PM Excellence SEQUR 100 Surgical Face Mask

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December 15, 2022 PM Excellence LLC Nina Bektic-Marrero Managing Director 2864 Wilson Avenue Bellmore, New York 11710 Re: K220520 Trade/Device Name: PM Excellence SEQUR 100 Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 12, 2022 Received: December 13, 2022 Dear Nina Bektic-Marrero: 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's {1}------------------------------------------------ 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 (OS) 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 -S Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K220520 Device Name PM Excellence SEQUR 100 Surgical Face Mask Indications for Use (Describe) The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials. | Type of Use (Select one or both, as applicable) | <table><tr><td></td><td>Drug Use, Compounded with FDA-bulk Substance(s)</td></tr><tr><td></td><td>Drug Use, Compounded with FDA-approved Drug(s)</td></tr></table> | | Drug Use, Compounded with FDA-bulk Substance(s) | | Drug Use, Compounded with FDA-approved Drug(s) | |-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|-------------------------------------------------|--|------------------------------------------------| | | Drug Use, Compounded with FDA-bulk Substance(s) | | | | | | | Drug Use, Compounded with FDA-approved Drug(s) | | | | | | | 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}------------------------------------------------ K220520 Page 1 of 6 ### 510[k] Summary ### This Summary of 510(k) pre-market notification was prepared in accordance with the requirements of 21 CFR Part 807.92 Prepared Date: May 28,2022 ### 1. Submitter Identification: Name: PM Excellence, LLC Address: 2864 Wilson Avenue, Bellmore, NY 11710 Official Correspondent: Nina Bektic-Marrero Title: Managing Director E-mail: nina@mypmexcellence.com Telephone: +1(917) 640-7980 ### 2. Regulatory Information: Name of Device: Surgical Mask (single use only) Proprietary Name: PM Excellence SEQUR 100 Surgical Face Mask Panel: General Hospital Regulatory Class: Class II Classification Regulation Name: 21CFR 878.4040. Surgical Apparel Product Code: FXX Classification Name: Mask, Surgical Submission type: Traditional 510(k) ### 3. Primary Predicate Device Information: Primary Predicate Device Manufacturer: Wellmien (Suzhou) Import and Export Trading Co., Ltd. Device: Surgical Face Mask 510(k) No.: K101000 #### Device Description: 4. PM Excellence SEQUR 100 Surgical Face Mask (light blue) for single use only, are pleated 3ply masks that consist of the following materials: hydrophobic nonwoven PP (polypropylene) spunbond 35 gsm, 17.5cm, light blue (outer layer); nonwoven PP (poly propylene) spunbond 30gsm, 19.5cm, white (inner layer); and nonwoven PP (polypropylene) meltblown 30gsm, 17.5cm, white (middle filter layer). The PM Excellence SEQUR 100 Surgical Face Mask Light Blue also utilizes soft, latex-free elastic earloops and malleable wire nose piece. All the materials {4}------------------------------------------------ used in the construction of the PM Excellence SEQUR 100 Surgical Face Mask (light blue) are substantially equivalent to those used in currently marketed devices, including the primary predicate device K101000 ### 5. Intended Use The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate materials. ### 6. Comparison to Primary Predicate Device: PM Excellence SEQUR 100 Surgical Face Mask Light Blue for single use only, is compared with its primary predicate device: K101000, Surgical Face Mask by Wellmien (Suzhou) Import and Export Trading Co.. Ltd. The design, dimensions, material, and performance of both devices are very similar, and the two products are substantially equivalent in safety and effectiveness. The only difference between the primary predicate device and the subject device is that the three layers of Polypropylene materials have very similar but not the same gsm (grams per square meter). It is important however to note that this difference does not raise any concerns regarding the safety and effectiveness of the subject device as evidenced by the test results for biocompatibility and performance. | i. Comparison to the Primary Predicate Device | | | |-----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Description | Subject Device<br>K220520 (PM Excellence<br>SEQUR 100 Surgical Face<br>Mask) | Primary Predicate Device<br>K101000 Wellmien Surgical<br>Mask | | Applicant | PM Excellence, LLC | Wellmien (Suzhou) Import and<br>Export Trading Co., Ltd | | Classification<br>Regulation | 21CFR 878.4040 | 21CRF 878.4040 | | Classification,<br>Product Code | Class II,<br>FXX | Class II,<br>FXX | | Common name | Surgical Face Mask | Surgical Face Mask | | Indication for use | The PM Excellence SEQUR 100 Surgical Face Masks (for single use only) are indicated as protective nose and mouth covering for healthcare workers and patients. These face masks are intended for use in infection control practices as well as any medical or surgical procedure or situations where there is a risk of exposure to microorganism, body fluid, and particulate Materials. | 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 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. | | Model | Earloops, Flat Pleated, 3 layers | Earloops, Flat