(156 days)
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.
The subject 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 subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. 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. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile.
The provided document is a 510(k) Clearance Letter for a medical device: Procedure mask/Surgical mask/Face mask. This type of document, specifically the "Summary of Non-Clinical Test" section, details the performance characteristics required for the device to meet regulatory standards.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Important Note: The provided document is for a medical mask, not an AI-powered diagnostic device. Therefore, many of the typical questions regarding AI/software performance studies (e.g., sample size for test set, number of experts, adjudication, MRMC studies, training set details, ground truth for AI) are not applicable to this submission. The "study" here refers to physical and biological performance testing of the mask material itself.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are based on established standards like ASTM F2100-23, ASTM F1862/F1862M-24, ASTM F2101-23, EN 14683:2019+AC:2019, 16 CFR Part 1610, and ISO 10993 series. The table below summarizes these criteria and the reported performance:
Table 1: Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (Result) |
|---|---|---|---|
| Resistance to Penetration by Synthetic blood (ASTM F1862/F1862M-24) | To evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | Yellow mask (Level 1): Pass at 80 mmHgWhite mask (Level 1): Pass at 80 mmHgBlue mask: Level 1: Pass at 80 mmHg, Level 2: Pass at 120 mmHg, Level 3: Pass at 160 mmHg |
| Particulate Filtration Efficiency (ASTM F3502-24) | To determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥ 80%Level 2: ≥ 85%Level 3: ≥ 85% | Yellow mask (Level 1): greater than 80% efficiencyWhite mask (Level 1): greater than 80% efficiencyBlue mask (Level 1): greater than 80% efficiencyBlue mask (Level 2): greater than 85% efficiencyBlue mask (Level 3): greater than 85% efficiency |
| Bacterial Filtration Efficiency (ASTM F2101-23) | To determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥ 95%Level 2: ≥ 98%Level 3: ≥ 98% | Yellow mask (Level 1): greater than 95% efficiencyWhite mask (Level 1): greater than 95% efficiencyBlue mask (Level 1): greater than 95% efficiencyBlue mask (Level 2): greater than 98% efficiencyBlue mask (Level 3): greater than 98% efficiency |
| Differential Pressure (EN 14683:2019+AC:2019 Annex C) | To determine the differential pressure of the test article. | Level 1: < 5.0 mmH₂O/cm²Level 2: < 6.0 mmH₂O/cm²Level 3: < 6.0 mmH₂O/cm² | Yellow mask (Level 1): less than 5.0 mmH₂O/cm²White mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 2): less than 6.0 mmH₂O/cm²Blue mask (Level 3): less than 6.0 mmH₂O/cm² |
| Flammability (16 CFR Part 1610) | To evaluate the flammability of the test article. | Class 1 | Yellow mask (Level 1): Class 1White mask (Level 1): Class 1Blue mask: Level 1: Class 1, Level 2: Class 1, Level 3: Class 1 |
| Cytotoxicity (ISO 10993-5:2009) | To evaluate the cytotoxicity of the test article. | The cell culture test system is suitable if the observed responses to the negative control is grade 0 and to the positive control is at least grade 3. The sample meets the requirements of the test if the response to the sample is not greater than grade 2. | Under the conditions of this study, the cytotoxicity result was grade 0. The test article would be considered no cytotoxic potential. The negative controls, blank controls, and the positive controls performed as anticipated. |
| Sensitization (ISO 10993-10:2021) | To evaluate the sensitization of the test article. | Grades of 1 or greater in the test group generally indicated sensitization, provided grades of less than 1 are seen in the control animals. If grades of 1 or greater were noted in control animals, the reactions of test animals which exceeded the most severe reaction in control animals are presumed to be due to sensitization. | Under the conditions of this study, the guinea pig showed no sensitization reaction after the induction of test extracts and the positive rate is 0%. There was no evidence that the test article extracts would cause sensitization on guinea pig. |
| Irritation (ISO 10993-23:2021) | To evaluate the irritation of the test article. | The cumulative irritation indices in the range of 0 to 0.4 were determined to be in the irritation response category of "Negligible". | Under the conditions of the test, the cumulative stimulus value is 0.0, the test article caused no skin irritation to rabbits. The test article met the test requirements. |
Study Details (Applicable to Face Mask Device)
Given that the device is a medical face mask, the "study" primarily consists of non-clinical, laboratory-based performance and biocompatibility testing, not clinical trials or AI performance evaluations as would be done for software.
