(119 days)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The document provided is a 510(k) summary for a Disposable Surgical Mask, outlining its substantial equivalence to a legally marketed predicate device. As such, the information contained focuses on the device's physical properties, material composition, and performance against established safety and efficacy standards for surgical masks.
This type of submission and the associated testing do not involve AI/ML components, human reader studies, or complex ground truth establishment methods typical for AI/ML-driven medical devices. The tests described are laboratory-based evaluations of the mask's material properties and fluid/particulate blocking capabilities.
Therefore, many of the specific questions posed in your request (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this disposable surgical mask submission.
Here's the relevant information based on the provided text:
Acceptance Criteria and Device Performance
The acceptance criteria are established based on recognized industrial standards for performance of materials used in medical face masks.
Table of Acceptance Criteria and Reported Device Performance
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance Performance (ASTM F1862) | For evaluating the ability of the mask's material to resist the penetration of blood and body fluids. | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (ASTM F2299) | For evaluating a submicron efficiency performance. | > 98% | > 98% |
| Bacterial Filtration Efficiency (ASTM F2101) | For evaluating the ability of the mask's material to prevent the passage of aerosolized bacteria. | > 98% | > 98% |
| Differential Pressure (EN 14683:2019) | For evaluating the breathability and comfort of the surgical mask. | < 6.0mmH2O/cm² | < 6.0mmH2O/cm² |
| Flammability (16 CFR 1610) | For evaluating the flammability of the material. | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | For evaluating the cytotoxicity of the materials. | Non-cytotoxicity | Non-cytotoxicity effect |
| Irritation (ISO 10993-10) | For evaluating the skin irritation of the materials. | Non-irritation | Non-irritation |
| Sensitization (ISO 10993-10) | For evaluating the sensitization of the materials. | Non-sensitization | Non-sensitization |
Study Details
-
Sample size used for the test set and the data provenance:
The document does not specify the exact sample sizes (number of masks or material samples) used for each test. The tests are laboratory-based, performed on material samples of the mask. Data provenance is implied to be from the manufacturer's internal testing. There is no indication of patient data or clinical data; the study is entirely non-clinical. The origin of the testing would be where the manufacturer is located, which is Dongguan, China. The studies are retrospective laboratory tests on manufactured samples. -
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth for these performance tests is established by adhering to widely accepted international standards (e.g., ASTM, EN, ISO) and their specified testing methodologies and acceptance criteria. There are no "experts" in the human perception or diagnostic sense involved in establishing ground truth for these physical properties. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This concept pertains to expert review of data (e.g., medical images). The "ground truth" for these tests is the quantitative measurement of physical properties against a standard. -
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:
Not applicable. This is a simple medical device (disposable surgical mask), not an AI-assisted diagnostic tool. No human reader studies were performed. -
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm or AI component in this device. The "standalone performance" refers to the mask's inherent physical characteristics as tested in the laboratory. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The ground truth is defined by the acceptance criteria established by standardized, validated test methods (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency), which are internationally recognized and specified in the FDA's guidance document for surgical masks. These are objective, measurable physical properties, not subjective interpretations or clinical outcomes. -
The sample size for the training set:
Not applicable. This device does not involve machine learning; therefore, there is no "training set." -
How the ground truth for the training set was established:
Not applicable, as there is no training set.
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June 7, 2021
Dongguan Shin Yi Healthcare Products Factory % Joyce Yang Consultant Shenzhen Jovantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 51800 China
Re: K210372
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX, Dated: April 25, 2021 Received: May 3, 2021
Dear Joyce Yang:
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 (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 -S
Clarence W. Murray, III, 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210372
Device Name Disposable Surgical Mask
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
| 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
510(k) Number: K210372
Date Prepared: June 5, 2021
1.Submission Sponsor
| Manufacturer information | Company: Dongguan Shin Yi HealthcareProducts Factory |
|---|---|
| Company address: No. 17 Ban Hu Road, HuangJiang Town, Dong Guan City, Guang DongProvince, China. | |
| Contact person: Zhao Shuge | |
| Phone: +86-769-83361381 | |
| Fax: +86-769-83631102 | |
| E-mail: zhaosg.dg@master-frank.cn |
2. Submission correspondent
| Name Address | Shenzhen Joyantech Consulting Co., Ltd1713A, 17th Floor, Block A, Zhongguan Times Square,Nanshan District, Shenzhen |
|---|---|
| Post Code Phone No. | 51800086-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Surgical Mask |
| Model: | MFA05004, MFA05005, MFA05007, MFA05008 |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 21 CFR 878.4040 |
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4. Legally Marketed Predicate Device
| Trade Name | Single-use Surgical Mask |
|---|---|
| Regulation number | 21 CFR 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K200923 |
| Product Code | FXX |
| Manufacturer | BYD Precision Manufacturer Co.,Ltd. |
5. Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Surgical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four ties welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of Malleable aluminum wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
6. Intended Use/ Indications for Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These masks are 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.
