Banyan USA Surgical Mask Level 3

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September 22, 2021 Banyan USA LLC % Timothy Kania Consultant MDI Consultants Inc. 55 Northern Blvd. Suite 200 Great Neck, New York 11021 Re: K211097 Trade/Device Name: Banyan USA Surgical Mask Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 13, 2021 Received: August 17, 2021 Dear Timothy Kania: 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 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 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) K211097 Device Name Banyan USA Surgical Mask Level 3 Indications for Use (Describe) The Banyan USA Surgical Mask Level 3 is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganism, body fluids, and particulate materials. This face mask are intended for use in infection control practices to reduce potential exposure to blood and body fluids. the face mask is single use, disposable device, provided non-sterile. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| | | Prescription Use (Part 21 CFR 801 Subpart D) > 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 The assigned 510(k) number is: K211097 ### 1. Submitter's Identification: Manufacturer: Banyan USA, LLC Address: 390 Oser Avenue Hauppauge, NY 11788 Contact: Mr. Ricardo Ryan Title: VP of Operations Phone Number: 631-456-5447 Email: rryan@banyanppe.com Date Summary Prepared: March 31, 2021 Official Correspondent: Mr. Tim Kania mdi Consultants, Inc. Phone Number: (732)-796-4565 Email: tim(@mdiconsultants.com ## 2. Name of the Device: | Device Name(s): | Banyan USA Surgical Mask Level 3 | |-----------------|----------------------------------| | Model Number: | M3WH | Common Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX #### 3. Information for the 510(k) Cleared Device (Predicate Device): ### Predicate Device: 3-ply EcoGuard B with Earloop K202096 EcoGuard Inc. #### 4. Device Description: The Banyan USA Surgical Mask is composed of three-layers which are flat-pleated and ultrasonically welded together at the edges of the mask at embossment points. The mask materials consist of an outer layer (polypropylene spunbond, white), filter layer (polypropylene melt-blown, white) and inner layer web (polypropylene thermal-bonded, white (22 GSM Thermal Bond White Material)). Each mask has two ear loops ultrasonically welded onto the sides to secure the users' nose and mouth. The construction also includes a polyethylene wire nosepiece to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile. {4}------------------------------------------------ ### 5. Indications for Use: The Banyan USA Surgical Mask Level 3 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 potential exposure to blood and body fluids. The face mask is single use, disposable device, provided non-sterile. ### 6. Comparison to the 510(k) Cleared Devices (Predicate Devices): | Item | Proposed Device: | Predicate Device: | Comparison | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | 510(k) Number | K211097 | K202096 | - | | Manufacturer | Banyan USA, LLC | EcoGuard Inc. | - | | Product Name | Banyan USA Surgical Mask Level 3 | 3-ply EcoGuard B with Earloop | Different | | Model Number | M3WH | ECO01 | Different | | Classification | Class II Device Product Code: FXX Regulation Number: 21 CFR 848.4040 | Class II Device Product Code: FXX Regulation Number: 21 CFR 848.4040 | Same | | Intended Use/Indications for Use | The Banyan USA Surgical Mask Level 3 are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These surgical masks are single use and disposable. Provided non-sterile. | The following EcoGuard Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These surgical masks are single use, disposable devices provided non-sterile. | Same | | Material | | | | | Outer Facing Layer | Spunbond polypropylene | Spunbond polypropylene | Similar | | Middle Layer | Melt blown polypropylene | Melt blown polypropylene | Similar | | Inner Facing Layer | Thermal bonded polypropylene (22 GSM Thermal Bond White Material) | Spunbond polypropylene | Different | | Nose Piece | Polyethylene Nose Wire | Malleable Polyethylene Wire | Different | | Table 2: Comparison to Predicate Device | | |-----------------------------------------|--| | | | {5}------------------------------------------------ | Ear Loops | White Knitted Nylon Elastic | Polyester Nylon/Spandex | Different | |---------------------------------|-------------------------------------------------------------------|-------------------------------------------------------------------------|-----------| | Mask Style | Flat Pleated | Flat Pleated | Similar | | Color | White<br>Colorant: None<br>CAS#: None | Blue<br>Colorant: Pigment Blue 15:3<br>CAS#: 147-18-8 | Different | | | Design Features | | | | Specification and<br>Dimensions | $6.9 \pm \frac{1}{4}"$<br>$3.7 \pm \frac{1}{4}"$ | $17.5cm \pm 2.0cm$<br>(~6.9 ±0.4")<br>$9.5cm \pm 2.0cm$<br>(~3.7 ±0.4") | Similar | | OTC Use | Yes | Yes | Same | | Single Use | Yes | Yes | Same | | Sterility | Non-Sterile | Non-Sterile | Same | | Use | Single use, Disposable | Single Use, Disposable | Same | | ASTM F2100<br>Level | Level 3 | Level 3 | Same | | Non-Clinical<br>Testing | ASTM F1862<br>ASTM F2299<br>ASTM F2101<br>EN 14683<br>16 CFR 1610 | ASTM F1862<br>ASTM F2299<br>ASTM F2101<br>MIL-M-36954C<br>16 CFR 1610 | Same | | Biocompatibility<br>Testing | Cytotoxicity<br>Irritation<br>Sensitization | Cytotoxicity<br>Irritation<br>Sensitization | Same | ### Summary of Non-Clinical Tests: 7. The Banyan USA Surgical Mask Level 3 has been tested in accordance with the ASTM F2100-11 Standard Specification for Performance of Materials Used in Medical Face Masks. See Table 3 below for a summary of the non-clinical test results. | Test | Purpose | Acceptance Criteria per<br>ASTM F2100-11 Level 3<br>(AQL = 4.0%) | Proposed Device Test Result:<br>Banyan USA Surgical Mask | | |------------------------------------------------------|-----------------------------------------------------------|------------------------------------------------------------------|------------------------------------------------------------------------|---------| | | | | ASTM F2100-11 Level 3 | Average | | Fluid Resistance<br>Performance<br>(ASTM F1862) | Determine<br>synthetic blood<br>penetration<br>resistance | 160 mmHg | Pass at 160 mmHg (96/96)<br>32 Samples from 3 non-<br>consecutive lots | N/A | | Particulate<br>Filtration Efficiency<br>(ASTM F2299) | Determine<br>bacterial<br>filtration<br>efficiency | ≥ 98% | Pass (96/96) 32 Samples<br>each from 3 non-<br>consecutive lots | 98.69% | Table 3: Summary of Non-Clinical Testing {6}------------------------------------------------ | Bacterial Filtration<br>Efficiency<br>(ASTM F2101) | Determine<br>submicron<br>particulate<br>filtration<br>efficiency | $\geq$ 98 % | Pass (96/96) 32 Samples<br>each from 3 non-<br>consecutive lots | 99.22% | |-----------------------------------------------------|---------------------------------------------------------------------|-------------------|-------------------------------------------------------------------------|--------------------| | Differential<br>Pressure (Delta P)<br>EN 14683:2019 | Determine<br>breathing<br>resistance or<br>differential<br>pressure | < 6.0 mmH2O / cm2 | Pass (96/96) 32 Samples<br>each from 3 non-<br>consecutive lots | 3.82 mm<br>H20/cm2 | | Flammability<br>CFR 16 1610 | Determine<br>flammability | Class 1 | Class 1 Pass (96/96) 32<br>Samples each from 3 non-<br>consecutive lots | N/A | ## Table 4: Summary of Biocompatibility Testing | Biocompatibility<br>ISO 10993-I Evaluation and testing within a risk management process | | | | | |-----------------------------------------------------------------------------------------|---------------------------------------------------------------------|-------------------------------------------|--|--| | Test | Test Findings | Result | | | | Cytotoxicity<br>ISO 10993-5 Tests for in vitro<br>cytotoxicity of medical devices | Under the conditions of the study, the<br>device is non-cytotoxic | Banyan USA Surgical<br>Mask Level 3 :Pass | | | | Irritation<br>ISO 10993-10 Tests for irritation | Under the conditions of the study, the<br>device is non-irritating | Banyan USA Surgical<br>Mask Level 3: Pass | | | | Sensitization<br>ISO 10993-10 Tests for skin<br>sensitization | Under the conditions of the study, the<br>device is non-sensitizing | Banyan USA Surgical<br>Mask Level 3:Pass | | | ### 8. Summary of Clinical Test: NA #### 9. Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the proposed device, the Banyan USA Surgical Mask Level 3, is as safe, as effective, and performs as well as or better than the legally marketed predicate device K202096.