-
Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated in terms of number of masks or test replicates for each test, but standard test methodologies (e.g., ASTM F1862/F1862M-24, ASTM F2101-23) typically specify a minimum number of samples. The results are given for specific "lots" (e.g., Yellow mask (Level 1), White mask (Level 1), Blue mask (Level 1, 2, 3)), implying that multiple samples from these production lots were tested.
- Data Provenance: Not explicitly stated. The manufacturer is Winner Medical Co., Ltd. from Shenzhen, China. This indicates the testing was likely conducted in China or by labs accredited to perform these standards. The tests are "Non clinical tests," meaning they are laboratory experiments rather than human subject or retrospective studies.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For this type of device (medical mask), "ground truth" is established by adherence to validated, objective, and standardized laboratory test methodologies and measurements, not by expert human interpretation (like in imaging for AI). The tests measure physical and biological properties directly.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are relevant for human interpretation tasks (e.g., reading medical images) where there can be inter-reader variability. These are objective, quantitative laboratory tests.
-
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:
- Not Applicable. This is a physical medical device (mask), not an AI-powered diagnostic tool. MRMC studies are used to assess the performance of AI systems in combination with human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (mask), not an algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Objective Laboratory Measurements/Standards. The "ground truth" for this device is based on the objective measurements obtained through the specified ASTM, EN, CFR, and ISO standards (e.g., bacterial filtration efficiency percentage, differential pressure values, absence of penetration by synthetic blood, flammability class, cellular toxicity grading, sensitization response). These are empirical, quantitative, and qualitative results from standardized test protocols.
-
The sample size for the training set:
- Not Applicable. This is a physical device being tested against performance standards, not an AI/ML algorithm that requires a "training set."
-
How the ground truth for the training set was established:
- Not Applicable. As above, no training set for an algorithm is involved.
U.S. Food & Drug Administration 510(k) Clearance Letter
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
June 18, 2025
Winner Medical Co., Ltd.
Jiali Liu
Regulatory Affairs
Winner Industrial Park, No.660 Bulong Road, Longhua District
42nd Floor Building No 2, Huilong Business Center
Shenzhen, Guangdong 518109
China
Re: K250082
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: May 22, 2025
Received: May 22, 2025
Dear Jiali Liu:
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 (the 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 available 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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K250082 - Jiali Liu Page 2
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-
Page 3
K250082 - Jiali Liu Page 3
assistance/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,
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D.
Assistant Director
DHT4C: Division of Infection Control Devices
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250082
Device Name
Procedure mask/Surgical mask/Face mask
Indications for Use (Describe)
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.
Type of Use (Select one or both, as applicable)
☐ Prescription Use (Part 21 CFR 801 Subpart D)
☒ 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."
Page 5
510(k) Summary
Winner Medical Co., Ltd
K250082
1 / 11
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: K250082
1. Date of Preparation: June 06, 2025
2. Sponsor Identification
Winner Medical Co., Ltd.
42F, Building No.2, HBC Huilong Business Center, North Station Community, Minzhi Street,
Longhua District, 518131 Shenzhen, China
Contact Person: Jiali Liu
Position: Regulatory Affairs
Tel: +86-755-28138888
Email: lea.liu@winnemedical.com
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3. Identification of Subject Device
Trade Name: Procedure mask/Surgical mask/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 subject 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 subject device is available in one type, ear loop. The ear loops are made of polyester and spandex. The ear loops model is held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is made of Iron and polypropylene. 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. The ear loop masks are available in two size, 17.5 × 9.5 cm and 14.5 × 9.5 cm. And the colors for the ear loop mask are yellow, blue and white. The ear loop masks are available in level 1, level 2 and level 3 masks based on ASTM F2100-23. This is a single-use, disposable device, provided non-sterile. All specifications of the subject device are provided in table 1. The product configuration for level 1 yellow & level 1 blue & level 1 white & level 2 blue & level 3 blue face masks are provided in table 2.
