(454 days)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
The surgical face masks are non-sterile, 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 Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
The provided document is a 510(k) summary for a surgical face mask (K203161), demonstrating substantial equivalence to a predicate device (K202061). This type of regulatory submission focuses on showing that a new device is as safe and effective as a legally marketed predicate device, primarily through non-clinical performance and material comparisons. It does not contain information about a study involving human readers or AI assistance. Therefore, I will focus on the performance criteria and the non-clinical studies conducted for this device.
Here's the breakdown of the acceptance criteria and the study results:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Method | Acceptance Criteria | Reported Device Performance (Subject Device - 3 Lots) |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 (Resistance of Surgical face masks to penetration by synthetic blood) | (A) There are no burn times; or (B) There is only one burn time and it is equal to or greater than 3.5 seconds; or (C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. For the purpose of comparison to predicate, the reported criteria is 80 mmHg. | Lot 1: 32 Out of 32 pass at 80 mmHgLot 2: 32 Out of 32 pass at 80 mmHgLot 3: 32 Out of 32 pass at 80 mmHg |
| Particulate Filtration Efficiency (%) | ASTM F2299 (Initial Efficiency of Materials to Penetration by Particulates) | ≥ 95% | Lot 1: Average 96.6%Lot 2: Average 96.1%Lot 3: Average 96.2% |
| Bacterial Filtration Efficiency (%) | ASTM F2101 (Evaluating the Bacterial Filtration Efficiency (BFE)) | ≥ 95% | Lot 1: Average 99.5%Lot 2: Average 99.4%Lot 3: Average 99.4% |
| Flammability Class | 16 CFR 1610 (STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES) | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
| Differential Pressure (Delta-P) (mm H2O/cm²) | ASTM F2100-19 / EN 14683:2019+AC (2019)(E), Annex C (Determine breathing resistance) | < 5.0 mmH2O/cm² | Lot 1: Average 3.9 mmH2O/cm²Lot 2: Average 3.8 mmH2O/cm²Lot 3: Average 4.0 mmH2O/cm² |
| In Vitro Cytotoxicity | ISO 10993-5: 2009 (MTT method) | Viability reduced to <70% of the blank indicates cytotoxic potential. The test article should have at least the same or a higher viability than the 100% extract. | Non-cytotoxic |
| Skin Sensitization | ISO 10993-10:2010 (Guinea Pig Maximization) | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. | Non-sensitizing |
| Skin Irritation | ISO 10993-10:2010 (Skin Irritation Test) | Primary irritation index for the test article should demonstrate non-irritation when compared to controls. | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Performance Testing: The document states that "three lots of product" were tested for the physical performance criteria (Fluid Resistance, Particulate Filtration, Bacterial Filtration, Flammability, Differential Pressure). Specific sample sizes per lot for each test are not explicitly stated, but for Fluid Resistance, it mentions "32 Out of 32 pass" for each lot, indicating a sample size of 32 for that specific test within each lot.
- Biocompatibility Testing:
- In Vitro Cytotoxicity: The specific number of samples (e.g., cell cultures, extracts) tested is not detailed, but it's implied by "the test article" and "the 100% extract."
- Skin Sensitization (Guinea Pig Maximization): This method inherently uses animal cohorts (guinea pigs). The exact number of animals in the test group and control group is not specified in the provided text.
- Skin Irritation: This test also uses animal cohorts. The document mentions "individual animals" and "number of animals" for calculating scores, but the specific count is not provided.
- Data Provenance: The document does not specify the country of origin of the data for these tests or whether they were retrospective or prospective. Given that the manufacturer is in Wuhan, China, and the submission is to the FDA, the testing would likely have been conducted in accredited labs, potentially in China or elsewhere, to internationally recognized standards. All tests are inherently prospective in nature as they involve testing newly manufactured product.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable to the provided document. The studies performed are non-clinical, laboratory bench tests and biological evaluations, not studies involving human perception or interpretation (like radiology image analysis). Therefore, there is no "ground truth" established by experts in the context of clinical interpretation, but rather by standardized laboratory procedures and measurements.
4. Adjudication Method for the Test Set
This information is not applicable. Adjudication methods are relevant for studies where human interpretation or consensus is required (e.g., blinded reads, pathology reviews). The tests described are objective, standardized laboratory measurements.
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
There was no MRMC comparative effectiveness study and no mention of AI assistance. This document is for a physical medical device (surgical face mask), not an AI/software as a medical device.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is a physical surgical face mask, not an algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the performance tests is established by objective, standardized laboratory measurements according to the specified ASTM, EN, and ISO standards.