Pleated, 3 layers | | Material | Outer layer: Nonwoven<br>Spunbond hydrophobic<br>Polypropylene Light Blue 35 gsm $\pm$ 2 gsm<br>Middle layer: Nonwoven Melt-blown polypropylene filter white 30 gsm $\pm$ 2 gsm<br>Inner layer: Nonwoven Spunbond<br>Polypropylene white 30 gsm $\pm$ 2 gsm<br>Nose wire: Polyethylene coated steel wire<br>Earloops: Polyester Elastic Non-Latex | Outer facing layer: Spunbond<br>Polypropylene Light Blue 33 gsm $\pm$ 2 gsm<br>Middle layer: Melt-blown polypropylene filter white 33 gsm $\pm$ 2 gsm<br>Inner facing layer: Spunbond<br>Polypropylene white 25 gsm $\pm$ 2 gsm<br>Nose wire: Polyethylene coated steel wire<br>Ear loops: Polyester | | Color | Light Blue | Blue | | Dimension (Width) | 17.5cm $\pm$ 0.2cm | 17.5cm $\pm$ 0.2cm | | Dimension (Length) | 9.5 $\pm$ 0.2cm | 9.5 $\pm$ 0.2cm | | Earloop Length | 16.0 cm $\pm$ 0.5 cm | 16.0 cm $\pm$ 0.5 cm | | Nose Wire Length | 11.0 cm $\pm$ 0.5 cm | 11.0 cm $\pm$ 0.5 cm | | OTC use | Yes | Yes | | Sterility | Non-sterile | Non-sterile | | Usage | Single use, disposable | Single use, disposable | {5}------------------------------------------------ {6}------------------------------------------------ | i. Comparison of Device Performance | | | |---------------------------------------|---------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | Performance<br>Testing | Subject Device (PM Excellence<br>SEQUR 100 Surgical Face<br>Mask) | Primary Predicate Device<br>(K101000) | | Fluid<br>Resistance<br>Performance | 31 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | | Particle<br>Filtration<br>Efficiency | From 98.98% to 99.06% | 99.8% | | Bacterial<br>Filtration<br>Efficiency | From 99.85% to 99.96% | 99.9% | | Differential<br>Pressure (Delta<br>P) | 5.0 to 5.3 mmH2O/cm² | 3.7-4.0 mmH2O/cm² | | Flammability | Class I | Class I | | Biocompatibility | The subject device is non-cytotoxic, non- sensitizing and non-irritating. | Biocompatible. Under the condition of this study the device is non-cytotoxic, non-sensitizing and non-irritating. | ## ii. Discussion of non-clinical tests performed to determine substantial equivalence The following non-clinical tests were performed to determine substantial equivalence. Tests were conducted following the recommended procedures outlined in the respective {7}------------------------------------------------ consensus standards. Test results met all relevant requirements in the test standards and are comparable to the primary predicate device. - Bacterial filtration efficiency (BFE): ASTM F2101 (1) - Differential Pressure (Delta P) EN 14683:2019 Annex C (2) - Latex particle challenge (PFE): ASTM F2299-03 (3) - Flammability: 16CFR 1610 (4) - Biocompatibility: ISO10993 (5) - Fluid Resistance Synthetic Blood Penetration: Resistant Test: ASTM F1862 (6) More detail comparison of the design, technical, and performance characteristics to the primary predicate device are summarized in Section 11: Executive Summary and Primary Predicate Comparison. - Discussion of Clinical Tests Performed 7. Not applicable #### 8. Conclusions The PM Excellence SEQUR 100 Surgical Face Mask Light Blue for single use only have the same intended use, technological characteristics and performance effectiveness as the primary predicate device K101000. Furthermore, bench testing contained in this submission demonstrates that the technological characteristics do not raise any new questions of safety or effectiveness. PM Excellence SEOUR 100 Surgical Face Mask for single use only are substantially equivalent to the primary predicate device K101000. ### i.Compliance with Recognized Standards PM Excellence, LLC hereby certifies that testinghas beenconducted in accordance with and has met the acceptance criteria specified in the table below, prior to the product being marketed. | Test Method | Description | Acceptance Criteria | |------------------------|--------------------------------------------------------------|-------------------------------| | ASTM F1862 | Resistance to Penetration by Synthetic Blood Level 3 160mmHg | 29 out of 32 pass at 160 mmHg | | EN 14683: 2019 Annex C | Differential Pressure | < 6.0mmH2O/cm² | | ASTM F2299 | Sub-Micron Particulate | ≥ 98% | | BFE | Bacterial Filtration Efficiency | ≥ 98% | | 16 CFR Part 1610 | Flammability | Class I | | ISO 10993 | Cytotoxicity | Pass | | ISO 10993-10 | Maximization Sensitization | Pass | | ISO 10993-23 | Intracutaneous Study | Pass | {8}------------------------------------------------ ### ii.Performance Data 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 | Proposed device | Acceptance criteria | Result | |-----------------------------------------|----------------------------------|----------------------------------|--------| | Fluid Resistance<br>Performance | 31 out of 32 pass at 160<br>mmHg | 29 out of 32 pass at 160<br>mmHg | Pass | | Particulate Filtration<br>Efficiency | From 98.98% to 99.06% | ≥ 98% | Pass | | Bacterial Filtration<br>Efficiency | From 99.85% to 99.96% | ≥ 98% | Pass | | Differential Pressure<br>(Delta-P) Test | 5.0 to 5.3 mmH2O/cm² | < 6.0mmH2O/cm² | Pass | | Flammability Testing | Class 1 | Class 1 | Pass | ### iii.Conclusion The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe and effective, and performs as well as or better than the legally marketed primary predicate device K101000, Surgical Face Mask