3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3

Q: Who is the manufacturer of 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3?

3A Medical Products Co., Ltd. filed the 510(k) submission for 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 (K202598).

Q: What is the FDA product code for 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3?

FXX. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3?

510(k) clearance (submission type: Traditional).

Q: What are the predicate devices for 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3?

Surgical Face Masks (Ear Loops and Tie On) (K160269).

Q: Who can help prepare an FDA 510(k) submission like 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K202598 · 3A Medical Products Co., Ltd. · FXX · May 6, 2021 · General, Plastic Surgery

Device Facts

Record ID	K202598
Device Name	3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3
Applicant	3A Medical Products Co., Ltd.
Product Code	FXX · General, Plastic Surgery
Decision Date	May 6, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

This mask is intended to be worn to protect both the patient and healthcare worker from transfer of microorganisms, body fluid and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use device and is provided non-sterile.

Device Story

3-layer flat-pleated surgical masks; available in Level 1, 2, and 3 barrier protection; constructed of 100% nonwoven polypropylene; features malleable nose strip for fit; secured via polyester/spandex ear loops or polypropylene ties. Intended for single-use in clinical settings to provide barrier protection against microorganisms, body fluids, and particulates. Protects both patient and healthcare worker. Non-sterile.

Clinical Evidence

Bench testing only. Performance evaluated against ASTM F2100 standards: Fluid Resistance (ASTM F1862), Particulate Filtration Efficiency (ASTM F2299), Bacterial Filtration Efficiency (ASTM F2101), Differential Pressure (EN14683), and Flammability (16 CFR 1610). Biocompatibility testing conducted per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (irritation and sensitization). All results met acceptance criteria for respective barrier levels.

Technological Characteristics

Materials: 100% nonwoven polypropylene (outer/inner layers, filter media), polyethylene-coated steel wire (nose strip), polyester/spandex or polypropylene (ear loops/ties). Dimensions: 9.5cm x 17.5cm. Standards: ASTM F2100 (Level 1-3), ASTM F1862, ASTM F2299, ASTM F2101, EN14683, 16 CFR 1610, ISO 10993. Form factor: Flat-pleated. Non-sterile.

Indications for Use

Indicated for use by patients and healthcare workers to protect against microorganisms, body fluids, and particulate material in infection control practices to reduce exposure to blood and body fluids.

Regulatory Classification

Identification

Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded.

Special Controls

*Classification.* (1) Class II (special controls) for surgical gowns and surgical masks. A surgical N95 respirator or N95 filtering facepiece respirator is not exempt if it is intended to prevent specific diseases or infections, or it is labeled or otherwise represented as filtering surgical smoke or plumes, filtering specific amounts of viruses or bacteria, reducing the amount of and/or killing viruses, bacteria, or fungi, or affecting allergenicity, or it contains coating technologies unrelated to filtration (e.g., to reduce and or kill microorganisms). Surgical N95 respirators and N95 filtering facepiece respirators are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9, and the following conditions for exemption:(i) The user contacting components of the device must be demonstrated to be biocompatible. (ii) Analysis and nonclinical testing must: (A) Characterize flammability and be demonstrated to be appropriate for the intended environment of use; and (B) Demonstrate the ability of the device to resist penetration by fluids, such as blood and body fluids, at a velocity consistent with the intended use of the device. (iii) NIOSH approved under its regulation. (2) Class I (general controls) for surgical apparel other than surgical gowns and surgical masks. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 878.9.

Predicate Devices

Surgical Face Masks (Ear Loops and Tie On) (K160269)

