Sovereign America Surgical Face Mask

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a solid blue square and the agency name in a lighter blue. The text reads "FDA U.S. FOOD & DRUG ADMINISTRATION". March 19, 2021 Homtex, Inc. Jeremy Wootten President and CFO 2125 2nd Avenue SW Cullman, Alabama 35055 Re: K201095 Trade/Device Name: Sovereign America Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 11, 2021 Received: February 26, 2021 Dear Jeremy Wootten: 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, Ryan Ortega, Ph.D. 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 {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K201095 Device Name Sovereign America Surgical Mask, Model: 2000SM1 Indications for Use (Describe) Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile. 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. 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Preparation Date: March 17, 2021 #### 2. Submitter: Homtex, Inc. 2125 2nd Avenue SW Cullman AL 35055 Phone: 256-734-3937 Fax: 256-734-2043 Contact: Jeremy Wooten, President and CFO Email: jeremy.wootten@homtex.com #### 3. Proposed Device: | Trade Name: | Sovereign America Surgical Mask, Model 2000SM1 | |--------------------|------------------------------------------------| | Common Name: | Surgical Mask | | Regulation Number: | 21 CFR 878.4040 | | Classification: | Class II | | Product Code: | FXX | #### 4. Predicate Device: | 510(k) Number: | K153409 | |--------------------|-----------------------------------------| | Trade Name: | Protect U Guard Earloop Mask and Tie-On | | Common Name: | Surgical Mask | | Regulation Number: | 21 CFR 878.4040 | | Regulatory Class: | Class II | | Product Code: | FXX | {4}------------------------------------------------ #### 5. Device Description: The Sovereign America Surgical Mask is a single use, three-layer, flatpleated surgical mask with ear loops and a nose piece. The device is composed of three layers of nonwoven polypropylene, with the outer layer (Layer 1) and inner layer (Layer 3) being spun-bond nonwoven polypropylene, and the middle layer (Layer 2) being melt-blown nonwoven polypropylene. Layer 1 contains a blue pigment. The device utilizes two elastic ear loops, ultrasonically welded to the mask, to hold the device in place over the users' mouth and nose. The ear loops are polyester spandex elastic, and not made with natural rubber latex. The device also utilizes a malleable nose piece, made of polypropylene coated aluminum wire, to allow the user to fit the device around the bridge of the nose. The mask is provided non-sterile and intended to be a single use, disposable device. #### Intended Use: 6. Sovereign America Surgical Mask is intended for use by healthcare personnel to protect both patients and healthcare personnel against the transfer of microorganisms, bodily fluids and particulate material. This is a single use, disposable device, provided non-sterile. #### Comparison to Predicate Device: 7. | Item | Proposed Device | Predicate Device | Comparison | |----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------| | Manufacturer | Homtex, Inc. | Protect U Guard, LLC | | | Product Code | FXX | FXX | Same | | Classification and<br>Regulation | Class II<br>21 CFR878.4040 | Class II<br>21 CFR878.4040 | Same | | Intend use | The Sovereign American<br>Surgical Mask is intended for<br>use by healthcare personnel to<br>protect both patients and<br>healthcare personnel against<br>the transfer of<br>microorganisms, bodily fluids<br>and particulate material. This<br>is a single use, disposable<br>device, provided non-sterile. | The Protect U Guard Earloop<br>Mask and Tie-On Mask is<br>intended for use by<br>healthcare workers during<br>procedures to protect both<br>patients and healthcare<br>workers against transfer of<br>microorganisms, bodily fluids<br>and airborne particles. This<br>device is single use and<br>provided non-sterile. | Similar | Table 1: General Comparison {5}------------------------------------------------ | Model