, 2021 Universal Incorporation % Tyra Chiu Regulatory Consultant VOLER Biotech Consulting Co., Ltd. 1 Ft, No 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei, 72548 Taiwan Re: K210513 Trade/Device Name: UNIWEB Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2021 Received: August 31, 2021 Dear Tyra Chiu: 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 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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K210513 Device Name UNIWEB Surgical Mask The Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for Adult use Only. The UNIWEB Surgical Masks are 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 Date September 29, 2021 | Manufacturer/ | UNIVERSAL INCORPORATION<br>10F., No.372 Linsen N. Rd.,Zhongshan Dist.,Taipei City<br>10446,Taiwan | |----------------------|---------------------------------------------------------------------------------------------------| | Contact Person | Mei-Hui Huang<br>Phone: +886-2-25119161<br>E-mail: uk@uk.com.tw | | Device Trade Name | UNIWEB Surgical Mask | | Common Name | Surgical Masks | | Classification Name | Masks, Surgical | | Device Class | II | | Classification Panel | General & Plastic Surgery | | Regelation Number | 878.4040 | | Product Code | FXX | | Device Description | UNIWEB SURGICAL MASK are 3-layer surgical masks | that covers and Technology the user's nose and mouth and provides a physical barrier to fluids Characteristics and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer and middle layer, and is provided with ear loops and nose wire for individualized fit. > Models ASTM Level 1, ASTM Level 2 - The Surqical Mask is intended to be worn to protect both the Indications for Use patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. This device is intended for adult use Only. The UNIWEB Surgical Masks are single use, disposable device, provided non-sterile. Predicate Device(s) K141085 WestTec Procedure Facemask, WestTec Surgical Facemask/ WESTTEC, LLC | | Proposed Device | Predicate Device | Comparison | |---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Device Name | UNIWEB Surgical Mask | WestTec Procedure Facemask,<br>WestTec Surgical Facemask | - | | 510(k) # | K210513 | K141085 | - | | Applicant | Universal Incorporation | WESTTEC, LLC | - | | Product code | FXX (21 CFR 878.4040) | FXX (21 CFR 878.4040) | Same | | Classification | II | II | Same | | OTC use | YES | YES | Same | | Intended Use | The Surgical Mask is intended<br>to be worn to protect both the<br>patient and healthcare<br>personnel from the transfer of<br>microorganisms, body fluids<br>and particulate material. This<br>device is intended for adult use<br>Only. The UNIWEB Surgical<br>Masks are single use,<br>disposable device, provided<br>non-sterile. | WestTec Procedure and<br>Surgical facemasks are<br>intended to be worn by<br>healthcare workers to protect<br>the user and patient against<br>transfer of microorganisms,<br>blood and body fluids, and<br>airborne particulates. The<br>WestTec Procedure and<br>Surgical facemasks are single<br>use, disposable devices<br>provided non-sterile. | Same | | Dimensions | 175 mm x 95 mm | 175 mm x 90 mm | Similar | | Layers | Three | Three | Same | | Mask Style | Flat-pleated | Flat-pleated | Same | | Design Feature | Ear loops | Ear loops | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Use | Single Use | Single Use | Same | | Material: | Surface Layer: Polypropylene<br>Spunbond<br>Middle Layer: Polypropylene<br>Meltblown<br>Bottom Layer: Polypropylene<br>Spunbond<br>Nose Wire: galvanized iron<br>wire covered with polyethylene<br>Ear Loops: Nylon and Spandex | Outer Layer: spunbond<br>polypropylene.<br>Middle Layer: meltblown<br>polypropylene filter media.<br>Inner Layer: spunbond<br>polypropylene.<br>Earloops are soft non natural<br>rubber latex,elastic loops.