(220 days)
The single-use medical 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, provided sterile and non-sterile.
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are held in place over the users' mouth and nose by ear loops/ ties welded to the mask. The nose clip is made of polypropylene and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-19, which are provided in following table. The difference of the level 1, level 2 and level 3 masks is the gram weight of the melt-blown nonwoven. The gram weight of the melt-blown nonwoven for level 1 is 30g/m², and that for level 2 and level 3 masks is 40g/m². Level 2 and level 3 masks are exactly the same and are divided into level 2 and level 3 just for marking. The proposed devices are provided in sterile and non-sterile two types.
This document describes the premarket notification (510(k)) for a Single-use Medical Face Mask, not an AI/ML medical device. Therefore, the information requested in points 2-9 of your prompt (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) is not applicable or cannot be extracted from this document, as it pertains to the performance evaluation of the physical medical face mask against established industry standards.
However, I can extract information related to the acceptance criteria and the study proving the device meets these criteria as presented in the document for the physical medical face mask.
Here's the table of acceptance criteria and reported device performance based on the provided text, focusing on the non-clinical tests:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Method | Acceptance Criteria | Reported Device Performance (Test Result) |
|---|---|---|
| Resistance to Penetrationby Synthetic blood (ASTM F1862/F1862M-17) | Level 1: No penetration at 80 mmHg;Level 2: No penetration at 120 mmHg;Level 3: No penetration at 160 mmHg | Sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgSterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgNon-sterile Tie-on: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHgNon-sterile Ear loop: Level 1: Pass at 80 mmHg; Level 2: Pass at 120 mmHg; Level 3: Pass at 160 mmHg |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101-2019) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-on: Level 1: 98.48%; Level 2: 99.84%; Level 3: 99.85%Sterile Ear loop: Level 1: 98.38%; Level 2: 99.86%; Level 3: 99.89%Non-sterile Tie-on: Level 1: 98.39%; Level 2: 99.82%; Level 3: 99.87%Non-sterile Ear loop: Level 1: 98.67%; Level 2: 99.86%; Level 3: 99.88% |
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-on: Level 1: 99.22%; Level 2: 99.85%; Level 3: 99.88%Sterile Ear loop: Level 1: 99.23%; Level 2: 99.86%; Level 3: 99.88%Non-sterile Tie-on: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.88%Non-sterile Ear loop: Level 1: 99.23%; Level 2: 99.87%; Level 3: 99.87% |
| Differential Pressure (EN 14683:2019) | Level 1: <5.0 mm H2O/cm²Level 2: <6.0 mm H2O/cm²Level 3: <6.0 mm H2O/cm² | Sterile Tie-on: Level 1: 4.00 mm H2O/cm²; Level 2: 4.83 mm H2O/cm²; Level 3: 4.90 mm H2O/cm²Sterile Ear loop: Level 1: 3.83 mm H2O/cm²; Level 2: 4.77 mm H2O/cm²; Level 3: 4.90 mm H2O/cm²Non-sterile Tie-on: Level 1: 4.10 mm H2O/cm²; Level 2: 4.90 mm H2O/cm²; Level 3: 4.93 mm H2O/cm²Non-sterile Ear loop: Level 1: 4.00 mm H2O/cm²; Level 2: 4.90 mm H2O/cm²; Level 3: 4.97 mm H2O/cm² |
| Flammability (16 CFR 1610) | Class I | Class I (for all levels) |
| EO ECH Residual Test (ISO 10993-7:2008) | EO residual shall not exceed 4mg/deviceECH residual shall not exceed 9mg/device | EO residual was less than 4mg/deviceECH residual was less than 9mg/device |
| Cytotoxicity (ISO 10993-5: 2009) | The viability should be >70% of the blank.And the 50% extract of the test sample should have at least the same or a higher viability than the 100% extract. | The viability was ≥70% of the blank. And the 50% extract of the test sample had a higher viability than the 100% extract.Under the conditions of the study, the proposed device was non-cytotoxic. |
| Irritation (ISO 10993-10: 2010) | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
| Sensitization (ISO 10993-10: 2010) | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
Study Details (Relevant to medical device testing, not AI/ML performance)
1. Sample sized used for the test set and the data provenance:
- Sample Size: The document specifies that tests for Resistance to Penetration by Synthetic Blood, Bacterial Filtration Efficiency, Particulate Filtration Efficiency, and Differential Pressure were conducted "from 3 non-consecutive lots." This indicates that at least one sample from each of three different manufacturing lots was tested for these parameters. The exact number of samples per lot is not specified.