Table 1 Procedure mask/Surgical mask/Face mask Description
| Product name | ASTM F2100-23 level | Ear strap type | Size (cm) | Color | Layers | Sterilization |
|---|---|---|---|---|---|---|
| Procedure mask/Surgical mask/Face mask | Level 1 | Ear loop | 17.5 × 9.5 | Yellow | 3 | Non-sterile |
| Blue | ||||||
| White | ||||||
| 14.5 × 9.5 | Yellow | |||||
| Blue | ||||||
| White | ||||||
| Level 2 | Ear loop | 17.5 × 9.5 | Blue | 3 | ||
| 14.5 × 9.5 | Blue | |||||
| Level 3 | Ear loop | 17.5 × 9.5 | Blue | 3 | ||
| 14.5 × 9.5 | Blue |
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Table 2 Product configuration
| Components | Level 1 white | Level 1 blue | Level 1 yellow | Level 2 blue | Level 3 blue | Same or Different | Remark |
|---|---|---|---|---|---|---|---|
| Inner layer of mask | polypropylene nonwoven fabric, white, 25 g/m² | polypropylene nonwoven fabric, white, 25 g/m² | polypropylene nonwoven fabric, white, 25 g/m² | polypropylene nonwoven fabric, white, 25 g/m² | polypropylene nonwoven fabric, white, 25 g/m² | Same | Purchased from the same supplier. |
| Middle layer of mask | polypropylene melt-blown nonwoven fabric, 25 g/m² | polypropylene melt-blown nonwoven fabric, 25 g/m² | polypropylene melt-blown nonwoven fabric, 25 g/m² | polypropylene melt-blown nonwoven fabric, 30 g/m² | polypropylene melt-blown nonwoven fabric, 33 g/m² | Different | Purchased from the same supplier. The only difference between them is square meter weight. |
| Outer layer of mask | polypropylene nonwoven fabric, white, 25 g/m² | polypropylene nonwoven fabric, blue, 25 g/m² | polypropylene nonwoven fabric, yellow, 25 g/m² | polypropylene nonwoven fabric, blue, 30 g/m² | polypropylene nonwoven fabric, blue, 35 g/m² | Different | Purchased from the same supplier. The differences between them are square meter weight and color. |
| White ear loop | Polyester and spandex | Polyester and spandex | Polyester and spandex | Polyester and spandex | Polyester and spandex | Same | Purchased from the same supplier. |
| Nose clip | Iron and polypropylene | Iron and polypropylene | Iron and polypropylene | Iron and polypropylene | Iron and polypropylene | Same | Purchased from the same supplier. |
4. Identification of Predicate Device
K220194 Procedure mask/Surgical mask/Face mask; 21 CFR 878.4040 FXX Mask, Surgical (For level 1 and level 2).
K223232 Procedure mask/Surgical mask/Face mask; 21 CFR 878.4040 FXX Mask, Surgical (For level 3).
5. Summary of Non-Clinical Test
Non clinical tests were conducted to verify that the subject device met all design specifications as was same/similar to the predicate device. The test results demonstrated that the subject device complies with the following standards:
ASTM F1862/F1862M: 2024 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
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ASTM F2101-23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
ASTM F2100-23 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 10993-1: 2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process;
ISO 10993-5: 2009 Biological evaluation of medical device - Part 5: Tests for in vitro cytotoxicity;
ISO 10993-10: 2021 Biological evaluation of medical device - Part 10: Tests for skin sensitization;
ISO 10993-23: 2021 Biological evaluation of medical device - Part 23: Tests for irritation.
