(316 days)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
The provided text describes the regulatory clearance for a Medical Face Mask (K210679) and details the non-clinical tests performed to demonstrate its substantial equivalence to a predicate device (K200847). This is a submission for a physical medical device, not an AI/ML-driven device, so many of the requested elements for AI/ML studies are not applicable.
Here's a breakdown of the information that is available and a note on the missing information, tailored to the AI/ML context of your request:
Acceptance Criteria and Reported Device Performance
The device is a medical face mask, and its performance is evaluated against established standards for materials used in such masks.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance (K2106679) | Result |
|---|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | Evaluate resistance to penetration by synthetic blood. | 29 Out of 32 pass at 120 mmHg | Lot 1: 32 Out of 32 pass at 120 mmHgLot 2: 32 Out of 32 pass at 120 mmHgLot 3: 32 Out of 32 pass at 120 mmHg | Pass |
| Particulate Filtration Efficiency (ASTM F2299) | Measure initial particulate filtration efficiency using monodispersed aerosols (0.1µm latex spheres). | ≥ 98% | Lot 1: 98.9%Lot 2: 98.9%Lot 3: 98.7% | Pass |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | Determine bacterial filtration efficiency using a biological aerosol of Staphylococcus Aureus. | ≥ 98% | Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | Pass |
| Flammability (16 CFR 1610) | Determine flammability characteristics. | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Pass |
| Differential Pressure (Delta P) (EN 14683:2019) | Measure differential pressure between the inside and outside of the mask. | < 6.0 mmH2O/cm² | Lot 1: 3.0 mmH2O/cm²Lot 2: 3.1 mmH2O/cm²Lot 3: 3.3 mmH2O/cm² | Pass |
| Cytotoxicity (ISO 10993-5) | Determine biological reactivity of mammalian cell culture (mouse fibroblast L929cells). | Non-cytotoxic | Non-cytotoxic | Pass |
| Irritation (ISO 10993-10) | Evaluate potential skin irritation from extract on rabbit skin. | Non-irritating | Non-Irritating | Pass |
| Sensitization (ISO 10993-10) | Evaluate potential for extracts to cause skin sensitization in guinea pig. | Non-sensitizing | Non-sensitizing | Pass |
Information Relevant to AI/ML Studies (and why it's mostly absent):
This document describes the regulatory clearance for a physical medical face mask, not an AI/ML powered device. Therefore, information points 2 through 9, which are specifically relevant to the evaluation of AI/ML algorithms, are not applicable and are consequently missing from this submission.
- Sample size used for the test set and data provenance: Not applicable. Performance is evaluated on physical samples/lots of the mask material against defined standards. The data provenance is laboratory testing conducted according to specified ASTM, CFR, EN, and ISO standards. The country of origin of the device manufacturer is China.
- Number of experts used to establish ground truth & qualifications: Not applicable. Ground truth for the physical properties of the mask (e.g., filtration efficiency, fluid resistance) is established by standardized laboratory testing methods, not by expert consensus readings of medical images.
- Adjudication method for the test set: Not applicable. Performance is measured objectively through lab tests.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. This type of study involves human readers interpreting medical images, optionally with AI assistance. The device is a physical mask.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable. There is no algorithm.
- Type of ground truth used: Ground truth is defined by the objective measurements and pass/fail criteria outlined in the relevant ASTM, CFR, EN, and ISO standards for physical properties and biocompatibility.
- Sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
The provided document details the testing and acceptance criteria for a physical medical device (face mask). It successfully demonstrates that the device meets the specified performance criteria through a series of standardized laboratory tests for filtration, fluid resistance, flammability, breathability, and biocompatibility. The framework of questions you've provided is designed for AI/ML devices, hence much of the requested information (e.g., expert readers, adjudication, training data) is not present in this submission.
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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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
January 18, 2022
Wuxi Yushou Medical Appliances Co.,Ltd. Xiaoling Dai QA&QC Manager No.115 Nongxinhe Road, Xishan District, Wuxi City, Jiangsu Province, China. Wuxi, Jiangsu 214200 China
Re: K210679
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: January 10, 2022
Dear Xiaoling Dai:
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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Clarence W. Murray, III, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210679
Device Name Medical face mask
Indications for Use (Describe)
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
| Type of Use (Select one or both, as applicable) | Demonstration Use (Ref 21 CFR 201 Subpart D) Over-The-Counter Use (21 CFR 201 Subpart C) | Demonstration Use (Ref 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
|---|---|---|---|
| Demonstration Use (Ref 21 CFR 201 Subpart D) | |||
| Over-The-Counter Use (21 CFR 201 Subpart C) |
__ Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Submission number: K210679
510(k) Summary
Submitter Information 1.
