Who is the manufacturer of Puravita Medical Fold Flat Surgical Mask?

Puravita M, LLC filed the 510(k) submission for Puravita Medical Fold Flat Surgical Mask (K212740).

What is the FDA product code for Puravita Medical Fold Flat Surgical Mask?

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

What is the regulatory pathway for Puravita Medical Fold Flat Surgical Mask?

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

What are the predicate devices for Puravita Medical Fold Flat Surgical Mask?

Medical Protective Mask (K202107).

Who can help prepare an FDA 510(k) submission like Puravita Medical Fold Flat Surgical Mask?

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.

Puravita Medical Fold Flat Surgical Mask

K212740 · Puravita M, LLC · FXX · Dec 2, 2021 · General, Plastic Surgery

Device Facts

Record ID	K212740
Device Name	Puravita Medical Fold Flat Surgical Mask
Applicant	Puravita M, LLC
Product Code	FXX · General, Plastic Surgery
Decision Date	Dec 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device that is provided non-sterile.

Device Story

4-layer, two-panel fold-flat surgical mask; protects patients and healthcare personnel from microorganisms, body fluids, and particulates. Composed of polypropylene spunbond outer/inner layers and two polypropylene meltblown filter layers; includes nylon/spandex earloops and malleable metal-core nosepiece. Used in clinical settings for infection control; operated by healthcare personnel or general public (OTC). Provides physical barrier against blood/body fluids; reduces potential exposure to contaminants. Non-sterile, single-use, disposable.

Clinical Evidence

No clinical or animal testing performed. Bench testing only. Performance validated via ASTM F2101 (BFE >99.1%), ASTM F2299 (PFE >98%), ASTM F1862 (synthetic blood penetration at 160 mmHg), and EN 14683 (differential pressure <6.0 mmH2O/cm2). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and intracutaneous reactivity).

Technological Characteristics

4-layer fold-flat mask; materials: polypropylene spunbond (inner/outer), polypropylene meltblown (filter layers). Features: nylon/spandex earloops, metal-core nosepiece. Dimensions: 16.3cm x 10.6cm. Non-sterile, single-use. Performance: ASTM Level 3 barrier. No electronic components or software.

Indications for Use

Indicated for patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material during infection control practices. Single-use, disposable, non-sterile device.

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

Medical Protective Mask (K202107)