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Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a human figure, and the text is written in blue. The logo is used to identify the FDA, which is a federal agency responsible for regulating and supervising the safety of food, drugs, and other products. March 3, 2022 3A Medical Products Co., Ltd Mary Mejaes Consultant Yu An Industrial Park 230001 Liu An, Anhui China Re: K202598 Trade/Device Name: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3, 3 Layer Surgical Marks with Ties Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dear Mary Mejaes: The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 6, 2021. Specifically, FDA is updating this SE Letter for a missing trade name as an administrative correction. Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Clarence W. Murray III, PhD., OHT4: Office of Surgical and Infection Control Devices, 301-796-0270, clarence.murray@fda.hhs.gov. Sincerely, # Liqun Zhao -S 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. Underneath the square, the words "U.S. Food & Drug Administration" are written in blue. May 6, 2021 3A Medical Products Co., Ltd Marv Meiaes Consultant Yu An Industrial Park 230001 Liu An, Anhui China Re: K202598 Trade/Device Name: 3 Layer Surgical Mask with Ear Loops Level 1, 3 Layer Surgical Mask with Ties Level 1, 3 Layer Surgical Mask with Ear Loops Level 2, 3 Layer Surgical Mask with Ties Level 2, 3 Layer Surgical Mask with Ear Loops Level 3 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 20, 2021 Received: March 1, 2021 Dear Mary Mejaes: 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. {2}------------------------------------------------ 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 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(@tda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Ryan Ortega -S Ryan Ortega, PhD Acting 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 {3}------------------------------------------------ #### Indications for Use 510(k) Number (if known) k202598 #### Device Name 3 Layer Surgical Mask with Ear Loops, Level 1 3 Layer Surgical Mask with Ear Loops, Level 2 3 Layer Surgical Mask with Ear Loops, Level 3 3 Layer Surgical Mask with Ties, Level 1 3 Layer Surgical Mask with Ties, Level 2 3 Layer Surgical Mask with Ties, Level 3 #### Indications for Use (Describe) This mask is intended to be worn to protect both the patient and healthcare worker of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use 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." {4}------------------------------------------------ #### 510(k) Summary # Date of Summary Preparation: April 29, 2021 Type of 510K: Traditional 510K Number: K202598 | 1. Applicant: | 3A Medical Products Co., Ltd. | |----------------|---------------------------------------------------------------------------------------| | Address: | Yu An Industrial Park, 230001 Liu An, Anhui Province People's Republic of China | | Tel No. | 86-564-3611700 | | Fax No. | 86-5643611700 | | Email Address: | info@3a-medical.cn | | Consultant: | Mary Mejaes | #### 2. Proprietary Device Name - 3 Layer Surgical Mask with Ear Loops: Level 1 Level 1 3 Layer Surgical Mask with Ties: 3 Layer Surgical Masks with Ear Loops: Level 2 3 Layer Surgical Masks with Ties: Level 2 3 Layer Surgical Masks with Ear Loops: Level 3 3 Layer Surgical Masks with Ties: Level 3 #### Regulatory Information: 3. Classification Name: Surgical Face Masks/Apparel Classification: Class II Product Code: FXX Regulation No. 21 CFR 878.4040 #### 4. Predicate Device: 510K Number: K160269 Manufacturer: SAN-M Package Co., Ltd. Device Name: Surgical Face Masks (Ear Loops and Tie On) {5}------------------------------------------------ #### 5. Indications for Use/Intended Use: This mask is intended to be worn to protect both the patient and healthcare worker from transfer of microorganisms, body fluid and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use device and is provided non-sterile. #### 6. Device Description: These 3 Layer Surgical Masks: Level 1, Level 2 or Level 3 (with Ear Loops or Ties) are 3 layer, flat-folded masks constructed of 100% nonwoven polypropylene materials. The masks are provided with Ear Loops (Polyester/Spandex) or Ties (Polypropylene). A malleable nose strip is placed within the binding for comfort and individualized fit. These masks meet the acceptance criteria for ASTM F 2100, Level 1, Level 2 or Level 3 performance standards and are provided in blue. These masks are single use and provided non-sterile. #### 3 Layer Surgical Masks Model Numbers | Barrier Levels | Ear Loops | Ties | |----------------|------------|------------| | Level 1 | Ref: 1000E | Ref: 1000T | | Level 2 | Ref: 2000E | Ref: 2000T | | Level 3 | Ref: 3000E | Ref: 3000T | #### Table A, Model Nos. {6}------------------------------------------------ # 7. Comparison of Technological Characteristics | Feature | Proposed Device Surgical Masks with Ear Loops or Ties, Level 1, Level 2, Level 3 | Predicate Device Surgical Face Masks Ear Loops and Tie-on Level 1, Level 2 and Level 3 | Comparison of Characteristics Remarks | |----------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------| | 510 (k) No | K202598 | K160269 | - | | Manufacturer | 3A Medical Products Co., Ltd | San-M Package Co. Ltd | - | | Common Name | Surgical Mask | Surgical Mask | Identical | | Classification | Class II | Class II | Identical | | Product Code | FXX | FXX | Identical | # Table B, Comparison of Characteristics {7}------------------------------------------------ | Indications for Use | | | | |---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------| | | This mask is intended to be worn to protect both the patient and healthcare worker from the transfer of microorganisms, body fluids and particulate material. This mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use device provided non- sterile. | The surgical face masks are 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 provided non- sterile. | Same | {8}------------------------------------------------ | Outer Layer | Polypropylene | Polypropylene | Similar | |----------------|-----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------| | | | | Please see Note 1 | | Inner Layer | Polypropylene | Polypropylene | Similar | | | | | Please see Note 1 | | Filter Media | 1. Polypropylene Spunbond 2.Polypropylene Meltblown | 1. Polypropylene Spunbond 2.Polypropylene Meltblown | Similar Please see Note 1 | | Nose Strip | Polyethylene coated Steel Wire | Polyethylene coated Steel Wire | Same | | Ear Loop/Ties | Ear Loops: Polyester/Spandex Ties: Polypropylene Spunbond | Ear Loop: Polyester, Polyurethane Ties Polypropylene Spunbond or Polyester Spunbond | Similar | | Color | Blue | White or Blue | Similar | | Dimensions | $9.5\pm1cm$ x $17.5 cm \pm1$ cm | $95 \pm3mm$ x $175\pm5mm$ , $90\pm3mm$ x 180mm | Similar | | Mask Style | Flat Pleated | Flat Pleated | Same | | Sterility | Non-Sterile | Non-Sterile | Same | Note 1: The outer layer, inner layer and filter media of the proposed devices have the same material content but with different weights in order to meet the safety and effectiveness of each barrier level. They still meet the requirements of essential performance standard ISO 10993. The proposed device under this premarket notification submission 510(k) K202598 is the same or similar in design, indications for use, technological characteristic and is composed of the same or similar components as the predicate device 510(k) K160269. {9}------------------------------------------------ ### 8. Summary of Non-Clinical Testing | | Proposed Device Surgical Masks with Ear Loops or Ties Level 1, Level 2, Level 3 | Predicate Device Surgical Face Masks Ear Loops and Tie-on Level 1, Level 2,Level 3 | |--------------------------------------|------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | Fluid Resistance | ASTM F 1862F/1862M- 2017 | ASTM F1862 | | Particulate Filtration Efficiency | ASTM F 2299/F2299M- 2003(2017) | ASTM F2299 | | Bacteria Filtration Efficiency | ASTM F2101:2019 | ASTM F2101 | | Differential Pressure | EN14683:2019 +AC2019 (E) Annex C | MIL-M36945C | | Flammability | 16 CFR 1610: 2019 | 16 CFR 1610 | | Biocompatibility | ISO10993-5:2009 ISO 10993-10:201 | ISO 10993 | #### Table C, Test Methods Used # Table D, Performance Testing | Test Methods | Proposed Device Surgical Masks (Ear Loops or Ties) | | | Predicate Device Level 1 | Predicate Device Level 2 | Predicate Device Level 3 | Comparison | |--------------------------------------------------------|----------------------------------------------------|------------------------|-------------------------|--------------------------|--------------------------|--------------------------|------------| | ASTM F2100 | Level 1 | Level 2 | Level 3 | Level 1 | Level 2 | Level 3 | Same | | ASTM F1862 | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Pass at 80 mmHg | Pass at 120 mmHg | Pass at 160 mmHg | Same | | ASTM 2299 | Pass at 98.86% | Pass at 98.8% | Pass at 98.6% | Pass at 99.6% | Pass at 99.6% | Pass at 99.7% | Similar | | ASTM F2101 | Pass at 99.9% | Pass at 99.9% | Pass at 99.9% | Pass at >98% | Pass at >98% | Pass at >99% | Similar | | EN14683 for proposed and Mil-M26945C for the predicate | Pass at 4.1 mm H2O/cm² | Pass at 4.0 mm H2O/cm² | Pass at 4.53 mm H2O/cm² | Pass at 2.0mm H2O/cm² | Pass at 1.6mm H2O/cm² | Pass at 2.5mm H2O/cm² | Similar | {10}------------------------------------------------ | | Proposed Device Levels 1, 2 and 3 | | | Predicate Device Level 1, 2 and 3 | Comparison | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|------------| | 16 CFR 1610 | Class 1 | .Class 1 | Class 1 | Class 1 | Same | | Cytotoxicity ISO 10993-5:2010 | Under the conditions of this study the test article have no potential toxicity to L929 cells | Under the conditions of this study the test article have no potential toxicity to L929 cells | Under the conditions of this study the test article have no potential toxicity to L929 cells | Under the conditions of the study the subject device was non- cytotoxic. | Similar | | Irritation ISO10993- 10:2010 | Under the experimental conditions the test article has no potential skin irritation on rabbits in the extraction method. | Under the experimental conditions the test article has no potential skin irritation on rabbits in the extraction method. | Under the experimental conditions the test article has no potential skin irritation on rabbits in the extraction method. | Under the conditions of the study the subject device was non- irritating. | Similar | | Sensitization ISO 10993- 10:2010 | Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the extraction method | Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the extraction Method | Under the experimental conditions, the test article has no potential skin sensitization on guinea pigs in the extraction method | Under the conditions of the study the subject device was non- sensitizing. | Similar | # Table E, Flammability and Biocompatibility Testing Results {11}------------------------------------------------ The proposed models under this premarket notification submission have similar performance characteristics and conform to the same Recognized Consensus Standards. These standards include testing that covers Bacterial Filtration Efficiency, Particulate Filtration Efficiency, Fluid Resistance, Flammability, Differential Pressure (Breathability) and Biocompatibility. Differences between the Proposed 3 Layer Surgical Masks (Ear Loop and Tie on) and the predicate devices did not raise any new concerns regarding safety and effectiveness. Both meet the Recognized Consensus Standards acceptance criteria. #### 9. Conclusion The conclusion drawn from the non-clinical tests demonstrate that the subject device in 510(k) submission K202598, 3 Layer Surgical Masks with Ear Loops or Ties, Level 1, Level 2, and Level 3 is as safe and effective and performs as well or better than the legally marketed predicate device cleared under 510(k) K160269.