- For Fluid Resistance, Particulate Filtration, Bacterial Filtration, Flammability, and Differential Pressure, the ground truth is the quantitative measurement obtained through the defined test method (e.g., percentage efficiency, pressure drop, burn class, pass/fail at a specific mmHg).
- For Biocompatibility (Cytotoxicity, Sensitization, Irritation), the ground truth is the biological response observed and quantified (e.g., cell viability, skin reactions/grades) according to ISO standards, which determines if the material is non-cytotoxic, non-sensitizing, and non-irritating.
8. The Sample Size for the Training Set
This information is not applicable. There is no "training set" as this is a physical device being evaluated for safety and performance through direct testing, not a machine learning model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the reasons stated in point 8.
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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 & 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.
January 20, 2022
Wuhan Raytex Protection CO., LTD Maggie Yao General Manager RM1201,Mingchuang Building,Greenland,Heping Avenue, Wuchang District Wuhan, Hubei 430060 China
Re: K203161
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 25, 2021 Received: December 16, 2021
Dear Maggie Yao:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Clarence W. Murray III, PhD 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) K203161
Device Name Surgical face mask
Indications for Use (Describe)
When properly worn, the surgical face masks are intended to patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non-sterile and for single use only.
| 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
Summary Prepared Date
19 January 2022
Submitter Information 1.
Sponsor Name: WUHAN RAYTEX PROTECTION CO., LTD
Address: RM1201,Mingchuang Building,Greenland,Heping Avenue,Wuchang District,Wuhan,Hubei
Province,430060,China.
Contact Person:Maggie Yao (General Manager)
Phone: +86-27 87263395
Fax: +86-27 88398709
E-mail:sales@vicogard.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical face mask |
| Trade Name: | Surgical face mask |
| 510(k) number: | K203161 |
| Classification Name: | Mask,Surgical |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | Class II |
3. Predicate Device Information
| Sponsor: | Jiangsu Province Jianerkang Medical Dressing Co., Ltd |
|---|---|
| Common Name: | Medical Face Mask |
| Trade Name: | Medical Face Mask |
| 510(k) number: | K202061 |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
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Regulation Class: Class II
4. Device Description
The surgical face masks are non-sterile, 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 Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the user's face and mouth with nose piece to firmly fit over the nose.
5. Intended Use
When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and particulate material. This device is non sterile and for single use only.
6. Summary of Comparison and Technological Characteristics
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
|---|---|---|---|---|
| Product Name | Surgical face mask | Medical face mask | -- | |
| 510(k) number | K203161 | K202061 | -- | |
| General Comparison | ||||
| Intended Use | When properly worn, thesurgical face masks areintended to protect bothpatient and healthcareworkers from transfer ofmicroorganisms, body fluidsand particulate material.Thisdevice is non-sterile and forsingle use only. | The medical face mask isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials in infection controlpractices to reduce thepotential exposure to bloodand body fluids. It is for single-useand provided non-sterile. | Same | |
| Model | Flat type | Flat Pleated | Same | |
| Design features | Ear loop | Ear loop | Same | |
| Layers | 3 | 3 | Same | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| Target population | Adults | Adults | Same | |
| Material | Outer facing layer | polypropylene | polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene | Same | |
| Inner facing layer | polypropylene | polypropylene | Same | |
| Nose piece | Single Galvanize Wire, Coated by PE | Polypropylene coated steel wire | Note 1 | |
| Ear loops | Spandex and nylon | Spandex and nylon | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.5cm | Same | |
| Dimension (Length) | 17.5cm ± 0.5cm | 17.5cm | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level 1 | Level 1 | Same | |
| Synthetic BloodPenetrationResistanceASTM F 1862 | Lot 1: 32 Out of 32 pass at80 mmHgLot 2: 32 Out of 32 pass at 80 mmHgLot 3: 32 Out of 32 pass at80 mmHg | 80 mmHg | Same | |
| Particulate FiltrationEfficiencyASTM F 2299 | Lot 1:Average 96.6%Lot 2:Average 96.1 %Lot 3:Average 96.2% | Average 96.09% | Same | |
| Bacterial FiltrationEfficiencyASTM F2101 | Lot 1: Average 99.5%Lot 2: Average 99.4%Lot 3: Average 99.4% | Average 99.8% | Same | |
| Differential Pressure(Delta P)EN 14683:2019+AC: | Lot 1: Average 3.9 mmH2 0/cm²Lot 2: Average 3.8 mmH2 | Average 3.9 mmH2 0/cm² | Same | |
| Elements ofComparison | Subject Device | Predicate Device | Verdict | |
| 2019 | 0/cm²Lot 3: Average 4.0 mmH20/cm² | |||
| 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 |
Table 1 - General Comparison
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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:
Subject Device: File No.:
Surgical face mask,model:Flat type 510(k) submission report,
510(k) Submission number: K203161
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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:
Subject Device: Surgical face mask,model:Flat type
File No.: 510(k) submission report,
510(k) Submission number: K203161
Note 1: The nose piece material of the subject device is Single Galvanize Wire, Coated by PE. The predicate device uses polypropylene coated steel wire. The nose piece does not directly contact the user ' s skin. Biocompatibility testing was conducted on the final device. Performance testing was conducted according to ASTM F2100-19.
