(157 days)
The Medical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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. Face Masks are single use, disposable device, provided non-sterile.
The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (PTFE membrane filter) and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nosepiece (iron wire with white plastic covering) to provide a firm fit over the nose.
The provided text is a 510(k) summary for a Medical Face Mask (K202493). This document details the device's characteristics, its comparison to a predicate device, and the results of non-clinical performance tests.
Here's an analysis of the acceptance criteria and study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The relevant information is presented under "Table 1 Summary of Performance Test" in the document.
| Performance Characteristics | Acceptance Criteria | Test Result |
|---|---|---|
| Bacterial Filtration Efficiency Performance (%) | ≥98% | 99.9% |
| Differential Pressure (Delta-P) (mm H2O/cm²) | <6.0 | 4.01 |
| Particulate Filtration Efficiency at 0.1micron Performance (%) | ≥98% | 99.1% |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results | 160 | 160 |
| Flammability Class | Class 1 | Class 1 |
| Cytotoxicity | If viability is reduced to <70% of the blank, it has a cytotoxic potential. | Non-cytotoxic |
| Irritation | Primary irritation index: (0-0.4) negligible; (0.5-1.9) slight; (2-4.9) moderate; (5-8) severe | Non-sensitizing |
| Sensitization | Magnusson and Kingman grades of 1 or greater in the test group generally indicate (sensitization) | Non-irritating |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not explicitly state the sample size for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). However, for the Fluid Resistance test, it mentions "32/32 passed at 160 mmHg", which implies a sample size of 32 for that specific test. The document focuses on demonstrating substantial equivalence through non-clinical testing against established standards, rather than new clinical trials with patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document. The tests performed are laboratory-based and follow established international standards (ASTM, MIL-M, ISO, 16 CFR). These standards define the methodology and acceptance criteria, and their execution would typically be undertaken by trained laboratory technicians or scientists, rather than by medical experts establishing "ground truth" in the clinical sense.
4. Adjudication Method for the Test Set
This information is not applicable and therefore not provided. "Adjudication method" usually refers to a process of resolving disagreements among experts when establishing ground truth for a test set, typically in a clinical or image-interpretation context. The tests described are objective, standardized laboratory tests with clear pass/fail criteria.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI systems on human performance in diagnostic tasks, which is not the purpose of this submission (which concerns a medical face mask).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, a standalone (algorithm only) performance study was not done. This type of study is specifically for AI/software devices. The device in question is a physical medical face mask, and its performance is evaluated through physical and material tests, not algorithm performance.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests performed on the Medical Face Mask is based on objective, quantitative measurements in accordance with established international testing standards. For example:
- Bacterial Filtration Efficiency (BFE): Measured objectively as a percentage according to ASTM F2101.
- Differential Pressure: Measured objectively in mmH2O/cm² according to MIL-M-36954C.
- Particulate Filtration Efficiency (PFE): Measured objectively as a percentage according to ASTM F2299.
- Fluid Resistance: Measured objectively by resistance to synthetic blood penetration at a specific pressure (160 mmHg) according to ASTM F1862.
- Flammability: Objectively classified according to 16 CFR Part 1610.
- Biocompatibility (Cytotoxicity, Irritation, Sensitization): Evaluated through standardized biological assays with defined endpoints (e.g., cell viability for cytotoxicity, irritation index for irritation), as per ISO 10993 series.
There is no "expert consensus," "pathology," or "outcomes data" ground truth in the traditional sense for these types of physical product performance tests.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. "Training set" refers to data used to train AI algorithms. The Medical Face Mask is a physical medical device, not an AI or software device, so there is no training set in this context.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and therefore not provided, for the reasons mentioned in point 8.