Related Devices

K211762 — Altor Safety 4-Ply Surgical Mask (Model:62232) · Altor Safety, LLC · Sep 3, 2021
K201625 — Disposable Medical Surgical Mask · Tianjin Saiyuan Technology Co., Ltd. · Jan 12, 2021
K210042 — Disposable Surgical Mask · Suzhou Letian Protective Products Co., Ltd. · Nov 17, 2021
K202548 — Surgical Face Mask · Wanxinda (Guangzhou) Technology Product Co., Ltd. · Mar 10, 2021
K210524 — Surgical Mask · Changzhou Holymed Products Co., Ltd. · Jul 7, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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. December 2, 2021 Puravita M, LLC % Rhonda Alexander Sr. Consultant, Regulatory Strategy IUVO Consulting, LLC P.O. Box 56436 Virginia Beach, Virginia 23456 Re: K212740 Trade/Device Name: Puravita Medical Fold Flat Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: August 30, 2021 Dear Rhonda Alexander: 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, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) #### K212740 Device Name Puravita Medical Fold Flat Surgical Mask #### Indications for Use (Describe) The Puravita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The Puravita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a singleuse, disposable device that is provided non-sterile. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:flex; align-items:center;"><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |--------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><input checked="" type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | |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 # K212740 This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. Date of Summary: November 24, 2021 #### Contact Information | Submitter: | Submitter Contact: | |------------------|------------------------| | PuraVita M, LLC | Jefferson Nemelka | | 1287 W 300 S | Plant Manager | | Lindon, UT 84042 | 801-836-7940 | | | jefferson@puravita.com | | Consultant: | Dr. Rhonda Alexander | |-------------|-------------------------------------| | | Sr. Consultant, Regulatory Strategy | | | IUVO Consulting, LLC | | | (757) 582-4337 | | | ralexander@iuvoconsulting.com | #### Device Information | Trade Name: | PuraVita Medical Fold Flat Surgical Mask | |----------------------|------------------------------------------| | Common Name: | Surgical Face Mask | | Classification Name: | Mask, Surgical | | Classification: | Class II per 21 CFR 878.4040 | | Review Panel: | General Hospital | | Product Code: | FXX | ### Predicate Device: | Manufacturer: | Guangdong Kingfa Sci. & Tech. Co., Ltd, | |----------------|-----------------------------------------| | Product: | Medical Protective Mask | | 510(k) Number: | K202107 | #### Intended Use Statement: The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device that is provided non-sterile. {4}------------------------------------------------ ### Device Description: The PuraVita Medical Fold Flat Surgical Mask is a 4-layer, two panel fold-flat surgical mask. It is comprised of polypropylene spunbond inner and outer layers and two inner polypropylene meltblown filter layers. The mask is white with an extended chamber. The dimensions of each mask are length 16.3cm ± 0.5cm and width 10.6cm ± 0.5cm. The mask has nylon/spandex earloops (length 19.5cm ± 1cm) and a malleable, metal-core nosepiece (0.4cm x 8.2cm x 0.1cm) to provide a functional fit over the nose and mouth of the user. It is a non-sterile, single use, disposable device. This device is not made with natural rubber latex. | Device | Predicate Device: K202107 Guangdong Kingfa Sci. & Tech. Co., LTD, Medical Face Mask, Model KF-A F02(N) | Subject Device: K212740 PuraVita Medical Fold Flat Surgical Mask | Comparison | |---------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Intended Use/Indications for Use | The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask is 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 | The PuraVita Medical Fold Flat Surgical Mask is intended to be worn to protect both patients and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The PuraVita Medical Fold Flat Surgical Mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device that is provided non-sterile. | Similar | | Materials | | | | | Outer Layer | Polypropylene spunbond | Polypropylene spunbond | Same | | Middle Filter Layer #1 | Polypropylene Meltblown | Polypropylene Meltblown | Same | | Middle Filter Layer #2 | Non-woven Polypropylene | Polypropylene Meltblown | Different. Although the 2nd filter layer of the subject device is different than the predicate device, the device met all standards when tested. | | Inner Layer | Polypropylene spunbond | Polypropylene spunbond | Same | | Ear Loops | Spandex and Polyester | Spandex and Nylon | Different. Although the material used in the subject device is slightly different than the predicate device, it passed all biocompatibility test requirements. | | Nose Piece | Iron core polypropylene strip | Dual Iron core polypropylene strip | Similar | | Latex | Not made with natural rubber latex | Not made with natural rubber latex | Same | | Description | | | | | Color | White | White | Same | | Style | Extended chamber flat-folded | Fold Flat | Similar | | Single Use | Yes | Yes | Same | | Sterility | Non-Sterile | Non-sterile | Same | | Length | $16.2cm ± 0.5cm$ | $16.3cm ± 0.5cm$ | Different. Although the specifications and dimensions of the subject device are slightly different than the predicate device. | | | | | the predicate device, the differences are minimal. | | Width | $10.2cm \pm 0.5cm$ | $10.6cm \pm 0.5cm$ | Different. Although the specifications and dimensions of the subject device are slightly different than the predicate device, the differences are minimal. | | Performance Testing | | | | | ASTM Performance Level | ASTM Level 2 | ASTM Level 3 | Different. Although the