(294 days)
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 non-sterile.
Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.
Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
This document is a 510(k) summary for a Disposable Medical Mask (Model: k0450). It focuses on demonstrating substantial equivalence to a predicate device. The information provided is for a medical device (surgical mask), not a software or AI device. Therefore, the concepts of human readers, AI assistance, effect size, training sets, and ground truth establishment in the context of AI/ML models are not applicable to this document.
The acceptance criteria and performance data pertain to the physical characteristics and barrier performance of the surgical mask.
1. Table of acceptance criteria and the reported device performance
| Test Purpose | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (mmHg) | ASTM F1862 | ≥ 29 Out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration Efficiency Performance (%) | ASTM F2299 | ≥ 98% | 99.9% |
| Bacterial Filtration Efficiency Performance (%) | ASTM F2101 | ≥ 98% | 99.9% |
| Flammability class | 16 CFR 1610 | Class 1 | Class 1 |
| Differential Pressure (Delta-P) (mm H2O/cm2) | ASTM F2100-19 | < 5.0 mmH2O/cm2 | < 5.0 mmH2O/cm2 |
2. Sample size used for the test set and the data provenance
- Fluid Resistance Performance (ASTM F1862): The test involved 32 samples as indicated by the acceptance criteria and reported performance ("29 Out of 32 pass" and "32 out of 32 pass").
- Other tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Flammability, Differential Pressure): The sample sizes for these specific tests are not explicitly stated in the provided text, beyond the percentage or class reported.
- Data Provenance: The tests were conducted by a lab (implied by "lab bench testing") to evaluate the safety and effectiveness of the device. The specific country of origin of the testing lab is not mentioned, though the manufacturer is based in China. The tests are described as "non-clinical tests" and not related to human subject data, therefore, "retrospective or prospective" doesn't apply in the context of clinical trials.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
N/A. This is a physical medical device (surgical mask) evaluated by laboratory bench testing against established performance standards. "Experts" to establish a ground truth in the sense of clinical interpretation or diagnosis are not relevant for this type of testing. The "ground truth" is defined by the objective measurement standards referenced (e.g., ASTM F1862, ASTM F2101).
4. Adjudication method for the test set
N/A. As this involves objective physical testing against defined standards, an adjudication method for reconciling expert opinions is not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
N/A. An MRMC study is relevant for comparing the performance of readers (e.g., clinicians) with and without assistance from a diagnostic tool or AI. This submission is for a physical medical device (surgical mask) and does not involve human readers in its performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
N/A. This is not a software or algorithm-based medical device.
7. The type of ground truth used
The "ground truth" for the performance of the Disposable Medical Mask is based on objective measurements against established performance standards (e.g., ASTM F1862 for fluid resistance, ASTM F2101 for bacterial filtration efficiency, 16 CFR 1610 for flammability). These standards define the criteria for a "Level 2 barrier" mask.
8. The sample size for the training set
N/A. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
N/A. This is not an AI/ML device that requires a training set or ground truth established for it.
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September 13, 2021
Fujian Kang Chen Daily Necessities CO., LTD Shuyan Wang Administrative Director No.55 Houdun Road, houmao Industrial Zone, Fengze District Quanzhou, Fujian 362000 China
Re: K203455
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 5, 2021 Received: August 9, 2021
Dear Shuyan Wang:
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.
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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K203455
Device Name Disposable Medical mask
Indications for Use (Describe)
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 non-sterile.
Model: k0450, blue color, and Level 2 barrier level per ASTM F2100.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510k Summary
Prepared Date:09/13/2021
510k Number: 203455
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter Information
Sponsor : FUJIAN KANG CHEN DAILY NECESSITIES CO.,LTD
Address: No.55 Houdun Road, houmao Industrial Zone, Fengze District, Quanzhou
City, Fujian Province, China.
Contact Person: Shuyan Wang (Administrative Director)
Phone: +86-595-28892058
Fax:+86- 595-28892058
E-mail: shuyan@consoncompanies.com
2. Subject Device Information
| Type of 510(k): | Traditional |
|---|---|
| Common Name: | Surgical mask |
| Trade Name: | Disposable Medical Mask |
| Model: | k0450 |
| Classification Name: | Surgical Apparel |
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
3. Predicate Device Information
| Sponsor: | Qiqihar Hengxin Medical Supplies,Ltd. |
|---|---|
| Common Name: | Surgical Mask |
| Trade Name: | Single-Use Surgical Face Mask with Ear Loop |
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| 510(k) number: | K201691 |
|---|---|
| Model: | L |
| Classification Name: | Surgical Apparel |
|---|---|
| Review Panel: | General Hospital |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Regulation Class: | II |
4. Indications for Use
The Disposable Medical mask is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The Disposable Medical mask intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, disposable device, provided non-sterile.
Model: k0450, blue color, and Level 2 barrier level as ASTM F2100.