- Data Provenance: The tests were non-clinical tests conducted by the manufacturer, Jiangxi Hongda Medical Equipment Group Co., Ltd., based in China, for submission to the U.S. FDA. The document does not specify a country of origin for the data (e.g., patient data), as these are material performance tests, not clinical performance tests. The data is retrospective in the sense that it was collected prior to this submission.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not applicable for this type of medical device submission. The "ground truth" for a medical face mask's performance is established by standardized test methods (e.g., ASTM, EN, ISO standards) and material properties, not by expert consensus or interpretations of medical images. The tests measure objective physical and biological properties.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies or studies involving expert interpretation of data (e.g., medical images) where there can be inter-reader variability. For the physical and material performance tests of a face mask, the results are quantitative and objective, based on standardized testing procedures.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- This information is not applicable. This document is for a physical medical device (face mask), not an AI/ML medical device. Therefore, no MRMC comparative effectiveness studies involving human readers and AI assistance were conducted or are relevant to this submission.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This information is not applicable. This is not an AI/ML algorithm-based device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this device is based on objective measurements from standardized non-clinical laboratory tests according to recognized consensus standards (ASTM, EN, ISO). For example, Bacterial Filtration Efficiency has a specific test method that yields a quantitative percentage. There is no subjective interpretation or clinical outcomes data used to establish "ground truth" for these performance characteristics.
7. The sample size for the training set:
- This information is not applicable. Since this is a physical medical device (face mask) and not an AI/ML device, there is no "training set" in the context of machine learning. The device production involves manufacturing processes, and testing is performed on samples from production lots.
8. How the ground truth for the training set was established:
- This information is not applicable for the same reason as point 7.
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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 FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
October 8, 2021
Jiangxi Hongda Medical Equipment Group Co., Ltd. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai. 200120 China
Re: K210622
Trade/Device Name: Single-Use Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 04, 2021 Received: September 14, 2021
Dear Diana Hong:
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
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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 Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K210622
Device Name Single-use Medical Face Mask
Indications for Use (Describe)
The single-use medical 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, provided sterile and non-sterile.
Level 1 mask Models: Sterile Tie-on, Sterile Ear loop, Non-sterile Tie-on, Non-sterile Ear loop Level 2 mask Models: Sterile Tie-on. Sterile Ear loop. Non-sterile Tie-on. Non-sterile Ear loop Level 3 mask Models: Sterile Tie-on, Sterile Ear loop, Non-sterile Tie-on, Non-sterile Ear loop
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)
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510(k) Summary K210622
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number: K210622
-
- Date of Preparation: 10/07/2021
-
- Sponsor Identification
Jiangxi Hongda Medical Equipment Group Co., Ltd. 39 South Shengli Road, Jinxian County, Nanchang City, Jiangxi Province, China.
Establishment Registration Number: 3007392007.
Contact Person: Xiaohua Yang Position: Management representative Tel: +86-791-85660368 Fax: +86-791-85660368 Email: jsb@jxhd.cn
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Ying Xu (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: 360-925-3199 Email: info@mid-link.net
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-
- Identification of Proposed Device Trade Name: Single-use Medical Face Mask Common Name: Surgical Mask
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX: Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
- Identification of Proposed Device Trade Name: Single-use Medical Face Mask Common Name: Surgical Mask
Indication for use:
The single-use medical 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, provided sterile and non-sterile.
Device Description:
The proposed device is a three-layer, single-use, flat- pleated mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the middle layer is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and tie-on. The ear loops are made of polyester and spandex, and the ties are made of polypropylene nonwoven. The ear loops/ties are held in place over the users' mouth and nose by ear loops/ ties welded to the mask. The nose clip is made of polypropylene and iron. Users can adjust the nose clip according to the shape of the bridge of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. Both the ear loop and tie-on masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-19, which are provided in following table. The difference of the level 1, level 2 and level 3 masks is the gram weight of the melt-blown nonwoven. The gram weight of the melt-blown nonwoven for level 1 is 30g/m², and that for level 2 and level 3 masks is 40g/m². Level 2 and level 3 masks are exactly the same and are divided into level 2 and level 3 just for marking. The proposed devices are provided in sterile and non-sterile two types.
