(218 days)
The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is 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 as sterile.
The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). 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. This device is not made from any natural rubber latex.
The provided text describes the acceptance criteria and the study proving the device meets these criteria for a Surgical Face Mask. It is important to note that this is a medical device, not an AI/Software as a Medical Device (SaMD), so the questions related to AI performance, such as MRMC studies, training sets, and expert adjudication, are not applicable in this context. The document focuses on physical, biological, and sterilization performance of the mask.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance data are primarily found in section 7.2 Physical performance testing and the Biocompatibility section within the comparison table.
| Performance Test | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F 1862-17) @ 120 mmHg | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg (Statistics of three lots) | Pass |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | 99.6%-99.8% (Statistics of three lots) | Pass |
| Differential Pressure (Delta-P) (EN 14683: 2019) | < 6.0 mmH₂O/cm² | 4.14-5.90 mmH₂O/cm² (Statistics of three lots) | Pass |
| Particulate Filtration Efficiency (ASTM F2299-2007) | ≥ 98% | 99.69% - 99.98% (Statistics of three lots) | Pass |
| Flammability (16 CFR Part 1610) | Class I | Class I (Statistics of three lots) | Pass |
| Cytotoxicity (ISO 10993-1) | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin Sensitization (ISO 10993-1) | Non-sensitizing | Non-sensitizing | Pass |
| Skin Irritation (ISO 10993-1) | Non-irritating | Non-irritating | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Fluid Resistance Test: 32 samples (indicated by "32 out of 32 pass"). For other physical performance tests, the results are noted as "Statistics of three lots," but specific sample sizes are not explicitly stated for each test (e.g., how many masks constitute a "lot" for testing).
- Data Provenance: The tests were performed on the "proposed device" by the manufacturer, RFX+CARE Manufacturing Co., Ltd., which is based in Shaoxing, Zhejiang, People's Republic of China. The testing appears to be prospective as it was conducted specifically to support this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This submission is for a physical medical device (surgical face mask), not an AI/software device that requires expert adjudication for ground truth. The ground truth for performance is established through standardized laboratory testing (e.g., ASTM, EN standards).
4. Adjudication Method for the Test Set
- Not applicable. See point 3. Testing is conducted according to established methodologies in laboratory settings, not through human adjudication of data.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
- No. This is not an AI-assisted device. The comparison is made against a legally marketed predicate device (K182515) based on technical characteristics and performance standards. Human clinical studies are explicitly stated as not included in this submission (Section 7.4).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical product, not an algorithm.
7. The Type of Ground Truth Used
- The ground truth is established by validated laboratory test methods and established international and national standards (e.g., ASTM F2100-19, ASTM F1862-17, ASTM F2101-19, ASTM F2299-2007, EN 14683: 2019, 16 CFR Part 1610, ISO 10993-1, ISO 11135:2014, ISO 11737-1:2018, ISO 10993-7:2008). These standards define the acceptable performance parameters for surgical face masks and biocompatibility.
8. The Sample Size for the Training Set
- Not applicable. This refers to machine learning models, which are not relevant to this device.
9. How the Ground Truth for the Training Set Was Established
- Not applicable. See point 8.
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June 2, 2021
RFX+CARE Manufacturing Co., Ltd. % James Tsai Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K203190
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 27, 2020 Received: October 27, 2020
Dear James Tsai:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809 ); 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.
Ryan Ortega, PhD Acting 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) K203190
Device Name Surgical Face Mask
Indications for Use (Describe)
The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is 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 as sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Administrative Information
| Date of Summary prepared | April 23, 2021 |
|---|---|
| Manufacturer information | Company: RFX+CARE Manufacturing Co., Ltd.Company address:No. 7 Lanjiang Road, Yuecheng District, Shaoxing,Zhejiang, People's Republic of ChinaContact person: Zhou XiufengPhone: +86-13575509137E-mail: xiufeng.zhou@rfx-care.com |
| Submission Correspondent | Shenzhen Joyantech Consulting Co., Ltd.Address: 1713A, 17th Floor, Block A, ZhongguanTimes Square, Nanshan District, ShenzhenContact person: James TsaiE-Mail: james.tsai@cefda.com; field@cefda.com |
2. Device Information
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Surgical face mask |
| Common name: | Surgical face mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
3. Predicate Device Information
| Sponsor: | Wuhan Dymex Healthcare Co., Ltd. |
|---|---|
| Trade name: | Surgical face mask |
| Common name: | Surgical face mask |
| Classification name: | Surgical Face Mask, Apparel |
| Review Panel: | General and plastic surgery devices |
| Product Code: | FXX |
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ll Device Class: 510(K) Number: K182515 Production regulation: | 21 CFR §878.4040
4. Device Descriptions
The surgical face mask is provided as sterile, single use, 3 lavers, flat-pleated style with ear loops and nose-piece. The outer layer and inner layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt-blown fabric (polypropylene). 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. This device is not made from any natural rubber latex.
