(113 days)
The Procedure mask/Surgical mask is 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 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 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 used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile.
The provided text is a 510(k) Summary for a medical device (Procedure mask/Surgical mask/Face mask). It details non-clinical tests conducted to prove substantial equivalence to a predicate device, rather than the development and validation of an AI-powered diagnostic device.
Therefore, I cannot extract information related to:
- Study that proves the device meets acceptance criteria: The document describes non-clinical performance testing of a physical product (face mask) against established standards, not an AI model's performance.
- Sample size used for the test set and data provenance: No test set of patient data, images, or cases is mentioned. The tests are on material properties of the mask.
- Number of experts used to establish ground truth and qualifications: Ground truth for a face mask's performance is established by standardized physical and biological tests, not expert consensus on medical images or patient data.
- Adjudication method for the test set: Not applicable as there's no diagnostic test set requiring adjudication.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable, as this is for evaluating human reader performance with and without AI assistance for interpretation tasks.
- Standalone (algorithm only without human-in-the-loop performance) study: Not applicable, as this is a physical medical device, not an algorithm.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth here refers to the measured physical and biological properties of the mask.
- Sample size for the training set: There is no training set mentioned, as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Instead, I can present the acceptance criteria and reported device performance from the non-clinical tests for the traditional medical device (face mask) as provided in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Result (Proposed Device) |
|---|---|---|---|
| Resistance to Penetration by Synthetic Blood (ASTM F1862/F1862M: 2017) | To evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHg | Level 1: Pass at 80mmHg |
| Level 2: No penetration at 120 mmHg | Level 2: Pass at 120mmHg | ||
| Particulate Filtration Efficiency (PFE) (ASTM F2299/F2299M-03 (2017)) | To determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 96.05% Black mask: Pass at 96.03% |
| Level 2: ≥98% | Blue mask: Pass at 98.78% Black mask: Pass at 98.75% | ||
| Bacterial Filtration Efficiency (BFE) (ASTM F2101: 2019) | To determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥95% | Blue mask: Pass at 98.25% Black mask: Pass at 98.25% |
| Level 2: ≥98% | Blue mask: Pass at 98.72% Black mask: Pass at 98.73% | ||
| Differential Pressure (EN 14683:2019+AC: 2019 Annex C) | To determine the differential pressure of the test article. | Level 1: <5.0 mmH2O/cm² | Blue mask: Pass at 3.5 mmH2O/cm² Black mask: Pass at 3.5 mmH2O/cm² |
| Level 2: <6.0 mmH2O/cm² | Blue mask: Pass at 3.5 mmH2O/cm² Black mask: Pass at 3.6 mmH2O/cm² | ||
| Flammability (16 CFR Part 1610) | To evaluate the flammability of the test article. | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5:2009) | To evaluate the cytotoxicity of the test article. | 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. |
| Sensitization (ISO 10993-10:2010) | To evaluate the sensitization of the test article. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation (ISO 10993-10:2010) | To evaluate the irritation of the test article. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
2. Sample size used for the test set and the data provenance
The document does not specify general "sample sizes" in terms of number of patient cases or images, as this is a physical product's performance validation. The "tests" refer to laboratory evaluations of material properties. The provenance of the testing data is not explicitly stated beyond being "non-clinical tests" conducted to verify compliance with standards. It does not indicate country of origin for test data or whether tests were retrospective or prospective, as these are material property tests, not clinical studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device (a face mask) is established by adherence to recognized international and national standards (e.g., ASTM, EN, ISO, CFR) for material performance, not by expert consensus on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no diagnostic test set requiring human adjudication.
5. 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
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids, not for physical medical devices like face masks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by the results of standardized physical and biological tests, which measure specific material properties and performance characteristics against predefined thresholds in the cited standards (e.g., ASTM F1862/F1862M for synthetic blood penetration, ASTM F2101 for bacterial filtration efficiency, ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This is not an AI/ML device; therefore, there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for an AI model.
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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 and 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.
May 17, 2022
Winner Medical Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd P.O. Box 120-119 Shanghai, 200120 China
Re: K220194
Trade/Device Name: Procedure mask/Surgical mask/Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 9, 2022 Received: April 20, 2022
Dear Ms. 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.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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)
Device Name
Procedure mask/Surgical mask/Face mask
Indications for Use (Describe)
The Procedure mask/Surgical mask is 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 non-sterile.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section
807.92. The assigned 510(k) Number: K220194
-
- Date of Preparation: 01/18/2022
-
- Sponsor Identification
Winner Medical Co., Ltd.