Style | | Flat-pleated<br>earloops | Flat pleated<br>Earloops or tie-on | Same | |------------------------------------------------------|--------------|---------------------------------------|---------------------------------------|---------| | Material | Outer layer | Spunbond nonwoven<br>polypropylene | Spunbound polypropylene | Same | | | Middle layer | Melt-blown nonwoven<br>polypropylene | Meltblown polypropylene | Same | | | Inner layer | Spunbond nonwoven<br>polypropylene | Spunbound polypropylene | Same | | | Nose Piece | Polypropylene coated<br>aluminum wire | Aluminum strip | Similar | | | Ear loops | Polyester spandex elastic | Urethane elastic fiber | Similar | | Color | | Blue | Blue, White, or Green | Similar | | Dimension (Width) | | 17.5 cm | 17.7 cm | Similar | | Dimension (Length) | | 9.5 cm | 9.5 cm | Same | | OTC use | | Yes | Yes | Same | | Sterility | | Non-Sterile | Non-Sterile | Same | | Use | | Single Use, Disposable | Single Use, Disposable | Same | | Latex | | Not Made with Natural<br>Rubber Latex | Not Made with Natural<br>Rubber Latex | Same | | Performance (ASTM F2100 Level 1) | | | | | | Fluid Resistance<br>(ASTM F1862) | | 29 out of 32 passed at 80 mmHg | 29 out of 32 passed at 80 mmHg | Same | | Bacterial Filtration<br>Efficiency<br>(ASTM F2101) | | 99.1 - 99.8% | 99.17% | Similar | | Particulate Filtration<br>Efficiency<br>(ASTM F2299) | | 99.55 - 99.91 % | 99.18% | Similar | | Differential Pressure<br>(EN 14683/MIL-M-<br>36954C) | | 2.5 - 3.3 mm H2O/cm² | 3.79 mm H2O/cm² | Similar | | Flammability<br>(16 CFR 1610) | | Class 1 | Class 1 | Same | | Biocompatibility | | | | | | Cytotoxicity<br>(MEM Elution)<br>ISO 10993-5:2009 | | Non-Cytotoxic | Non-Cytotoxic | Same | | Intracutaneous<br>Reactivity<br>ISO 10993-10:2010 | | Non-Irritating | Non-Irritating | Same | {6}------------------------------------------------ #### Non-Clinical Testing: 8. Sovereign America Surgical Mask has been tested in conformity with the recognized consensus standards outlined in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submissions issued on March 5, 2004 and in ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks, including performance tests for 1) fluid resistance; 2) bacterial filtration efficiency; 3) particulate filtration efficiency; 4) differential pressure; and 5) flammability as well as biocompatibility tests. The performance testing and biocompatibility testing results showed that Sovereign America Surgical Mask passed all acceptance criteria in the consensus standards as set forth in the Tables 2 and 3 below. ## Table 2: Performance Testing | Testing Standards | Acceptance Criteria<br>ASTM F2100 Level 1 | Sovereign America<br>Surgical Mask<br>(K201095) | Predicate Device<br>(K153409) | |------------------------------------------------------|-------------------------------------------|-------------------------------------------------|-----------------------------------| | Fluid Resistance<br>(ASTM F1862) | 29 out of 32 passed at<br>80 mmHg | 29 out of 32 passed at<br>80 mmHg | 29 out of 32 passed<br>at 80 mmHg | | Bacterial Filtration<br>Efficiency<br>(ASTM F2101) | ≥ 95% | 99.1 - 99.8% | 99.17% | | Particulate Filtration<br>Efficiency<br>(ASTM F2299) | ≥ 95% | 99.55 - 99.91 % | 99.18% | | Differential Pressure<br>(EN 14683/<br>MIL-M-36954C) | < 5.0 mm H2O/cm2 | 2.5 - 3.3 mm H2O/cm2 | 3.79 mm H2O/cm2 | | Flammability (16<br>CFR 1610) | Class 1 | Class 1 | Class 1 | | | Table 3: Biocompatibility Testing | | |--|-----------------------------------|--| | | | | | Testing Items | Standards | Results | |------------------------------------|-------------------|------------------------| | Cytotoxicity (MEM Elution) | ISO 10993-5:2009 | Pass (Non-Cytotoxic) | | Intracutaneous Reactivity | ISO 10993-10:2010 | Pass (Non-Irritating) | | Kligman Maximization Sensitization | ISO 10993-10:2010 | Pass (Non-Sensitizing) | {7}------------------------------------------------ #### 9. Conclusion: The nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate K153409.