7. Technological characteristics comparison
| Comparisonitem | Subject Device: DisposableSurgical Mask(K210372) | Predicate Device: Single-use Surgical Mask(K200923) | Comments |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended use & | The Surgical Masks are | The Single-use Surgical | Same |
| Comparisonitem | Subject Device: DisposableSurgical Mask(K210372) | Predicate Device: Single-use Surgical Mask(K200923) | Comments |
| Indications for Use | intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. These masks areintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. This isa single use ,disposabledevice, provided non-sterile. | Face Masks are intendedto be worn to protect boththe patient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemasks are intended foruse in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a singleuse, disposable device,provided non-sterile. | |
| Designfeature | Ear-loop, Tie-on | Ear-loop | Similar(Issue 1) |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | $(18±1)cm×(9±1)cm$$(14.5±1)cm×(9±1)cm$ | $(17.5±1)cm×(9.5±1)cm$ | Similar(Issue 2) |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: Spun-bondpolypropylene | Outer layer: Spun-bondpolypropylene | Same |
| Middle layer: Melt blownpolypropylene filter | Middle layer: Melt blownpolypropylene filter | Same | |
| Inner layer: Spun-bondpolypropylene | Inner layer:Spun-bondpolypropylene | Same | |
| Nose piece:Malleablealuminum wire | Nose piece:Metal CorePlastic | Different(Issue 3) | |
| Comparisonitem | Subject Device: DisposableSurgical Mask(K210372) | Predicate Device: Single-use Surgical Mask(K200923) | Comments |
| Ear-loops: Elastic fiberTie-on:Spun-bondpolypropylene | Ear-loops: Polyester | Similar(Issue 3) | |
| ASTM F2100 Level | Level 3 | Level 3 | Same |
| FluidResistancePerformanceASTM F1862-13 | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| ParticulateFiltrationEfficiencyASTM F2299 | > 98% | > 98% | Same |
| BacterialFiltrationEfficiencyASTM F2101 | > 98% | > 98% | Same |
| DifferentialPressure(Delta P) EN14683:2019+AC : 2019 | < 6.0mmH2O/cm² | < 6.0mmH2O/cm² | Same |
| Flammability16CFR 1610 | 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 |
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Issue 1: Compared to the predicate device, the subject device has an additional design feature "Tie-on". The difference in design feature do not affect the performance of the face mask.
Issue 2: The sizes of proposed device are a little smaller than the size of predicate device. The small size is to apply to the population with thin face, and there is no difference in performance.
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lssue 3: The nose piece is used to allow the user to fit the face mask around their nose. The difference of materials of nose piece between subject device and predicate device could not affect the performance of the face mask.
The Ear-loops of the proposed device are made by elastic fiber, which of the predicate device is made by polyester. The major chemical composition of the elastic fiber is segmented polyurethane-urea, which is similar to polyester.
In addition, the proposed devices have been tested for biocompatibility, and the test results confirm that the device is biocompatible.
8. Summary of Non-clinical Testing
Non-clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards:
- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
- ANSI/AAMI/ISO 11135:2014 Sterilization of health care products Ethylene ● oxide - Requirements for Development, validation, and routine control of a sterilization process for Medical devices
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices Part 5: Tests ● For In Vitro Cytotoxicity.
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Fluid ResistancePerformance(ASTM F1862) | For evaluating the ability ofthe mask's material to resistthe penetration of blood andbody fluids. | Pass at 160 mmHg | Pass at 160mmHg |
Table 2: Performance Characteristic
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| Test Methodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| Particulate FiltrationEfficiency( ASTM F2299 ) | For evaluating a submicronefficiency performance | > 98% | > 98% |
| Bacterial FiltrationEfficiency(ASTM F2101) | For evaluating the ability ofthe mask's material toprevent the passage ofaerosolized bacteria | > 98% | > 98% |
| Differential Pressure(EN 14683:2019) | For evaluating thebreathability and comfort ofthe surgical mask | < 6.0mmH2O/cm² | < 6.0mmH2O/cm² |
| Flammability (16CFR 1610) | For evaluating theflammability of the material | Class 1 | Class 1 |
Table 3: Biocompatibility
| TestMethodology | Purpose | AcceptanceCriteria | Results |
|---|---|---|---|
| Cytotoxicity | For evaluating the cytotoxicityof the materials | Non-cytotoxicity | Under the conditionsof the study, non-cytotoxicity effect |
| Irritation | For evaluating the skin irritationof the materials | Non-irritation | Under the conditions ofthe study, non-irritation |
| Sensitization | For evaluating the sensitizationof the materials | Non-sensitization | Under the conditions ofthe study, non-sensitization |
9. Brief discussion of clinical tests
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission K210372, the Disposable Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K200923.
§ 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.