Winner Industrial Park, No.660 Bulong Road, Longhua District, Shenzhen Guangdong, China 518109
Establishment Registration Number: 9616433
Contact Person: Mingni Liu Position: Regulatory Affairs Tel: +86-755-28138888-8822 Email: 2346@winnemedical.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jinlei Tang (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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4. Identification of Proposed Device
Trade Name: Procedure mask/Surgical mask/Face mask Common Name: Surgical Face Mask
Regulatory Information Classification Name: Mask, Surgical; Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040; Review Panel: General Hospital;
Indications for use:
The Procedure mask/Surgical mask/Face mask is 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 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 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 used to secure the mask over the users' mouth and face. The nose clip is made of Iron and polypropylene. Users can adjust the nose piece according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off. The ear loop masks are available in two size, 17.5×9.5 cm and 14.5×9 cm; the tie-on mask is available in one size, 17.5×9.5 cm. And the colors for the ear loop mask are blue and black; the color for the tie-on mask is blue. Both the ear loop and tie-on masks are available in level 1 and level 2 masks based on ASTM F2100-19 due to the difference in gram weight of the mask body. The proposed device is provided in non-sterile. All specifications of the proposed device are provided in table 1.
| Product name | ASTM F2100-19level | Ear strap type | Size (cm) | Color | Layers | Sterilization |
|---|---|---|---|---|---|---|
| Proceduremask/Surgicalmask/Facemask | Level 1 | Ear loop | 17.5x9.5 | Blue | 3 | Non-sterile |
| 17.5x9.5 | Black | |||||
| Ear loop | 14.5x9 | Blue | ||||
| 14.5x9 | Black | |||||
| Tie-on | 17.5x9.5 | Blue |
| Table 1 Procedure mask/Surgical mask Description | ||
|---|---|---|
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| Level 2 | Ear loop | 17.5x9.5 | Blue | ||
|---|---|---|---|---|---|
| Black | |||||
| 14.5x9 | Blue | ||||
| Black | |||||
| Tie-on | 17.5x9.5 | Blue |
న్. Identification of Predicate Device
510(k) Number: K211462 Product Name: Disposable Ear-loop Medical Face Mask Disposable Tie-On Medical Face Mask (Select Level 1 and Level 2 masks as predicate device)
Summary of Non-Clinical Test 6.
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:
-
ASTM F1862/F1862M: 2017 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
-
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 F2101: 2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
-
ASTM F2100: 2019 Standard Specification for Performance of Materials Used in Medical Face Masks
-
EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance toPenetration bySynthetic blood | The test was performed in accordance with ASTMF1862/F1862M: 2017Standard Test Method forResistance of Medical Face | Level 1: No penetrationat 80 mmHg | Level 1: Pass at80mmHg |
| Level 2: No penetrationat 120 mmHg | Level 2: Pass at120mmHg | ||
| Masks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume ata Known Velocity) to evaluatethe effectiveness of the testarticle from possible exposureto blood and other body fluids. | |||
| The test was performed inaccordance with ASTMF2299/F2299M-03 (2017)Standard Test Method forDetermining the InitialEfficiency of Material Used inmedical Face Masks toPenetration by Particulatesusing Latex Spheres todetermine the particlefiltration efficiency (PFE) ofthe test article. | Level 1: ≥95% | Blue mask:Pass at 96.05%Black mask:Pass at 96.03% | |
| ParticulateFiltration Efficiency | Level 2: ≥98% | Blue mask:Pass at 98.78%Black mask:Pass at 98.75% | |
| Bacterial FiltrationEfficiency | The test was performed inaccordance with ASTMF2101: 2019 Standard TestMethod for Evaluating theBacterial Filtration Efficiency(BFE) of Medical Face MaskMaterials, Using a BiologicalAerosol of Staphylococcusaureus to determine thebacterial filtration efficiency(BFE) of the test article. | Level 1: ≥95% | Blue mask:Pass at 98.25%Black mask:Pass at 98.25% |
| Level 2: ≥98% | Blue mask:Pass at 98.72%Black mask:Pass at 98.73% | ||
| DifferentialPressure | The test was performed inaccordance with EN14683:2019+AC: 2019 AnnexC Medical face masks -Requirements and testmethods to determine thedifferential pressure of the testarticle. | Level 1:<5.0 mmH2O/cm² | Blue mask:Pass at 3.5 mmH2O/cm²Black mask:Pass at 3.5 mmH2O/cm² |
| Level 2:<6.0 mmH2O/cm² | Blue mask:Pass at 3.5 mmH2O/cm² | ||
| Black mask:Pass at 3.6 mmH2O/cm2 | |||
| Flammability | The test was performed in accordance with 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles to evaluate the flammability of the test article. | Class 1 | Class 1 |
| Cytotoxicity | The test was performed in accordance with ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity to evaluate the cytotoxicity of the test article. | 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. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the sensitization of the test article. | Non-sensitizing | Under the conditions of the study, the proposed device was non-sensitizing. |
| Irritation | The test was performed in accordance with ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization to evaluate the irritation of the test article. | Non-irritating | Under the conditions of the study, the proposed device was non-irritating. |
Table 2 Comparison of Procedure mask/Surgical mask
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7. Clinical Test Conclusion
No clinical study is included in this submission.