Otherwise, all of the specifications and materials of the subject device, Surgical face mask, are the same as the predicate device K202061.
Table 2 - Performance Testing
We have tested three lots of product. The data below is one of these performance tests.
Surgical 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 ynthetic 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.
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- 16 CFR Part 1610 STANDARD FOR THE FLAMMABILITY OF CLOTHING TEXTILES
- Determine breathing resistance or differential pressure as directed in EN 14683:2019,AnnexC
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
| Item | Test Method | Acceptance Criteria | Result |
|---|---|---|---|
| FluidResistancePerformance(mmHg) | ASTM F1862 | (A) There are no burntimes; or(B) There is onlyone burn time and it isequal to or greater than 3.5seconds; or(C) The averageburn time oftwo or more specimens isequal to or greater than 3.5seconds. | Lot 1: 32 Out of 32 passat 80 mmHgLot 2: 32 Out of 32 passat 80 mmHgLot 3: 32 Out of 32 passat 80 mmHg |
| ParticulateFiltrationEfficiencyPerformance (%) | ASTM F2299 | ≥ 95% | Lot 1:Average 96.6 % Lot2:Average 96.1% Lot 3:Average96.2% |
| Bacterial FiltrationEfficiencyPerformance (%) | ASTM F2101 | ≥ 95% | Lot 1: Average 99.5%Lot 2: Average 99.4%Lot 3: Average 99.4% |
| Flammabilityclass | 16 CFR 1610 | Class 1 | Lot 1: Class 1Lot 2: Class 1Lot 3: Class 1 |
| DifferentialPressure(Delta-P)(mm H2O/cm2) | ASTM F2100-19EN14683 :2019+AC (2019)(E),Annex C | < 5.0 mmH20/cm² | Lot 1: Average 3.9mmH2O/cm²Lot 2: Average 3.8mmH2O/cm²Lot 3: Average 4.0mmH2O/cm² |
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WUHAN RAYTEX PROTECTION CO., LTD Sponsor: Subject Device: Surgical face mask,model:Flat type File No.: 510(k) submission report,
510(k) Submission number: K203161
Table 3 - Biocompatibilitv Testing
- 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.
| Test item | Test method | Acceptance Criteria | Result |
|---|---|---|---|
| In Vitro Cytotoxicity | ISO 10993-5: 2009MTT method. | The 50% extract of the testarticle should have at least thesame or a higher viability thanthe 100% extract.Otherwise the test should berepeated. The lower theViab. % value, the higher thecytotoxic potential of the testarticle is. If viability is reducedto <70% of the blank, it has acytotoxic potential.The Viab.% of the 100% extractof the test article is the finalresult. | Under theconditions ofthe test, thetest articlewas found tobe non-cytotoxic |
| Skin Sensitization | ISO 10993-10:2010Guinea PigMaximization | Magnusson and Kligmangrades of 1 or greater in thetest group generally indicatesensitization, providedgrades of less than 1 areseen in control animals. Ifgrades of 1 or greater arenoted in control animals, thenthe reactions of test animalswhich exceed the mostsevere reaction in controlanimals are presumed to bedue to sensitization. If the | Under theconditions ofthe test, thetest articlewas found tobe non-sensitizing |
| 510(k) Submission number: K203161 | response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | ||
| Skin Irritation | ISO 10993-10:2010Skin Irritation Test | Use only (24±2) h, (48±2) h and (72±2) h observations for calculation. After the 72 h grading, all erythema grades plus oedema grades (24±2)h, (48±2) h and (72±2) h were totalled separately for each test article and blank for each animal. The primary irritation score for an animal was calculated by dividing the sum of all the scores by 6 (two test/observation sites, three time points). To obtain the primary irritation index for the test article, add all the primary irritation scores of the individual animals and divide by the number of animals. When blank or negative control was used, calculate the primary irritation score for the controls and subtract that score from the score using the test material to obtain the primary irritation score. | Under the conditions of the test, the test article was found to be non-irritating |
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WUHAN RAYTEX PROTECTION CO., LTD Sponsor:
Subject Device: Surgical face mask,model:Flat type
510(k) submission report, File No.:
510(k) Submission number: K203161
7. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203161, the surgical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202061.
§ 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.