performance of the subject device differs from that of the predicate device, the subject device performs at least as well as the predicate. | | Fluid/Blood Penetration F1862 | Pass at 120 mmHg | Pass at 160mmHg | Different, however the subject device filters as well as the predicate device. | | Particulate Filtration F2299 | 99.1%, filtration efficiency | >99.4% filtration efficiency | Different; however, the subject and predicate devices both pass the test at ≥98% filtration efficiency. | | Bacterial Filtration F2101 | 99.9% | >99.9% | Same | | Diff. Pressure (Delta-P) MIL-M-36954C | On average of 5.04 mmH2O/cm2 | On average 5.3 mmH2O/cm2 | Different, both the subject device and predicate device pass the test with a differential pressure <6.0mmH2O/cm2. | | Flammability 16 CFR 1610 | Class 1 | Class 1 | Same | | Biocompatibility Testing | | | | | Cytotoxicity | Non-Cytotoxic | Non-Cytotoxic | Same | | Skin Irritation | Non-Irritating | Non-Irritating | Same | | Skin Sensitization | Non-Sensitizing | Non-Sensitizing | Same | ### Comparison to predicate device: {5}------------------------------------------------ - Middle Layer #2 the subject device is constructed using meltblown polypropylene, . while the predicate device is constructed with non-woven polypropylene. The mask meets the same testing requirements as the subject device. - Ear Loops the subject device's ear loops are constructed with spandex and nylon, while ● the predicate device's loops are made with spandex and polyester. Despite this difference in material composition, the ear loops of the subject device meet all biocompatibility requirements; the difference does not negatively affect performance of the device. - The dimensions (length and width) of the subject and predicate devices differ by 0.1cm. . This is within normal limits of variation (± 0.5cm). {6}------------------------------------------------ - . Performance Testing (Fluid/Synthetic Blood Penetration ASTM F1862) – the subject and predicate devices differ in performance of fluid penetration testing. The subject device resists penetration by blood at the same level as the predicate device. - Performance Testing (Particulate Filtration Efficiency ASTM F2299) the subject . performed differently from the predicate device; however, subject and predicate devices both passed the test at ≥ 98% filtration efficiency, meeting the requirements for levels 2 and 3. - Performance Testing (Differential Pressure EN 14683:2019) While the average . differential pressures differ between the subject and predicate devices, both have average differential pressure values that pass the test at <6.0mmH2O/cm2. - There were no differences between the biocompatibility of the subject and predicate . devices. | Test | Device Description/ Sample Size | Test Method/Applicable Standards | Acceptance Criteria | Unexpected Results/ Significant Deviations | Results | Test | Predicate | Subject | Comparison | |-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------|----------------------------------------------------------------------------------------------------------------| | Bacterial Filtration Efficiency ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus FDA Recognition Number: 6-427 Objective of the test: Evaluate the bacteria filtration efficiency (BFE) of face masks samples, using a biological aerosol of Staphylococcus aureus. | Test articles used in the test 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples) were tested; final finished devices | Test methods and procedures (including any specific test conditions) ASTM F2101-19 method was followed under standard conditions with no deviations | Study endpoint, i.e., the specific parameter measured Bacterial filtration efficiency Pre-defined acceptance or pass/fail criteria. Level 2 Barrier: ≥ 98% filtration efficiency Level 3 Barrier: ≥ 98% filtration efficiency | None | All samples tested at least 98% filtration efficiency. All 96 samples meet the "pass" criteria of the test for levels 2 and 3. Comparative testing of the predicate device was not performed, since information regarding its performance can be obtained from FDA's public database. The predicate device passed at 99.9% filtration efficiency. When compared to the information in the public summary, the subject device and predicate device are Similar. | Bacterial Filtration Efficiency | $> 99.1% FiltrationEfficiencyPass$ | $\ge 98% FiltrationEfficiencyPass$ | Similar, both the subject device and predicate device passed the test at the same level ( $\ge$ 98%). | | Differential Pressure (Delta- P) | Test articles used in the test | Test methods and procedures (including any | Study endpoint, i.e., the specific parameter | None | All 96 samples measured an average differential | Differential Pressure (Delta-P) | $< 6.0 mmH_2O/cm^2$ Pass | $< 6.0 mmH_2O/cm^2$ Pass | Same | | EN 14683:2019 + AC 2019 (E) Annex C: Medical Face Masks - Requirements and Test Methods; Method for determination of breathability Objective of the Test: Determine the breathability of masks by measuring the differential air pressure on either side of the test article using a manometer, at a constant flow rate of 8 L/min. | 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples) were tested; final finished devices | specific test conditions) EN 14683:2019 + AC 2019 (E) Annex C method was followed under standard conditions with no deviations | Pressure in mmH2O/cm2 Pre-defined acceptance or pass/fail criteria. Passing differential pressure must be < 6.0mmH2O/cm2. | | (The average pressure was 5.3mmH2O/cm2.) Comparative testing of the predicate device was not performed, since information regarding its performance can be obtained from FDA's public database. The predicate device had an average differential pressure of 5.04mmH2O/cm2. When compared to the information in the public summary, the subject device