| ASTM | Specification | Ear loop | Tie-on | Color | Sterility |
|---|---|---|---|---|---|
| F2100-19 | √ | Sterile | |||
| Level 1 | $17.5 \times 9.5$ cm | √ | White | Sterile | |
| √ | White | Non-sterile | |||
| √ | White | Sterile | |||
| √ | White | Non-sterile |
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| Level 2 | √ | White | Sterile | ||
|---|---|---|---|---|---|
| √ | White | Non-sterile | |||
| √ | White | Sterile | |||
| √ | White | Non-sterile | |||
| Level 3 | √ | White | Sterile | ||
| √ | White | Non-sterile | |||
| √ | White | Sterile | |||
| √ | White | Non-sterile |
5. Identification of Predicate Device
510(k) Number: K160269 Product Name: Surgical Face Masks (Ear loops and Tie-on)
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- A ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritation and skin sensitization:
-
ISO 10993-5:2009 Biological evaluation of medical device-Part 5: Tests for in vitro cytotoxicity;
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- A ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials;
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
-
ASTM 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);
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
EN 14683: 2019 Medical face masks- Requirements and test methods;
-
ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration:
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals;
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| Models/types | Test Method | Acceptance Criteria | Test Result |
|---|---|---|---|
| Sterile Tie-on | Resistance to Penetrationby Synthetic blood from 3non-consecutive lotsASTM F1862/F1862M-17Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood(Horizontal Projection ofFixed Volume at a KnownVelocity) | Level 1: No penetrationat 80 mmHg;Level 2: No penetrationat 120 mmHg;Level 3: No penetrationat 160 mmHg | Sterile Tie-onLevel 1: Pass at 80 mmHg;Level 2: Pass at 120 mmHg;Level 3: Pass at 160 mmHgSterile Ear loopLevel 1: Pass at 80 mmHg;Level 2: Pass at 120 mmHg;Level 3: Pass at 160 mmHgNon-sterile Tie-onLevel 1: Pass at 80 mmHg;Level 2: Pass at 120 mmHg;Level 3: Pass at 160 mmHgNon-sterile Ear loopLevel 1: Pass at 80 mmHg;Level 2: Pass at 120 mmHg;Level 3: Pass at 160 mmHg |
| Sterile Ear loop | |||
| Non-sterile Tie-on | |||
| Non-sterile Ear loop | |||
| Bacterial FiltrationEfficiency from 3non-consecutive lotsASTM F2101-2019Standard Test Method forEvaluating the BacterialFiltration Efficiency (BFE)of Medical Face MaskMaterials, Using aBiological Aerosol ofStaphylococcus aureus | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-onLevel 1: 98.48%Level 2: 99.84%Level 3: 99.85%Sterile Ear loopLevel 1: 98.38%Level 2: 99.86%Level 3: 99.89%Non-sterile Tie-onLevel 1: 98.39%Level 2: 99.82%Level 3: 99.87%Non-sterile Ear loopLevel 1: 98.67%Level 2: 99.86%Level 3: 99.88% | |
| Particulate FiltrationEfficiency from 3non-consecutive lotsASTM F2299/F2299M-03 | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Sterile Tie-onLevel 1: 99.22%Level 2: 99.85%Level 3: 99.88% | |
| (2017) Standard TestMethod for Determining theInitial Efficiency ofMaterial Used in medicalFace Masks to Penetrationby Particulates using LatexSpheres | Sterile Ear loopLevel 1: 99.23%Level 2: 99.86%Level 3: 99.88%Non-sterile Tie-onLevel 1: 99.23%Level 2: 99.87%Level 3: 99.88%Non-sterile Ear loopLevel 1: 99.23%Level 2: 99.87%Level 3: 99.87% | ||
| Differential Pressure from 3non-consecutive lotsEN 14683:2019 Medicalface masks- Requirementsand test methods | Level 1 <5.0 mm H2O/cm²Level 2: <6.0 mm H2O/cm²Level 3: <6.0 mm H2O/cm² | Sterile Tie-onLevel 1: 4.00 mm H2O/cm²Level 2: 4.83 mm H2O/cm²Level 3: 4.90 mm H2O/cm²Sterile Ear loopLevel 1: 3.83 mm H2O/cm²Level 2: 4.77 mm H2O/cm²Level 3: 4.90 mm H2O/cm²Non-sterile Tie-onLevel 1: 4.10 mm H2O/cm²Level 2: 4.90 mm H2O/cm²Level 3: 4.93 mm H2O/cm²Non-sterile Ear loopLevel 1: 4.00 mm H2O/cm²Level 2: 4.90 mm H2O/cm²Level 3: 4.97 mm H2O/cm² | |
| Flammability from 3non-consecutive lots16 CFR 1610 Standard forthe Flammability ofClothing TextilesCorrections | Class I | Class I | |
| EO ECH Residual TestISO 10993-7:2008 | EO residual shall notexceed 4mg/deviceECH residual shall notexceed 9mg/device | EO residual was less than4mg/deviceECH residual was less than9mg/device | |
| CytotoxicityISO 10993-5: 2009 | The viability should be>70% of the blank | The viability was ≥70% ofthe blank. And the 50% | |
| Biological Evaluation ofMedical Devices-Part 5:Tests for in VitroCytotoxicity | And the 50% extract ofthe test sample shouldhave at least the sameor a higher viabilitythan the 100% extract. | extract of the test samplehad a higher viability thanthe 100% extract.Under the conditions of thestudy, the proposed devicewas non-cytotoxic. | |
| IrritationISO 10993-10: 2010Biological Evaluation ofMedical Devices-Part 10:Tests for Irritation and SkinSensitization | Non-irritating | Under the conditions of thestudy, the proposed devicewas non-irritating. | |
| SensitizationISO 10993-10: 2010Biological Evaluation ofMedical Devices-Part 10:Tests for Irritation and SkinSensitization | Non-sensitizing | Under the conditions of thestudy, the proposed devicewas non-sensitizing. |
Table 1. Summary of the Non-clinical Testing
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-
- Clinical Test Conclusion
No clinical study is included in this submission.