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February 4, 2021
Gemtier Medical (Shanghai) Inc % Julie Chen Technical Manager Shanghai Medical Business Consulting Co., Ltd. No. 170 Huajiang Road, Jiading District Shanghai, 201803 China
Re: K202493
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 24, 2020 Received: January 6, 2021
Dear Julie Chen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Elizabeth Claverie, M.S. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Medical Face Mask
Indications for Use (Describe)
The Medical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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. Face Masks are single use, disposable device, provided non-sterile.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary -K202493
I. SUBMITTER:
Gemtier Medical (Shanghai) Inc. No.18 Jianding road, Fengjing town, Jinshan district, Shanghai, China, 201502
Contact Person: Li zhi qing Title: RA Director Phone: (+86) 189 1703 5908 Email: lizhiqing@jintayiqi.com
Submission Correspondent: Julie Chen Email: julie.chen(@medicalbc.net Tel:+86 139 1804 5781
Summary prepared: 08/24/2020
II. DEVICE
Name of Device: Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX
PREDICATE DEVICE III.
Primary predicate device: DemeMask (K201479)
IV. DEVICE DESCRIPTION
The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer,
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between the outer layer and inner layers (PTFE membrane filter) and an inner layer polypropylene). Each mask contains tie strings (spun-bond (spun-bond polypropylene) or ear loops (Spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nosepiece (iron wire with white plastic covering) to provide a firm fit over the nose.
| REF No. | Product Size | Model Description | ||
|---|---|---|---|---|
| Mask | Ear Loop | Tie-on | ||
| NS2R-D2 | 17.5cm×9.5cm | X | X | |
| NS2R-02 | 17cm×9.5cm | X | X | |
| NS2R-C2 | 14.5cm×9.5cm | X | X | |
| NS2R-I2 | 17.5cm×9.5cm | X | X | |
| NS2R-E2 | 17cm×9.5cm | X | X | |
| NS2R-H2 | 14.5cm×9cm | X | X |
- V. Available Model
VI. INDICATIONS FOR USE
The Medical Face Masks are 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. The Medical Face Masks are single use, disposable device, provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE
The Medical Face Masks are compared with the predicate device (DemeMask K201479). The results are shown below in the Technological Characteristics Comparison Table:
| DEVICE | Subject Device | Primary Predicate Device | SubstantialEquivalence | |
|---|---|---|---|---|
| Intended Use | Medical Face Mask(K202493) | DemeMask (K201479) | Same | |
| The Medical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material. These | The Disposable Surgical FaceMasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. | |||
| face masks are intended for use These face masks are intended | ||||
| in infection control practices to for use in infection control | ||||
| reduce the potential exposure to practices to reduce the potential | ||||
| exposure to blood and body | ||||
| Medical Face Masks are single | ||||
| fluids. This is a single use, | ||||
| use, disposable device, | ||||
| disposable device provided | ||||
| provided non-sterile. | ||||
| nonsterile. | ||||
| Classification | FXX | FXX | Same | |
| Product Code | ||||
| Ear Loop Modeland Tie-onModel | Ear Loops, Tie-On | Ear Loops | Similar | |
| Materials | ||||
| OuterLayer | Facing | Spun-bond Polypropylene | Spun-bond polypropylene | Similar |
| Middle Layer | Filter layer | Polytetrafluoroethylene (PTFEMembrane)InsertionLayer | Meltblown polypropylenefilter | Similar |
| PP SPUNBONDNON-WOVENFABRIC, white | ||||
| InnerLayer | Facing | Spun-bond Polypropylene | Spun-bond polypropylene | Similar |
| Nose Piece | Malleable iron wire with plasticcovering | Galvanized wire coated withpolyethylene | Similar | |
| Tie Strings | Spun-bond Polypropylene | Spun-bond polypropylene | Similar | |
| Ear Loops | Spandex elastic cord | Spandex and Nylon | Similar | |
| Design Features | ||||
| Color | Blue | Blue | Same | |
| Style | Flat - Pleated | Flat - Pleated | Same | |
| Multiple Layers | 3 Layers | 3 Layers | Same | |
| Single Use | Single use | Single use | Same | |
