LAITEST Medical 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. September 13, 2022 R&R Medical Corporation Ltd. % Chih-Hao Kao Vice President Voler Biotech Consulting Co., Ltd. No. 3-1, Lane 58, Hejiang St., Zhongshan Dist. Taipei City, 10480 Taiwan Re: K214035 Trade/Device Name: LAITEST Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 23, 2022 Received: August 31, 2022 Dear Chih-Hao Kao: 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, 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) K214035 Device Name LAITEST MEDICAL FACE MASK #### Indications for Use (Describe) The LAITEST MEDICAL FACE MASK 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 intection 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) | <input type="checkbox"/> Production Use: Part 21 CFR 601.2, Subpart E | |-------------------------------------------------------------------------------------| | <input checked="" type="checkbox"/> Compassionate Use: Part 21 CFR 601.2, Subpart I | | | 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 [As required by 21 CFR 807.92] # 1. Submission Information | Preparation date: | August 23th, 2022 | |-------------------------|---------------------------------------------------------------------------------------------------------------------------| | Submitter: | R&R Medical Corporation Ltd.<br>No.4, Ln. 38, Zhongxing N. St., Sanchong Dist., New Taipei<br>City 24158, Taiwan (R.O.C.) | | Submitter contact: | Wilson Chang<br>Tel: +886-2-2697-6618/Fax: +886-2-2697-6609<br>E-mail: wcchang@taiwanstanch.com | | Official correspondent: | Chih Hao, Kao<br>Tel: + 886-933852972/Fax: + 886-78419003<br>E-mail: leon.howard01@gmail.com | # 2. Device Name and Classification | Product Name: | LAITEST Surgical Face Mask | |-------------------------------|----------------------------| | Classification Name: | Mask, Surgical | | Common or Usual Name: | Surgical face mask | | Regulation medical specialty: | General & Plastic Surgery | | Regulation Description: | Surgical apparel. | | Review Panel: | General Hospital | | Regulation Number: | 21 CFR 878.4040 | | Device Class: | Class 2 | | Product Code: | FXX | ## 3. Primary Predicate Device(s) | Product Name: | Surgical Face Mask (K182515) | |-----------------------|------------------------------| | Classification: | Class II | | Common or Usual Name: | Surgical face mask | | Classification Panel: | Surgical Apparel | | Regulation Number: | 21 CFR 878.4040 | | Device Class: | Class 2 | | Product Code: | FXX | {4}------------------------------------------------ ## 4. Device Description LAITEST Surgical Face Mask are made of 3-layer non-woven material. The masks have a Bacterial Filtration Efficiency (BFE) and Particle Filtration Efficiency (PFE) Standards of 98%, and Virus Filtration Efficiency (VFE) Standards of 99%, which can effectively protect against sub-micron particles, fine dust, biological agents (bacteria, or viruses), and fluid splashes. The masks have ear loops and nose band which can provide a comfort wear for users. ## 5. Indications for Use The LAITEST 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. {5}------------------------------------------------ # 6. Substantial Equivalence | | Proposed Device | Primary predicate<br>device<br>K182515 | Differences | | |---------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------|-------------| | Item | LAITEST Surgical<br>Face Mask | Surgical Face Mask | NA | | | Classification | 2<br>(21CFR878.4040) | 2<br>(21CFR878.4040) | Same Classification | | | Product Code | FXX | FXX | Same Product Code | | | Indications for Use | The LAITEST<br>Surgical Face Mask<br>are intended to be<br>worn to protect both<br>the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face<br>masks are intended for<br>use in infection<br>control practices to<br>reduce the potential<br>exposure to blood and<br>body fluids. This is a<br>single use, disposable<br>device(s), provided<br>non-sterile. | The Surgical Face<br>Masks are intended to<br>be worn to protect<br>both the patient and<br>healthcare personnel<br>from transfer of<br>microorganisms, body<br>fluids and particulate<br>material. These face<br>masks are intended for<br>use in infection control<br>practices to reduce the<br>potential exposure to<br>blood and body fluids.