Table 3 Summary of Performance Testing
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Resistance to Penetration by Synthetic blood | The test was performed in accordance with ASTM F1862/F1862M-24 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) to evaluate the effectiveness of the test article from possible exposure to blood and other body fluids. | Level 1: No penetration at 80 mmHgLevel 2: No penetration at 120 mmHgLevel 3: No penetration at 160 mmHg | The results for all lots are as follows:Yellow mask (Level 1): Pass at 80 mmHgWhite mask (Level 1): Pass at 80 mmHgBlue mask:Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg |
| Particulate Filtration Efficiency | The test was performed in accordance with ASTM F3502-24 Standard Specification for Barrier Face Coverings to determine the particle filtration efficiency (PFE) of the test article. | Level 1: ≥ 80%Level 2: ≥ 85%Level 3: ≥ 85% | Yellow mask (Level 1): greater than 80% efficiencyWhite mask (Level 1): greater than 80% efficiencyBlue mask (Level 1): greater than 80% efficiencyBlue mask (Level 2): greater than 85% efficiencyBlue mask (Level 3): |
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greater than 85% efficiency
| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Bacterial Filtration Efficiency | The test was performed in accordance with ASTM F2101: 23 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, using a Biological Aerosol of Staphylococcus aureus to determine the bacterial filtration efficiency (BFE) of the test article. | Level 1: ≥ 95%Level 2: ≥ 98%Level 3: ≥ 98% | Yellow mask (Level 1): greater than 95% efficiencyWhite mask (Level 1): greater than 95% efficiencyBlue mask (Level 1): greater than 95% efficiencyBlue mask (Level 2): greater than 98% efficiencyBlue mask (Level 3): greater than 98% efficiency |
| Differential Pressure | The test was performed in accordance with EN 14683:2019+AC: 2019 Annex C Medical face masks - Requirements and test methods to determine the differential pressure of the test article. | Level 1: < 5.0 mmH₂O/cm²Level 2: < 6.0 mmH₂O/cm²Level 3: < 6.0 mmH₂O/cm² | Yellow mask (Level 1): less than 5.0 mmH₂O/cm²White mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 1): less than 5.0 mmH₂O/cm²Blue mask (Level 2): less than 6.0 mmH₂O/cm²Blue mask (Level 3): less than 6.0 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 | The results for all Lot es are as follows:Yellow mask (Level 1): Class 1White mask (Level 1): Class 1Blue mask:Level 1: Class 1Level 2: Class 1Level 3: Class 1 |
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| Test Methodology | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| 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 cell culture test system is suitable if the observed responses to the negative control is grade 0 and to the positive control is at least grade 3. The sample meets the requirements of the test if the response to the sample is not greater than grade 2. | Under the conditions of this study, the cytotoxicity result was grade 0. The test article would be considered no cytotoxic potential. The negative controls, blank controls, and the positive controls performed as anticipated. |
| Sensitization | The test was performed in accordance with ISO 10993-10 Fourth Edition 2021-11 Biological evaluation of medical devices - Part 10: Tests for skin sensitization to evaluate the sensitization of the test article. | Grades of 1 or greater in the test group generally indicated sensitization, provided grades of less than 1 are seen in the control animals. If grades of 1 or greater were noted in control animals, the reactions of test animals which exceeded the most severe reaction in control animals are presumed to be due to sensitization. | Under the conditions of this study, the guinea pig showed no sensitization reaction after the induction of test extracts and the positive rate is 0%. There was no evidence that the test article extracts would cause sensitization on guinea pig. |
| Irritation | The test was performed in accordance with ISO 10993-10 Fourth Edition 2021-11 Biological evaluation of medical devices - Part 23: Tests for irritation to evaluate the irritation of the test article. | The cumulative irritation indices in the range of 0 to 0.4 were determined to be in the irritation response category of "Negligible". | Under the conditions of the test, the cumulative stimulus value is 0.0, the test article caused no skin irritation to rabbits. The test article met the test requirements. |
6. Clinical Test Conclusion
No clinical study is included in this submission.