- Clinical Test Conclusion
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-
- Summary of Technological characteristics
| ITEM | Proposed Device K210622 | Predicate Device K160269 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | The single-use medical face masks are intended tobe worn to protect both the patient and healthcarepersonnel from transfer of microorganisms, bodyfluids, and particulate material. These face masksare intended for use in infection control practicesto reduce the potential exposure to blood andbody fluids. This is a single-use, disposabledevice, provided sterile and non-sterile. | The surgical face masks areintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulatematerial. These face masks areintended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids.This is a single-use, disposabledevice, provided non-sterile. | Similar |
| Mask style | Flat-pleated | Flat-pleated | Same |
| Design feature | Ear loop or tie-on | Ear loop or tie-on | Same |
| Color | White | Blue, White | Different |
| Dimension | Mask body: 175×95mmNose Clip: 80 | 175×90mm180×90mm | Different |
| ASTMF2100Level | Level 1, Level 2, Level 3 | Level 1, Level 2, Level 3 | Same |
| Sterility | Non sterile/SterileSterilization method: Ethylene Oxide (EO)Packaging material: Paper and Polyethylene film | Non-sterile | Different |
| EO ECH Residual | EO residue: <4mg/deviceECH residue: <9mg/device | The predicate device is non-sterile | |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Fluid resistance | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | Same |
| Particulatefiltrationefficiency | Level 1:Ear loop (Non-sterile): ≥95%Ear loop (Sterile): ≥95%Tie-on (Non-sterile): ≥95% | Level 1: Pass at 99.6%Level 2: Pass at 99.6%Level 3: Pass at 99.7% | Different |
| Tie-on (Sterile): ≥95% | |||
| Level 2: | |||
| Ear loop (Non-sterile): ≥98% | |||
| Ear loop (Sterile): ≥98% | |||
| Tie-on (Non-sterile): ≥98% | |||
| Tie-on (Sterile): ≥98% | |||
| Level 3: | |||
| Ear loop (Non-sterile): ≥98% | |||
| Ear loop (Sterile): ≥98% | |||
| Tie-on (Non-sterile): ≥98% | |||
| Tie-on (Sterile): ≥98% | |||
| Level 1: | |||
| Ear loop (Non-sterile): ≥95% | |||
| Ear loop (Sterile): ≥95% | |||
| Tie-on (Non-sterile): ≥95% | |||
| Tie-on (Sterile): ≥95% | |||
| Level 2: | |||
| Ear loop (Non-sterile): ≥98% | Level 1: Pass at 98% | ||
| Bacterial filtrationefficiency | Ear loop (Sterile): ≥98% | Level 2: Pass at 98% | Different |
| Tie-on (Non-sterile): ≥98% | Level 3: Pass at 99% | ||
| Tie-on (Sterile): ≥98% | |||
| Level 3: | |||
| Ear loop (Non-sterile): ≥98% | |||
| Ear loop (Sterile): ≥98% | |||
| Tie-on (Non-sterile): ≥98% | |||
| Tie-on (Sterile): ≥98% | |||
| Level 1: | |||
| Ear loop (Non-sterile): <5mmH2O/cm2 | |||
| Ear loop (Sterile): <5mmH2O/cm2 | Level 1: Pass at 2.0 mmH2O/cm2Level 2: Pass at 1.6 mmH2O/cm2Level 3: Pass at 2.5 mmH2O/cm2 | ||
| Tie-on (Non-sterile): <5mmH2O/cm2 | |||
| Differentialpressure | Tie-on (Sterile): <5mmH2O/cm2 | ||
| Level 2: | |||
| Ear loop (Non-sterile): <6mmH2O/cm2 | Different | ||
| Ear loop (Sterile): <6mmH2O/cm2 | |||
| Tie-on (Non-sterile): <6mmH2O/cm2 | |||
| Tie-on (Sterile): <6mmH2O/cm2 | |||
| Level 3: | |||
| Ear loop (Non-sterile): <6mmH2O/cm2 | |||
| Ear loop (Sterile): <6mmH2O/cm2 | |||
| Tie-on (Non-sterile): <6mmH2O/cm2 | |||
| Tie-on (Sterile): <6mmH2O/cm² | |||
| Flammability | Level 1: Class 1 | Level 1: Class 1 | Same |
| Level 2: Class 1 | Level 2: Class 1 | ||
| Level 3: Class 1 | Level 3: Class 1 | ||
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Shelf Life | 3 years | Unknown | Different |
| Patient Contacting Material | |||
| Outer facing layer | Polypropylene Spunbonded Nonwoven | Polypropylene | |
| Middle layer | Polypropylene Melt-blown Nonwoven | 1. Polypropylene spunbond | |
| 2. Polypropylene meltblown | |||
| Inner facing layer | Polypropylene Spunbonded Nonwoven | Polypropylene | Different |
| Nose Clip | Polypropylene and iron | Polyethylene coated steel wire | Different |
| Ear loops/Ties | Ear loops: Polyester and spandexTies: Polypropylene Spunbonded Nonwoven | Ear loops: Polyester, polyurethane | |
| Ties: Polypropylene spunbond or | |||
| polyester spunbond | |||
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the proposeddevice was non-cytotoxic. | Under the conditions of the study, | |