<br>This is a single use,<br>disposable device(s),<br>provided non-sterile. | Both devices are<br>surgical face mask<br>and have same<br>intended use. | | | Basic design | Ear Loops, Flat<br>Pleated, 3 layers | Ear Loops, Flat<br>Pleated, 3 layers | Same | | | | | Proposed Device | Primary predicate<br>device<br>K182515 | Differences | | Item | | LAITEST Surgical<br>Face Mask | Surgical Face Mask | NA | | | External<br>layer | Spun-bond<br>polypropylene | Spun-bond<br>polypropylene | Same | | Material | Filter<br>layer | Melt blown filter | Melt blown<br>polypropylene filter | Same | | | Inner<br>layer | Spun-bond<br>polypropylene | Spun-bond<br>polypropylene | Same | | Nose band | | PE coating Aluminum<br>Line | Malleable<br>polyethylene wire | Different | | Ear loops | | Nylon + Spandex | Spandex | Similar | | | Color | Blue | Yellow | Different | | Dimension-Width | | 17.5 cm ± 5% cm<br>(0.875 cm) | 17.5cm±0.2cm | Similar | | Dimension-Length | | 9.5 cm±5% cm<br>(0.475 cm) | 9.5cm±0.2cm | Similar | | OTC use | | Yes | Yes | Same | | | Sterility | Non-Sterile | Non-Sterile | Same | | Use | | Single Use,<br>Disposable | Single Use,<br>Disposable | Same | | | ASTM F2100 Level | Level 2 | Level 2 | Same | {6}------------------------------------------------ {7}------------------------------------------------ ## Performance Data ## Non-clinical Test performed on the proposed device 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 issued on March 5, 2004. | Item | Purpose | Proposed device | Acceptance<br>Criteria | Result | |-------------------------------------------------------|------------------------------------------------------------------------|-------------------------------|-------------------------------|--------| | Fluid<br>Resistance<br>Performance<br>ASTM F1862 | Determine<br>synthetic<br>blood<br>penetration<br>resistance | ≥29 of 32 pass at<br>120 mmHg | ≥29 of 32 pass at<br>120 mmHg | Pass | | Particulate<br>Filtration<br>Efficiency<br>ASTM F2299 | Determine the<br>bacterial<br>filtration<br>efficiency | > 98% | ≥ 98% | Pass | | Bacterial<br>Filtration<br>Efficiency<br>ASTM F2101 | Determine<br>submicron<br>particulate<br>filtration<br>efficiency | > 98% | ≥ 98% | Pass | | Differential<br>Pressure<br>(Delta P)<br>EN 14683 | Determine<br>breathing<br>resistance<br>Or<br>differential<br>pressure | <6.0mmH2O/cm² | <6.0mmH2O/cm² | Pass | | Flammability<br>16 CFR Part<br>1610 | Determine<br>flammability<br>flame<br>or<br>spread | Class 1 | Class 1 | Pass | All results of testing met ASTM F2100 Level 2 acceptance criteria {8}------------------------------------------------ | Item | Proposed device | Result | |---------------|----------------------------------------------------------------------|--------| | Cytotoxicity | Under the conditions of the study, the<br>device is noncytotoxic. | Pass | | Sensitization | Under the conditions of the study, the<br>device is non sensitizing. | Pass | | Irritation | Under the conditions of the study, the<br>device is nonirritating. | Pass | Biocompatibility Testing ## Similarity and differences The differences between proposed device and the primary predicate device in materials and colors do not raise additional questions for safety and effectiveness. The proposed device has been tested on safety and performance, and the results were complied with the test requests. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials and color additives. Therefore, the differences did not raise any safety or effectiveness issue. The proposed device is substantially equivalent to the primary predicate device in intended use, design, safety and performance claims. ## Conclusion After analyzing bench test, device description and indication for use, it can be concluded that LAITEST Surgical Face Mask is as safe and effective as the primary predicate device.