Company Name:Wuxi Yushou Medical Appliances Co.,Ltd.
Address: No.115 Nongxinhe Road, Xishan District, Wuxi City, Jiangsu Province, China.
Phone:+86-510-83777555
Contact Person (including title): Xiaoling Dai (QA&QC Manager)
E-mail : Kiwi-xu@isosh.com
Subject Device Information
- Traditional Type of 510(k):
- Common Name: Surgical face mask
- Trade Name: Medical face mask
- Classification Name: Mask,Surgical
- Review Panel: General Hospital
- Product Code: FXX
- Regulation Number: 21 CFR 878.4040
2
- Regulation Class:
2. Predicate Device Information
- Sponsor: MEXPO INTERNATIONAL INC.
- Surgical Face Mask Common Name:
- Trade Name: Surgical Face Mask
- 510(k) number: K200847
- Review Panel: General Hospital
- Product Code: FXX
- Regulation Number: 21 CFR 878.4040
- Regulation Class: Class II
-
- Device Description
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510(k) Submission number: K210679
The medical face masks are single use, 3 layers, flat-pleated style with ear loops and nose piece. The outer layer and inner facing layer of face mask consist of spun-bond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains ear loops to secure the mask over the user's face and mouth with nose piece to firmly fit over the nose.
4. Intended Use
When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only.
5. Test Summary
Medical face mask has been evaluated the safety and performance by lab bench testing according to the following standards:
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Surgical face masks to Penetration by Particulates Using Latex Spheres.
- ASTM F1862 Standard test method for resistance of Surgical face masks to penetration by synthetic blood (Horizontal projection of fixed volume at a known velocity)
- ASTM F 2101-19 Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Surgical face mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- During use, the Non Woven Face Mask will directly contact with user's skin, so we have it tested to demonstrate conformance to the following standards. ISO 10993-5, Biological Evaluation Of Medical Devices -- Part 5: Tests For InVitro Cytotoxicity ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
6. Summary of Comparison and Technological Characteristics
Table 1 - General Comparison
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| Elements of Comparison | Subject Device(K210679) | Predicate Device(K200847) | Comments | |
|---|---|---|---|---|
| Product Name | Medical face mask | Surgical face mask | -- | |
| General Comparison | ||||
| Intended Use | When properly worn, the medical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate materials. This device is non sterile and for single use only. | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | Same | |
| Model | 3 Ply, Ear Loops, Flat-Pleated Style | 3 Ply, Ear Loops, Flat-Pleated Style | Same | |
| Material | Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | Single Galvanize Wire, Coated By PE | Single Galvanize Wire, Coated By PE | Same | |
| Ear loops | Spandex | not made with natural rubber latex | Same | |
| Color | Blue | White | DifferentNote 1 | |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.0cm ± 0.5cm | SimilarNote 2 | |
| Dimension (Length) | 17.5cm ± 0.5cm | 17.5cm ± 0.5cm | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Fluid Resistance PerformanceASTM F 1862 | Lot 1: 32 Out of 32 pass at 120 mmHgLot 2: 32 Out of 32 pass at 120 mmHgLot 3: 32 Out of 32 pass at 120 mmHg | 30 Out of 32 pass at 120 mmHg | Same | |
| Elements ofComparison | Subject Device(K210679) | Predicate Device(K200847) | Comments | |
| Particulate FiltrationEfficiencyASTM F 2299 | Lot 1:98.9%Lot 2:98.9%Lot 3: 98.7% | 99.9% | Same | |
| Bacterial FiltrationEfficiencyASTM F2101 | Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | > 99.9% | Same | |
| Differential Pressure(Delta P)EN 14683:2019+AC:2019 | Lot 1: 3.0 mmH2 0/cm²Lot 2: 3.1 mmH2 0/cm²Lot 3: 3.3 mmH2 0/cm² | 3.0 mmH2 0/cm² | Same | |
| Flammability16CFR 1610 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Class 1 | Same | |
| Cytotoxicity | Comply with ISO 10993-5Non cytotoxic | Comply with ISO 10993-5Non cytotoxic | Same | |
| Irritation | Comply with ISO 10993-10Non irritating | Comply with ISO 10993- 10Non irritating | Same | |
| Sensitization | Comply with ISO 10993-10Non sensitizing | Comply with ISO 10993- 10Non sensitizing | Same |