8. Technological Characteristics Comparison
| ITEM | Proposed Device | Predicate DeviceK211462 | Remark | |
|---|---|---|---|---|
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| IndicationsforUse | The Procedure mask/Surgicalmask is intended to be worn toprotect both the patient andhealthcare personnel from transferof microorganisms, body fluids,and particulate material. Theseface masks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | The Disposable Ear-loop Medical FaceMask/Disposable Tie-On Medical FaceMask is intended to be worn to protectboth the patient and healthcare personnelfrom transfer of microorganisms, bodyfluids, and particulate material. Theseface masks are intended for use ininfection control practices to reduce thepotential exposure to blood and bodyfluids. This is a single-use, disposabledevice, provided nonsterile. | Same | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Ear loop / Tie-on | Ear loop / Tie-on | Same | |
| Dimension | Ear loops:Body: 175 mm×95 mm, nose clip:110mm, Ear-loop: 178mmBody: 145 mm×90 mm, nose clip:85mm, Ear-loop: 145mmTie-on:Body: 175 mm×95 mm, nose clip:110mm, Ear-loop: 900mm | Ear loops: Body: 175 mm×95 mm, noseclip: 125mm, Ear-loop: 175mmTie-on: Body: 175 mm×95 mm, noseclip: 125mm, Tie strings: 910mm | Different | |
| ASTMF2100Level | Level 1 | Level 1 | Level 2 | Same |
| FluidResistance | Passat80mmHg | Pass at 80mmHg | Passat120mmHg | Same |
Table 3 Comparison of Procedure mask/Surgical mask
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| Particulatefiltrationefficiency | Blue mask:Pass at 96.05% | Blue mask:Pass at 98.78% | Pass at 98.2% | Pass at 99.3% | Different | ||
|---|---|---|---|---|---|---|---|
| Black mask:Pass at 96.03% | Black mask:Pass at 98.75% | ||||||
| Bacterialfiltrationefficiency | Blue mask:Pass at 98.25% | Blue mask:Pass at 98.72% | Pass at 98.9% | Pass at 99.4% | Different | ||
| Black mask:Pass at 98.25% | Black mask:Pass at 98.73% | ||||||
| Differentialpressure | Blue mask:Pass at 3.5 mmH2O/cm² | Blue mask:Pass at 3.5 mmH2O/cm² | Passed at 3.6mmH2O/cm² | Pass at 4.0mmH2O/cm2 | Different | ||
| Black mask:Pass at 3.5 mmH2O/cm² | Black mask:Pass at 3.6 mmH2O/cm² | ||||||
| Flammability | Class 1 | Class 1 | Same | ||||
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same | ||||
| Materials | |||||||
| Ear loop | Polyester and spandex | Nylon and Spandex | |||||
| Tie strings | 38 /m² polypropylene nonwoven | 35g/ m² PP non-woven cloth | |||||
| Nose clip | Iron and polypropylene | Aluminum wire | |||||
| Maskbody | Outermaterial | 25g/m²polypropylenenonwoven | 30g/m²polypropylenenonwoven | 23g/ m² PP non-woven cloth | Different | ||
| Middlematerial | 25g/m²polypropylenemelt-blownnonwoven | 30g/m²polypropylenemelt-blownnonwoven | 22g/ m² PPnon-wovencloth | 25g/m² PPnon-wovencloth | 33g/m²PPnon-wovencloth | ||
| Innermaterial | 25g/m²polypropylenenonwoven | 30g/m²polypropylenenonwoven | 20g/ m² PP non-woven cloth | ||||
| Colors | Blue; Black | Blue | Different | ||||
| Biocompatibility | |||||||
| Cytotoxicity | Under the conditions of the study, the proposed device was non-cytotoxic. | Under the conditions of the study, the proposed device was non-cytotoxic. | Same | ||||
| Sensitization | Under the conditions of the study, the proposed device was non-sensitizing. | Under the conditions of the study, the proposed device was non-sensitizing. | Same | ||||
| Irritation | Under the conditions of the study, the proposed device was non-irritating. | Under the conditions of the study, the proposed device was non-irritating. | Same |
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510(k) Summary
| non-irritating. | |||
|---|---|---|---|
| Sterilization | |||
| Method | Non-sterile | Non-sterile | Same |
Different - Dimension (mm)
The dimension for the proposed device is different from the predicate device. The mask body of the proposed device is provided in two dimensions: ear loop masks - 17.5×9.5 cm and 14.5×9 cm; tie-on mask - 17.5×9.5 cm. While the predicate device is only provided in one dimension, 17.5×9.5 cm. However, the difference in dimension of mask body does not affect indications for use and will not raise any safety issues. The dimensions of the nose clip, ear loop and ties for the proposed device are different from the predicate device. However, these difference does not affect the protective performance of masks. The nose clip is just to fix the mask on the bridge of the nose and keep it from falling off. And the ear loop and ties are also designed to attach masks to the user's mouth and nose. Thus, this difference will not affect the safety and effectiveness of the proposed device.
Different - Particulate efficiency
The test result for particulate filtration efficiency for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of 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 test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affect the safety and effectiveness of proposed device.
Different - Differential pressure
The test result for differential pressure for the proposed device is different from the predicate device. However, the test result for the proposed device can meet the requirements of level 1 / level 2 mask based on ASTM F2100-19. Thus, this difference will not affectiveness of proposed device.
Different - Materials
The material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.
Different - Colors
The color of proposed device is provided in blue and black, while the predicate device is blue. However,
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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.
- Conclusion 9.
The conclusions drawn from the nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as the legally marketed predicate device K211462.
§ 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.