| the subject device was | |||
| non-cytotoxic. | |||
| Sensitization | Under the conditions of the study, the proposeddevice was non-sensitizing. | Under the conditions of the study, | Same |
| the subject device was | |||
| non-sensitizing. | |||
| Irritation | Under the conditions of the study, the proposeddevice was non-irritating. | Under the conditions of the study, | |
| the subject device was | |||
| non-irritating. |
Table 2. Comparison of Technology Characteristics
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Similar – Indication for Use
The indication for use of the proposed device is the same as that of the predicate device, although the proposed device is provided in both sterilized and non-sterilized types. In addition, the performance test and biocompatibility test were also conducted on the sterile masks and the test results demonstrated that the devices can meet the requirements of ASTM F2100-19 and do not raise any adverse effects. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Color
The proposed device is white and the predicate device is provided in two colors, including white mask. And the biocompatibility test has been conducted and test results did not show any adverse effects. Thus, this difference will not affect the safety and effectiveness of the proposed device.
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Different - Dimension
The dimension for the proposed device is different from predicate device. The specification of the proposed device is the common specification of the mask. And, this difference does not affect intended use and will not raise any safety issues. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different —Sterility
The final product status of the proposed device is different from predicate device. The predicate device is non-sterilized, while the proposed device is provided in two states, sterile and non-sterile. Sterilization will affect the safety and effective of the mask. The performance testing of the proposed device has been conducted on the final product and the results show that the proposed device meets the requirements of ASTM F2100-19. For sterile masks, the EO residue testing has been conducted on the final sterile product per ISO 10993-7: 2008 and the results show that the proposed sterile device meets the requirement of EO residue less than 4mg/device and ECH residue less than 9mg/device. Thus, although there are differences between the proposed device and predicate device, the differences will not affect the safety and effectiveness of the proposed device.
Different -Particulate filtration efficiency
The test result for particulate filtration efficiency for the proposed device is different from the predicate device. However, the PFE test result for the proposed device meets the requirements of ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the proposed device is different from the predicate device. However, the BFE test result for the proposed device meets the requirements of ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Differential pressure
The test result for different pressure for the proposed device is different from the predicate device. However, the different pressure test result for the proposed device meets the requirements of ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Shelf Life
Shelf life will affect the safety and effectiveness of mask. However, the performance testing of the proposed device after three years of accelerated aging has been conducted and the test results show that
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the proposed device after three years of aging meets the requirements of ASTM F2100-2019. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Patient Contacting Material
The patient contact material for the propose device is different from predicate device. However, biocompatibility test has been conducted on the propose device and the test result does not show any adverse effect. Thus, this difference will not affect the safety and effectiveness of the proposed device.
-
- Conclusion
The proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K160269.
- Conclusion
§ 878.4040 Surgical apparel.
(a)
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.(b)
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.