7. Technological Characteristics Comparison
Table 4 Comparison of Procedure mask/Surgical mask/Face mask-Level 1 and Level 2
| ITEM | Subject Device K25002 | Predicate Device K220194 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indications for Use | The Procedure mask/Surgical mask/Face mask is intended to be worn to protect both the patient | The Procedure mask/Surgical mask/Face mask is intended to be worn to protect both the patient | Same |
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| ITEM | Subject Device K25002 | Predicate Device K220194 | Remark |
|---|---|---|---|
| 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. | 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 | ||
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Ear loop / Tie-on | Same |
| Dimension | Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 178 mmBody: 145 mm × 95 mm, nose clip: 85 mm, Ear-loop: 145 mm | Ear loops:Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 178 mmBody: 145 mm × 90 mm, nose clip: 85 mm, Ear-loop: 145 mmTie-on:Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 900 mm | Different |
| ASTM F2100 Level | Level 1 Level 2 | Level 1 Level 2 | Same |
| Fluid Resistance | Pass at 80 mmHg Pass at 120 mmHg | Pass at 80 mmHg Pass at 120 mmHg | Same |
| Particulate efficiency level | Yellow mask (Level 1): The min result is 90%White mask (Level 1): The min result is 85%Blue mask (Level 1): The min result is 85%Blue mask (Level 2): The min result is 91% | Blue mask: Pass at 96.05%Black mask: Pass at 96.03%Blue mask: Pass at 98.78%Black mask: Pass at 98.75% | Different |
| Bacterial filtration level | Yellow mask (Level 1): The min result is 99.6%White mask (Level 1): The min result is 99.4%Blue mask (Level 1): The min result is 99.5%Blue mask (Level 2): The min result is 99.9% | Blue mask: Pass at 98.25%Black mask: Pass at 98.25%Blue mask: Pass at 98.72%Black mask: Pass at 98.73% | Different |
| Differential pressure | Yellow mask (Level 1): The max result is 3.8 mmH₂O/cm²White mask (Level 1): Blue mask (Level 2): The max result is 5.1 mmH₂O/cm² | Blue mask: Pass at 3.5 mmH₂O/cm²Black mask: Pass at 3.5Blue mask: Pass at 3.5 mmH₂O/cm²Black mask: Pass at 3.6 | Different |
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| ITEM | Subject Device K25002 | Predicate Device K220194 | Remark |
|---|---|---|---|
| The max result is 4.6 mmH₂O/cm²Blue mask (Level 1): The max result is 4.5 mmH₂O/cm² | mmH₂O/cm² 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 | Polyester and spandex | Different |
| Nose clip | Iron and polypropylene | Iron and polypropylene | |
| Mask body | |||
| Outer material | 25 g/m² polypropylene nonwoven30 g/m² polypropylene nonwoven | 25 g/m² polypropylene nonwoven30 g/m² polypropylene nonwoven | |
| Middle material | 25 g/m² polypropylene melt-blown nonwoven30 g/m² polypropylene melt-blown nonwoven | 25 g/m² polypropylene melt-blown nonwoven30 g/m² polypropylene melt-blown nonwoven | |
| Inner material | 25 g/m² white polypropylene nonwoven25 g/m² white polypropylene nonwoven | 25 g/m² polypropylene nonwoven30 g/m² polypropylene nonwoven | |
| Colors | Yellow; Blue; White | Blue; Black | Different |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the device was non-cytotoxic. | Under the conditions of the study, the device was non-cytotoxic. | Same |
| Sensitization | Under the conditions of the study, the device was non-sensitizing. | Under the conditions of the study, the device was non-sensitizing. | Same |
| Irritation | Under the conditions of the study, the device was non-irritating. | Under the conditions of the study, the device was non-irritating. | Same |
| Sterilization Method | Single use, Non-sterile, No shelf life claimed | Single use, Non-sterile, No shelf life claimed | Same |
Different - Dimension
The dimension for the subject device is different from predicate device, it is only minor size adjustments have been made, this difference in dimension will not affect the safety and effectiveness of the subject device.
Different - Particulate efficiency
The test method and test result for particulate filtration efficiency for the subject device is different from the predicate device. The difference in test method and test result is not a result of a change in the product, but rather a difference caused by the update of the standard from ASTM-F2100-19 to ASTM-F2100-23. However, the test result for the subject device can meet the requirements of level 1/level 2 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the subject device is different from the predicate device. However, the test
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result for the subject device can meet the requirements of level 1/level 2 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Differential pressure
The test result for differential pressure for the subject device is different from the predicate device. However, the test result for the subject device can meet the requirements of level 1/level 2 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Materials
The material for the subject device is different from predicate device. Only the grammage of the inner polypropylene nonwoven of the level 2 masks is different, the rest of the masks are not different. By changing the grammage, the biocompatibility test has been performed on the subject device, the test result for the subject device can meet the requirements based on ASTM F2100-23 and the result does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the subject device.