<br>Nose Band: steel wires<br>encased in polyethylene | similar | | Fluid Resistance<br>(ASTM F1862) | Pass at 80 mmHg,<br>Pass 120 mmHg | Pass at 120 mmHg | Same | | Bacterial Filtration<br>Efficiency (ASTM F2101) | ≥ 99.8 % | 99.7 % | Same. Meet Level 2<br>requirement | | Differential Pressure<br>(Mil-M-36954C) | $3.6{\sim}4.2$ mmH2O/cm² | $3.3{\sim}3.6$ mmH2O/cm² | Same. Meet Level 2<br>requirement | | Particle Filtration<br>Efficiency<br>(ASTM F2299) | $99.74{\sim}99.95$ % (at 0.1<br>microgram) | 98 % | Same. Meet Level 2<br>requirement | | Flammability<br>(16 CFR 1610) | Class I | Class I | Same | | Biocompatibility<br>(ISO 10993-5, -10) | Non-Cytotoxic, Non-<br>Sensitizing, Non-Irritating | Non-Cytotoxic, Non-<br>Sensitizing, Non-Irritating | Same | ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE {4}------------------------------------------------ ## Discussion on Performance Data Non-Clinical Tests The proposed devices were tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission. {5}------------------------------------------------ ## Non-Clinical Testing Summary: | Test Methodology | Purpose of the test | F2100-19<br>Level 1<br>Requirement | F2100-19<br>Level 2<br>Requirement | UNIWEB<br>Surgical Mask<br>Test Result<br>Level 1 | UNIWEB<br>Surgical Mask<br>Test Result<br>Level 2 | |--------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|----------------------------------------------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------| | Bacteria Filtration<br>Efficiency | Determine the bacterial<br>filtration efficiency as<br>directed in Test Method<br>ASTM F2101. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)<br>passed at ≥<br>99% | 96/96 (3 lots)<br>passed at ≥<br>99% | | Particle Filtration<br>Efficiency | Determine particulate<br>filtration efficiency as<br>directed in Test Method<br>F2299. | ≥ 95 % | ≥ 98 % | 96/96 (3 lots)<br>passed at ≥<br>99% | 96/96 (3 lots)<br>passed at ≥<br>99% | | Differential<br>Pressure (Delta-P) | Determine breathing<br>resistance or differential<br>pressure as directed in<br>EN 14683:2019, Annex<br>C. | <5.0<br>mmH2O/cm² | <6.0<br>mmH2O/cm² | 96/96 (3 lots)<br>show 3.6~4.2<br>H2O/cm²<br>, pass at <5.0<br>H2O/cm² | 96/96 (3 lots)<br>show 3.6~4.2<br>H2O/cm², pass<br>at <6.0<br>H2O/cm² | | Resistance to<br>penetration by<br>synthetic blood,<br>minimum pressure<br>in mm Hg for pass<br>result | Determine synthetic<br>blood penetration<br>resistance as specified<br>in Test Method F1862 | 80 mmHg<br>(≥ 29/32 show<br>passing results<br>per lot) | 120 mmHg<br>(≥ 29/32 show<br>passing results<br>per lot) | 96/96 (3 lots)<br>passed at 80<br>mmHg | 95/96 (3 lots)<br>passed at 120<br>mmHg | | Flammability | Determine flammability<br>as specified in 16 CFR<br>Part 1610 | Class I<br>(Burn time ≥3.5<br>s, IBE, or DNI) | Class I<br>(Burn time ≥3.5<br>s, IBE, or DNI) | 96/96 (3 lots)<br>show IBE,<br>passed at class I | 96/96 (3 lots)<br>show IBE,<br>passed at<br>class I | ## Biocompatibility Testing Summary: | Test Methodology | Purpose of the test | Acceptance Criteria | Test Results | |-------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------|--------------| | In vitro Cytotoxicity<br>test | Determine the effects on cells<br>following ISO 10993-5 | Cell viability of 100%<br>test article extract is ≥<br>70% of control group | Passed. | | Skin sensitization Test | Estimate the potential for contact<br>sensitization following ISO 10993-10 | Grades =0 | Passed. | | Skin Irritation Test | Estimate the irritation potential of<br>medical device following ISO 10993-<br>10 | Mean score 0~0.4<br>(Negligible) | Passed. | A shelf-life evaluation was conducted, and the test results demonstrate that the device maintain its performance in its claimed 3-year shelf life. Discussion on Not applicable Clinical Test Performed The subject device has same indications for use, technology, {6}------------------------------------------------ operation principle and technical characteristics with the predicate device(s). Verification activities were performed on subject device and all tests were verified to meet the required acceptance criteria. The non-clinical tests demonstrate that the differences in the devices do not affect the indications for use of the device or raise any unsolved issues. There are no significant differences between subject device and the predicate device(s) that would adversely affect the use of the product. - Conclusion The conclusions drawn from the non-clinical tests demonstrate that the subject device, UNIWEB Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device, K141085, WestTec procedure facemask.