and predicate device were found to be Similar. | Sub-Micron Particulate Filtration Efficiency at 0.1um of Polystyrene Latex Spheres | 99.9% filtration efficiency Pass | $\ge$ 98% filtration efficiency Pass | Similar; both the subject device and predicate device passed the test at the same level ( $\ge$ 98%). | | Sub-Micron Particulate Filtration Efficiency at 0.1um of Polystyrene Latex Spheres ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks (Parent Standard of ASTM F2299/F2299M-03 (Reapproved 2017) - Test Method for Determining the Initial Efficiency of Materials used in Medical Face Masks to Penetration by Particulates Using Latex Spheres) Objective of Test: Determine the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres | Test articles used in the test 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples) were tested; final finished devices | Test methods and procedures (including any specific test conditions) ASTM F2299/F2299M-03 (reapproved 2017) method was followed under standard conditions with no deviations | Study endpoint, i.e., the specific parameter measured Sub-micron particulate filtration at 0.1 micron Pre-defined acceptance or pass/fail criteria. Level 1 Barrier: ≥ 95% filtration efficiency Level 2 Barrier: ≥ 98% filtration efficiency Level 3 Barrier: ≥ 98% filtration efficiency | None | All samples filtered at a level ≥ 98% filtration efficiency All samples meet the standard's requirements for Level 2 filtration and met the same criteria as the predicate. Comparative testing of the predicate device was not performed, since information regarding its performance can be obtained from FDA's public database. The predicate device's particulate filtration efficiency was 99.1%. When compared to the information in the public summary, the subject device and predicate device were found to be Similar, as they meet the requirements of the same level of filtration efficiency. | Resistance to Penetration by Synthetic Blood | Fluid resistant claimed at 120mmHg Pass | Fluid resistance at 160mmHg Pass | Similar- the subject device resisted blood penetration at least as well as the predicate device. | | Flammability 16 CFR 1610 Standard for the flammability of clothing textiles. 73 FR 62187, Oct. 20, 2008 Objective of the Test: Evaluate the flammability of face mask samples, prohibiting the use of any dangerous flammable materials | Test articles used in the test 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples) were tested; final finished devices | Test methods and procedures (including any specific test conditions) The method described in 16 CFR 1610 was followed under standard conditions with no deviations | Study endpoint, i.e., the specific parameter measured Textile's burn time (the time elapsed from ignition until the stop thread is severed as measured by the timing mechanism of the test apparatus.) Pre-defined acceptance or pass/fail criteria. Class I criteria: The sample does not ignite (DNI) or ignites but extinguishes (IBE). Or burn time, as defined by the standard is ≥ 3.5 seconds | None | All samples either did not ignite (DNI) or ignited but extinguished (IBE). All samples met the requirements for Class I Flammability. Comparative testing of the predicate device was not performed, since information regarding its performance can be obtained from FDA's public database. The predicate device met the requirements for Class I flammability. When compared to the information in the public summary, the subject device and predicate device were found to be Similar. | Flammability | Class 1 | Class 1 | Same | | Resistance to Penetration by Synthetic Blood F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) FDA Recognition Number: 6-406 Objective of the Test: Measure the resistance of medical face masks samples to penetration by synthetic blood. | Test articles used in the test 32 samples of PuraVita Medical Fold Flat Surgical Masks from 3 non-sequential lots (total of 96 samples) were tested; final finished devices | Test methods and procedures (including any specific test conditions) The method described in F1862/F1862M-17 was followed under standard conditions with no deviations | Study endpoint, i.e., the specific parameter measured Visual detection of synthetic blood penetration. Pre-defined acceptance or pass/fail criteria. Pass criteria: No visual blood penetration | None | None of the tested samples showed penetration of synthetic blood up to 160mmHg. All samples passed the requirements of the test and performed as well as the predicate. Comparative testing of the predicate device was not performed, since information regarding its blood penetration performance can be obtained from FDA's public database. The predicate device resisted penetration at 120mmHg. When compared to the information in the public summary, the subject device and predicate device were found to be Similar. | | | | | ### Summary of Bench Performance Testing {7}------------------------------------------------ ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {8}------------------------------------------------ ## Comparison of Performance Testing When compared to FDA's public information regarding the predicate's performance, the subject device was found to perform similarly to or exactly the same as the predicate. {9}------------------------------------------------ {10}------------------------------------------------ ## Summary of Biocompatibility Testing The nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is limited (≤24h). The following tests were conducted on the final, finished form of the subject device to demonstrate that the subject device is biocompatible and safe for its intended use: | Test | Device Description/ Sample Size | Test Method/Applicable Standards | Acceptance Criteria | Unexpected Results/ Significant Deviations | Results | |---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Cytotoxicity - MEM Elution Test FDA Recognition Number: 2-245 Objective of the test: The purpose of this test was to evaluate the cytotoxic potential of extracts of polymeric materials or any other materials intended to be implanted in the human body or that may come into contact with bodily fluids or injectable solutions. | Test articles used in the test 1 Puravita Medical Fold Flat Surgical Mask; final finished device; all components tested together as composite. (Lot No. 12142020A) | Test methods and procedures (including any specific test conditions) The testing standard ANSI/AAMI/ISO 10993-5:2009 was followed under standard conditions with no deviations or amendments. | Study endpoint, i.e., the specific parameter measured The morphology of cells was observed at the 24 and 48 hour examination points according to the criteria stated in the ISO 10993-5 guidelines. The average score for the three test wells and controls at the 48-hour point was used to determine the cytotoxic response. Pre-defined acceptance or pass/fail criteria. Cell morphology graded greater than 2 is considered to have a cytotoxic effect. | None | Pass. Based on qualitative evaluation of the cells exposed to the test article extract, the test article was not considered to have a cytotoxic effect. Comparative testing of the predicate device was not performed, since information regarding its biocompatibility can be obtained from FDA's public database. When compared to the information in the public summary, the subject device and predicate device were both found to be non- cytotoxic. | | Sensitization - Maximization Test for Delayed- Type Hypersensitivity in Hartley Guinea Pigs (ISO 10993- 10:2010) FDA Recognition Number: 2-174 Objective of the test: The purpose of this test was to determine to what extent the test article has the potential to act as a contact sensitizer in guinea pigs. | Test articles used in the test 6 Puravita Medical Fold Flat Surgical Masks; final finished devices; all components tested together as composite. (Lot no. 12142020A) | Test methods and procedures (including any specific test conditions) The study was performed according to ISO 10993-10 guidelines, with no deviations or amendments. | Study endpoint, i.e., the specific parameter measured In the final analysis of data, consideration was given to the overall patterns, intensity, duration, and the nature of reactions of the test as compared with the control. Pre-defined acceptance or pass/fail criteria. Any skin reaction scores received by the test group, which were greater than the scores received by the negative control group, were considered to represent sensitization. | None | Pass. No sensitization reactions or patterns were noted in animals exposed to test article extracted in either saline or cottonseed oil. The test animals did not receive scores higher than those of the negative control animals. Comparative testing of the predicate device was not performed, since information regarding its biocompatibility can be obtained from FDA's public database. When compared to the information in the public summary, the subject device and predicate device were both found to be non- sensitizing. | | Intracutaneous (Intradermal) Reactivity Test ISO 10993- 10:2010 Intracutaneous (Intradermal) Reactivity Test in New Zealand White Rabbits FDA Recognition Number: 2-174 Objective of the test: The purpose of this test was to evaluate local responses to extracts of the test article following intracutaneous injections into rabbits. | Test articles used in the test 2 Puravita Medical Fold Flat Surgical Masks final, finished devices; all components tested together as composite. (Lot No 12142020A) | Test methods and procedures (including any specific test conditions) The study was performed according to ISO 10993-10 guidelines, with no deviations or amendments. | Study endpoint, i.e., the specific parameter measured Injection sites were observed for erythema, eschar formation, edema, and necrosis, and scored at $24 \pm 2$ hours, $48 \pm 2$ hours, and $72 \pm 2$ hours. The average scores for the test sites were calculated and compared to the average scores for the control sites. Pre-defined acceptance or pass/fail criteria. According to ISO 10993-10, the requirements of the test are met if the difference between the test article extract average score and the control average score is 1.0 or less and the test does not fail at any observation period. | Pass. Based on erythema and edema scores, the test article extracted in saline or cottonseed oil did not elicit biologically significant irritation reactions when compared to the control after being injected intracutaneously. Both the subject and predicate devices were found to be non-irritating. Comparative testing of the predicate device was not performed, since information regarding its biocompatibility can be obtained from FDA's public database. When compared to the information in the public summary, the subject device and predicate device were both found to be non- irritating. | | {11}------------------------------------------------ ## Comparison of Biocompatibility Results Between the Subject & Predicate Devices | | Predicate Device (K202107) | Subject Device PuraVita Medical Fold Flat Surgical Mask | Comparison | |----------------------------------------------------|------------------------------------|------------------------------------------------------------------|------------| | Cytotoxicity | Not Cytotoxic | Not Cytotoxic | Sam…

Puravita Medical Fold Flat Surgical Mask

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Puravita Medical Fold Flat Surgical Mask

Device Facts

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Device Story

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Predicate Devices

Related Devices

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