Different - Colors
The colors of subject device are provided in yellow, blue and white, while the predicate device is blue and black. However, 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 subject device.
Table 5 Comparison of Procedure mask/Surgical mask/Face mask-Level 3
| ITEM | Subject Device K250082 | Predicate Device K223232 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| 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. | 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 | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Ear loop / Tie-on | Same |
| Dimension | Ear loops:Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 178 mmBody: 145 mm × 95 mm, nose clip: 85 mm, | Ear loops:Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 178 mmBody: 145 mm × 90 mm, nose clip: 85 mm, | Different |
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| ITEM | Subject Device K250082 | Predicate Device K223232 | Remark |
|---|---|---|---|
| Ear-loop: 145 mm | Ear-loop: 145 mmTie-on:Body: 175 mm × 95 mm, nose clip: 110 mm, Ear-loop: 900 mm | ||
| ASTM F2100 Level | Level 3 | Level 3 | Same |
| Fluid Resistance | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| Particulate efficiency level | Blue mask (Level 3): The min result is 92% | Blue mask: Pass at 99.87%Black mask: Pass at 98.90% | Different |
| Bacterial filtration level | Blue mask (Level 3): The min result is 99.8% | Blue mask: Pass at 99.75%Black mask: Pass at 99.03% | Different |
| Differential pressure | Blue mask (Level 3): The max result is 5.3 mmH₂O/cm² | Blue mask: Pass at 4.8 mmH₂O/cm²Black mask: Pass at 3.7 mmH₂O/cm² | Different |
| 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 | Polyester and spandex | Different |
| Nose clip | Iron and polypropylene | Iron and polypropylene | |
| Mask body | |||
| Outer material | 35 g/m² blue polypropylene nonwoven | 35 g/m² polypropylene nonwoven Blue Masterbatch (ratio: 0.8%) | |
| Middle material | 33 g/m² polypropylene melt-blown nonwoven | 33 g/m² polypropylene melt-blown nonwoven | |
| Inner material | 25 g/m² white polypropylene nonwoven | 25 g/m² polypropylene nonwoven | |
| Colors | Blue | Blue; Black | Similar |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the device was non-cytotoxic. | Under the conditions of the study, the device was non-cytotoxic. | Same |
| Sensitization | Under the conditions of the study, the device was non-sensitizing. | Under the conditions of the study, the device was non-sensitizing. | Same |
| Irritation | Under the conditions of the study, the device was non-irritating. | Under the conditions of the study, the device was non-irritating. | Same |
| Sterilization Method | Single use, Non-sterile, No shelf life claimed | Single use, Non-sterile, No shelf life claimed | Same |
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Different - Dimension
The dimension for the subject device is different from predicate device, it is only minor size adjustments have been made, this difference in dimension will not affect the safety and effectiveness of the subject device.
Different - Particulate efficiency
The test method and test result for particulate filtration efficiency for the subject device is different from the predicate device. The difference in test method and test result is not a result of a change in the product, but rather a difference caused by the update of the standard from ASTM-F2100-19 to ASTM-F2100-23. However, the test result for the subject device can meet the requirements of level 3 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Bacterial filtration efficiency
The test result for bacterial filtration efficiency for the subject device is different from the predicate device. However, the test result for the subject device can meet the requirements of level 3 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Differential pressure
The test result for differential pressure for the subject device is different from the predicate device. However, the test result for the subject device can meet the requirements of level 3 mask based on ASTM F2100-23. Thus, this difference will not affect the safety and effectiveness of subject device.
Different - Materials
The material for the subject device is different from predicate device. The outer material of the subject device is 35 g/m² blue polypropylene nonwoven and the predicate device is 35 g/m² polypropylene nonwoven Blue Masterbatch (ratio: 0.8%). By changing the outer material, biocompatibility test has been performed on the subject device, the test result for the subject device can meet the requirements based on ASTM F2100-23 and the result does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the subject device.
8. Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device K220194 and K223232.
§ 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.