510(k) Submission number: K210679
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510(k) Submission number: K210679
Table 2 - Performance Testing
| Test Methodology | Purpose | ProposedDevice | AcceptanceCriteria | Result |
|---|---|---|---|---|
| Fluid ResistancePerformance(ASTM F1862) | The test method is used toevaluate the resistance ofmedical face masks topenetration by the impact of asmall volume(~2 mL) ofhigh-velocity stream ofsynthetic blood. The pass/faildeterminations are based onvisual detection of syntheticblood penetration. | Lot 1: 32 Out of32 pass at 120mmHgLot 2: 32 Out of32 pass at 120mmHgLot 3: 32 Out of32 pass at 120mmHg | 29 Out of 32pass at 120mmHg | Pass |
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| Sponsor: | Wuxi Yushou Medical Appliances Co., Ltd. | ||||
|---|---|---|---|---|---|
| Subject Device: | Medical face mask, model: Flat type | ||||
| File No.: | 510(k) submission report, Chapter 6 | ||||
| 510(k) Submission number: | K210679-S002 | ||||
| ParticulateFiltrationEfficiency(ASTM F2299) | The purpose of this testmethod is to measure theinitial partical filtrationefficiency of materials usingmonodispersed aerosolscontaining suspended latexspheres particulates of 0.1µmdiameter. | Lot 1: 98.9%Lot 2: 98.9 %Lot 3: 98.7 % | ≥ 98% | Pass | |
| Bacterial FiltrationEfficiency(ASTM F2101) | The purpose of this testmethod is to determine thebacterial filtration efficiency ofthe mask as specified inASTM F2101. | Lot 1: 99.9%Lot 2: 99.9%Lot 3: 99.9% | ≥ 98% | Pass | |
| Flammability(16 CFR 1610) | The purpose of this testmethod is to determine theflammability charateristics ofthe mask as specified in 16CFR Part 1610. Materials inthe construction of medicalface masks shall meet therequirements for Class 1,normal flammability specifiedin 16 CFR Part 1610. | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 | Class 1 | Pass | |
| DifferentialPressure(EN 14683:2019) | The purpose of this test s tomeasure the differentialpressure between the insideand outside of the mask. | Lot 1: 3.0 mmH20/cm²Lot 2: 3.1 mmH20/cm²Lot 3: 3.3 mmH20/cm² | < 6.0mmH20/cm² | Pass |
Table 3 - Biocompatibility Testing
| TestMethodology | Purpose | Proposed Device | Acceptance Criteria | Result |
|---|---|---|---|---|
| --------------------- | --------- | ----------------- | --------------------- | -------- |
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Wuxi Yushou Medical Appliances Co.,Ltd. Sponsor: Subject Device: Medical face mask,model:Flat type
| 510(k) Submission number : | K210679 |
|---|---|
| ---------------------------- | --------- |
| Cytotoxicity(ISO 10993-5) | The purpose of the test is to determinethe biologicalreactivity of amammalian cellculture (mouse fibroblastL929cells) in response tothe test article. | Non-Cytotoxic | Under the conditions ofthe study,non-cytotoxicity | Pass |
|---|---|---|---|---|
| Irritation(ISO 10993-10) | To evaluate the potentialskin irritation caused bythe extraction of the testarticle extract contactingwith the skin surface ofrabbits. | NonSensitizing | Under the conditions of thestudy, non-irritation | Pass |
| Sensitization(ISO 10993-10) | To evaluate the potentialof test article extracts tocause skin sensitizationin the guinea pigaccording to GPMTmethod. | Non-Irritating | Under the conditions of thestudy, non-sensitization | Pass |
Note 1: The composition of colorants is pigment blue 15:3 (CAS No.147-14-8), the MSDS of color
additive used in our manufacturing process is shown as attachment 4.
Note 2:The width dimension of subject is a little longer than that of predicate device, this difference does not affect the safety and effectiveness.
7. Non-clinical Tests Performed on the Proposed Device
The proposed device was tested and conformed to the following standards and the
requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket
Notification [510(k)] Submission issued on March 5, 2004.
8. Summary of Clinical Testing
There is no clinical study included in this submission.
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K210679, the medical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200847.
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510(k) Submission number: K210679
10. Summary Prepared Date
30 November 2021
§ 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.