5. Indications for Use
The surgical face mask is intended to be worn to protect both patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials. This face mask is 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 as sterile.
| Comparisonitem | Proposed Device | Predicate Device | Remark |
|---|---|---|---|
| Manufacturer | RFX+CAREManufacturing Co., Ltd. | Wuhan Dymex HealthcareCo., Ltd. | / |
| 510k number | K203190 | K182515 | / |
| Product name | Surgical face mask | Surgical face mask | Same |
| Product Code | FXX | FXX | Same |
| Classification | Class II (21 CFR 878.4040) | Class II (21 CFR 878.4040) | Same |
| Intendeduse &Indications forUse | The surgical face mask isintended to be worn toprotect both patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerials. This face mask isintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis a single use, disposabledevice, provided as sterile. | The Surgical Face Masksare intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These face masksare intended for use ininfection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | Same |
| Model andfeatures | D20108Ear Loops, Flat Pleated, 3layers | Ear Loops, Flat Pleated, 3layers | Same |
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Melt-blown fabric(polypropylene) | Melt blown polypropylene | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Polyethylene | Malleable polyethylene wire | Different |
| Ear loops | Polyester & polyurethanefilament | Spandex | Different |
| Color | Blue | Yellow | Different |
| Dimension | Mask body: 17.5cm*9.5cmNose-piece: 8cm-15cmEar loop: 16.5cm-18cm | Mask body: 17.5cm*9.5cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Sterile | Non-sterile | Different |
| Sterilizationmethod andS.A.L. | Sterilized by ethyleneoxide gas, SAL=10-6 | Not applied | Different |
| Use | Single-use, disposable | Single-use, disposable | Same |
| ASTM F2100level | Level 2 | Level 2 | Same |
| FluidResistancePerformance | 32 out of 32 pass at 120mmHg(ASTM F1862) | 32 out of 32 pass at 120mmHg | Same |
| ParticulateFiltrationEfficiency | Pass at 99.69% -99.98%(ASTM F2299) | Pass at 99.7% | Similar |
| BacterialFiltrationEfficiency | Pass at 99.6%-99.8%(ASTM F2101) | Pass at 99.9% | Similar |
| DifferentialPressure(Delta-P) | Pass at 4.14-5.90mmH2O/cm²(EN 14683) | Pass at 4.0 mmH₂O/cm² | Similar |
| Flammability16CFR 1610 | Class I(16 CFR Part 1610) | Class I | Same |
| Biocompatibility | Conform with ISO10993-1;Non-cytotoxic, Non-sensitizing, Non-irritating | Conform with ISO10993-1;Non-cytotoxic, Non-sensitizing, Non-irritating | Same |
| Item | Proposed device | Result | |
| Cytotoxicity | Under the conditions of the study, the device is non-cytotoxic. | Pass | |
| SkinSensitization | Under the conditions of the study, the device is non-sensitizing. | Pass | |
| Skin Irritation | Under the conditions of the study, the device is non-irritating. | Pass |
6. Summary of Technological Characteristics
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From the comparison table and the gap analysis above, the differences in the materials, colors and sterility status will not raise additional issue for safety and
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effectiveness. Physical performance tests and biocompatibility evaluation have been carried out on the finished devices which include all construction materials and color additives; EO sterilization validation has also been provided to prove the product sterility and performance.
7. Non-clinical Test performed on the proposed device
The following performance data of surgical face mask were provided in support of the substantial equivalence determination:
7.1 Biocompatibility testing
The biocompatibility evaluation for the surgical face mask was conducted in accordance with the International Standard ISO 10993-1: 2018 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process," as recognized by FDA. The outer layer, inner layer and ear loops are considered to be contacted with patient's intact face skin for duration of less than 24 hours. And the biocompatibility evaluation included the following tests:
- · Cytotoxicity
- · Skin Sensitization
- · Skin Irritation
7.2 Physical performance testing
Physical performance was conducted, and the results show that the proposed device complies with the following standards:
- · ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
| Item | Subject device | Acceptance criteria | Result |
|---|---|---|---|
| Fluid ResistancePerformance (mmHg)(ASTM F 1862-17) | 32 out of 32 pass at 120 mmHg(Statistics of three lots) | 29 out of 32 pass at120 mmHg | Pass |
| Bacterial FiltrationEfficiencyPerformance (%)(ASTM F2101-19) | 99.6%-99.8%(Statistics of three lots) | ≥ 98% | Pass |
| Differential Pressure | 4.14-5.90 mmH2O/cm² | < 6.0mmH2O/cm² | Pass |
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| (Delta-P)(mm H2O/cm2)(EN 14683: 2019) | (Statistics of three lots) | ||
|---|---|---|---|
| Particulate FiltrationEfficiencyPerformance (%)(ASTM F2299-2007) | 99.69% -99.98%(Statistics of three lots) | ≥ 98% | Pass |
| Flammability(16 CFR Part 1610) | Class I(Statistics of three lots) | Class I | Pass |
7.3 Ethylene oxide Sterilization Validation
The proposed device is also provided for sterilization validation is performed and the results show that the proposed device complies with the following standards:
- · ISO 11135:2014 Sterilization of health-care products Ethylene oxide -Requirements for the development, validation and routine control of a sterilization process for medical devices [Including: Amendment 1 (2018)]
- · ISO 11737-1:2018 Sterilization of health care products Microbiological methods - Part 1: Determination of a population of microorganisms on product
- · ISO 10993-7:2008 Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals
7.4 Clinical Test Conclusion
No clinical study is included in this submission.
8. Conclusions
The conclusion drawn from the non clinical tests demonstrates that the subject device in 510(K) submission K203190 for the Surgical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.
§ 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.