| Sterile | SterilityNon-sterile | Non-sterile | Same | |
| Dimensions | ||||
| Length × Width | 175×95mm (±5%)170×95mm (±5%)145×95mm (±5%) | Length: 17.5 cm±1 cm | ||
| Width: 9.5 cm±1 cm | Similar | |||
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 - | ||||
| Fluid Resistance | Meets Level 332/32 passed at 160 mmHg | 32/32 passed at 160 mmHg | Same | |
| ASTM F1862 | ||||
| ParticulateFiltrationEfficiency (PFE)ASTM F2299 | Pass at 99.1% | Pass at ≥99% | Same | |
| Bacterial FiltrationEfficiency (BFE)ASTM F2101 | Pass at 99.9% | Pass at ≥99% | Same | |
| DifferentialPressure (Delta P)MIL-M-36954C | Average 4.01 mmH2O/cm² | Average 3.6 mmH2O/cm² | Same | |
| Flammability16 CFR PART1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Same | |
| Biocompatibility | ||||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same | |
| Irritation | Non-sensitizing | Non-sensitizing | Same | |
| Sensitization | Non-irritating | Non-irritating | Same |
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VIII. PERFORMANCE DATA
Non-Clinical Performance Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Medical Face Mask complies with the following standards:
- . ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to ● Penetration by
- Synthetic Blood (Horizontal Projection of Fixed Volume at a Known ● Velocity)
- ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2101 Standard Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
- MIL-M- 36954C Military Specification, Mask, Surgical, Disposable ●
- 16 CFR Part 1610 Standard for the Flammability of Clothing
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- ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process
- ISO10993-5 Biological evaluation of medical devices Part 5: Tests for in . vitro cytotoxicity of medical devices
- . ISO10993-10 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
Clinical Test Conclusion
No clinical study is included in this submission.
| PerformanceCharacteristics | Methodology | Purpose | AcceptanceCriteria | Test Result |
|---|---|---|---|---|
| Bacterial FiltrationEfficiencyPerformance(%) | ASTM F2101 | This performance test aimsto verify Bacterial FiltrationEfficiency (BFE) of theMedical face mask reacheslevel 3 as required in ASTMF 2100:2019 | ≥98 | 99.9% |
| Differential Pressure(Delta-P)(mm H2O/cm²) | MIL-M-36954C | This performance test aimsto verify the breathingresistance of Medical facemask reaches level 3 asrequired in ASTM F2100:2019 | <6.0 | 4.01 |
| Particulate FiltrationEfficiencyat 0.1micronPerformance (%) | ASTM F2299 | This performance test aimsto verify the ParticulateFiltration Efficiency ofMedical face mask reacheslevel 3 as required in ASTMF 2100:2019 | ≥98 | 99.1% |
| Resistance topenetration bysynthetic blood,Minimumpressure in mmHg forpass results | ASTM F1862 | To verify the fluid resistanceof the Medical face maskreaches level 3 as required inASTM F 2100:2019,through perform the fluidresistance testing. | 160 | 160 |
| Flammability Class | 16 CFR PART 1610 | To verify the flammabilityof the Medical face mask | Class 1 | Class 1 |
| Cytotoxicity | ISO 10993-5:2009 | reaches level 3 as required inASTM F 2100:2019,through conduct theflammability testingThe purpose of the test is todetermine the biologicalreactivity of mammalian cellculture (mouse fibroblastL929 cells) in response tothe test article | If viability isreduced to<70% ofthe blank, ithas acytotoxicpotential. | Non-cytotoxic |
| Irritation | ISO 10993-10: 2010 | The test was designed toevaluate the potential of atest article cause skinirritation | Use only24±2h,48±2h and72±2hobservationforcalculation.The primaryirritationindex forthe testarticle wasevaluatedaccording toas follows:(0-0.4)negligible;(0.5-1.9)slight;(2-4.9)moderate;(5-8)severe | Non-sensitizing |
| Sensitization | ISO 10993-10: 2010 | The test was designed toevaluate the potential of atest article cause skinsensitization | MagnussonandKingmangrades of 1or greater inthe testgroupgenerallyindicate | Non-irritating |
Table 1 Summary of Performance Test
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IX. 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 DemeMask (K201479).
§ 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.