5. Device Description
Disposable Medical Mask are non-sterile, single use, 3 layers, flat-pleated style with ear loops and nose clip. The outer layer and inner facing layer of face mask consist of Spunbond Polypropylene, and the middle layer consists of Melt Blown Polypropylene Filter. Each mask contains ear loops to secure the mask over the users' mouth and face and includes a nose clip to provide a firm fit over the nose. The mask is a single use, disposable device, provided non-sterile.
6. Test Summary
Surgical face mask has been evaluated the safety and effectiveness by lab bench testing according to the following standards:
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- 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 In Vitro Cytotoxicity
- . ISO 10993-10, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
Summary of Comparison and Technological Characteristics 7.
| Elements ofComparison | Subject Device | Predicate Device | Results | |
|---|---|---|---|---|
| Product Name | Disposable MedicalMask (Model: k0450) | Single-Use SurgicalMask with Ear Loop(Model:L) | -- | |
| 510(k) Number | K203455 | K201691 | ||
| General Comparison | ||||
| Elements ofComparison | Subject Device | Predicate Device | Results | |
| Indication for Use | The DisposableMedical mask isintended to be wornto protect both thepatient andhealthcare personnelfrom the transfer ofmicroorganisms,body fluids andparticulate material.The DisposableMedical mask isintended for use ininfection controlpractices to reducethe potentialexposure to bloodand body fluids.This is a single use,disposable device,provided non-sterile.Model: k0450, bluecolor, and Level 2barrier level as ASTMF2100. | The Single-Use surgicalmask with Ear Loop isintended to be worn toprotect both the patientand healthcarepersonnel from thetransfer ofmicroorganisms, bodyfluids and particulatematerial. The Single-UseMask with Ear Loopintended for use ininfection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile.Model:M and L, bluecolor, and Level 2 barrierlevel as ASTM F2100 | Same | |
| Model | 3 layers, Ear Loops,Flat-Pleated Style | 3 layers, Ear Loops,Flat-Pleated Style | ||
| Material | Outerfacing layer | Spun-bondpolypropylene | Spun-bond non-wovenfabric | DifferentNote 1 |
| Elements ofComparison | Subject Device | Predicate Device | Results | |
| Middlelayer | Melt blownpolypropylene filter | Melt blown non-wovenfabric | DifferentNote 2 | |
| Innerfacing layer | Spun-bondpolypropylene | Spun-bond non-wovenfabric | DifferentNote 3 | |
| Nose clip | aluminum wire coatedby polyethylene. | Malleable aluminumwire | DifferentNote4 | |
| Ear loops | Spandex | Polyester | DifferentNote 5 | |
| Color | Blue | Blue | Same | |
| Dimension (Width) | 9.5cm ± 0.5cm | 9.0cm ± 1.0cm | DifferentNote 6 | |
| Dimension (Length) | 17.5cm ± 0.5cm | 18.0cm ± 1.0cm | ||
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use | Single Use | Same | |
| ASTM F2100 Level | Level2 | Level 2 | Same | |
| Fluid ResistancePerformance (mmHg) | 32 out of 32 pass at 120mmHg | 31 Out of 32 pass at120 mmHg | Similar | |
| Particulate FiltrationEfficiencyPerformance (%) | 99.9% | ≥ 99% | Same | |
| Bacterial FiltrationEfficiencyPerformance (%) | 99.9% | ≥ 99% | Same | |
| Flammability class | Class 1 | Class 1 | Same | |
| Differential Pressure(Delta-P)(mm H2O/cm2) | <5.0 mmH2O/cm2 | < 5.0 mmH20/cm2 | Same |
Table 1 - General Comparison
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Note1: Although their are differences in the material of the outer facing layer, the difference does not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
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Note2: Although their are differences in the material of the middle layer, the difference does not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
Note3: Although their are differences in the material of the inner facing layer, the difference does not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
Note4: Although their are differences in the material of the nose clip, the difference does not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
Note5: Although their are differences in the material of the ear loops, the difference does not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
Note 6: Although their are differences in the dimension that do not raise any issues of safety and effectiveness based on the results obtained in the biocompatibility studies and performance studies.
8. 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.
| Test purpose | Test Method | Pass Criteria | Results |
|---|---|---|---|
| FluidResistancePerformance(mmHg) | ASTMF1862 | 29 Out of 32 pass at120 mmHg | 32 out of 32 pass at 120mmHg |
| ParticulateFiltrationEfficiencyPerformance(%) | ASTMF2299 | ≥ 98% | 99.9% |
| BacterialFiltrationEfficiency | ASTMF2101 | ≥ 98% | 99.9% |
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| Performance(%) | |||
|---|---|---|---|
| Flammability class | 16 CFR 1610 | Class 1 | Class 1 |
| Differential Pressure(Delta-P)(mm H2O/cm2) | ASTM F2100-19 | < 5.0 mmH2O/cm2 | < 5.0 mmH2O/cm2 |
9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K203455, the Disposable Medical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K201691.
§ 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.