(174 days)
The Disposable 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 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 ear loops and nose piece. The Disposable Medical Face 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 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 polypropylene with steel wire. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
The provided document is a 510(k) summary for the Wanxinda (Guangzhou) Technology Product Co., Ltd's Disposable Medical Face Mask. It details the device's characteristics, intended use, and a comparison with a predicate device to demonstrate substantial equivalence.
Here's a breakdown of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100-19 standard for Level 1 classification.
| Performance Metric | Acceptance Criteria (ASTM F2100 Level 1) | Reported Device Performance (Disposable Medical Face Mask) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 80 mmHg | Pass at 80 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | $\geq$ 0.1 microns, $\geq$ 95% | 99.8% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | $\geq$ 3.0 microns, $\geq$ 95% | 99.8% |
| Differential Pressure (EN 14683) | $<\text{5.0 mm H2O/cm}^2$ | $<\text{5.0 mm H2O/cm}^2$ |
| Flammability (16CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic |
| Irritation (ISO 10993-10) | Non-irritating | Non-irritating |
| Sensitization (ISO 10993-10) | Non-sensitizing | Non-sensitizing |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for each specific bench test performed. However, it mentions that the tests were conducted according to the listed standards (ASTM F2100-19, ISO 10993-1, ISO 10993-5, ISO 10993-10). These standards typically specify the number of samples required for testing.
The data provenance is not specified in terms of country of origin but is from non-clinical (bench) testing performed by the manufacturer to support the 510(k) submission. All provided information refers to the manufacturer's own testing for their device. The studies are retrospective as they present results of tests performed.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. This device is a medical face mask, and its performance is evaluated through standardized bench testing (physical, chemical, and biological properties) against established standards rather than through subjective expert assessment of images or clinical outcomes. The "ground truth" for the test set is defined by the requirements of the ASTM and ISO standards themselves.
4. Adjudication Method for the Test Set
Not applicable. As noted above, performance is assessed against objective, quantifiable metrics defined by international standards (ASTM and ISO). There is no "adjudication" in the sense of expert review for consensus; rather, the test results either meet or do not meet the predefined numerical criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI-powered diagnostic devices where human reader performance is a key factor. This document pertains to a physical medical device (face mask) evaluated through bench testing.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This device is not an algorithm or AI system. It is a physical medical device. The "standalone" performance here refers to the device's physical and biological properties as measured by bench tests, without human intervention in its function (beyond wearing it).
7. The Type of Ground Truth Used
The "ground truth" for this device's performance relies on objective, quantifiable measurements derived from recognized international standards and protocols. Specifically:
- Physical performance (fluid resistance, filtration efficiency, differential pressure, flammability) is determined by the results of tests conducted according to ASTM standards (F1862, F2299, F2101, 16CFR 1610) and EN 14683.
- Biocompatibility (cytotoxicity, irritation, sensitization) is determined by the results of tests conducted according to ISO 10993-5 and ISO 10993-10 standards.
8. The Sample Size for the Training Set
Not applicable. The disposable medical face mask is a physical device, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for a physical medical device like a face mask.
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March 9, 2021
Wanxinda (Guangzhou) Technology Product Co., Ltd % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K202710
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2020 Received: September 16, 2020
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 801and Part 809: medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or post-marketing 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 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202710
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable 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 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 nonsterile.
| 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: K202710 Date of summary prepared: March 6, 2021
Submission Sponsor 1.
| Applicant Name | Wanxinda(Guangzhou)Technology Product Co.,Ltd. |
|---|---|
| Address | Ling Xi Road, Accessory Section 2, Automobile Zone, Huadu District, Guangzhou, Guangdong, China. |
| Contact person | Zeng Xueping |
| Phone | 86-020-61816666 |
2. Submission correspondent
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | 86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Medical Face Mask |
| Model: | WXDKZ0001, WXDKZ0006 |
| Classification name: | Mask, Surgical |
| Common name: | Surgical face mask |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
Legally Marketed Predicate Device 4.
| Trade Name | Surgical Face Mask |
|---|---|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K133070 |
| Product Code | FXX |
| Manufacturer | BH Medical Products Co.,Ltd. |
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Device Description 5.
The proposed devices are single use, three-layer, flat masks with ear loops and nose piece. The Disposable Medical Face 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 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 polypropylene with steel wire.
The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
6. Intended Use/ Indications for Use
The Disposable 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 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.
| Comparisonitem | Subject Device(K202710) | Predicate Device(K133070) | Comments |
|---|---|---|---|
| ProductCode | FXX | FXX | Same |
| RegulationNumber | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classification | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intendeduse &Indications for Use | The Disposable MedicalFace Masks are intended tobe worn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, body fluidsand particulate material.These masks are intendedfor use in infection control | The Disposable SurgicalMasks are intended to beworn to protect both thepatient and healthcarepersonnel from transfer ofmicroorganisms, bodyfluids and particulatematerial. These facemask are intended for use | Same |
| Comparisonitem | Subject Device(K202710) | Predicate Device(K133070) | Comments |
| practices to reduce thepotential exposure to bloodand body fluids. This is asingle use ,disposabledevice, provided non-sterile. | in infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a singleuse ,disposable device,provided non-sterile. | ||
| Designfeature | Ear-loop | Ear-loop, Tie-on | SimilarIssue 1 |
| Usage | Single use | Single use | Same |
| Color | White, Blue | Blue, Green | SimilarIssue 2 |
| Size | Width: $175mm \pm 5%$Length: $95mm \pm 5%$ | Width: $6.5" +/-0.25"$Length: $3.5" +/-0.25"$$4.2" +/-0.25"$ | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: polypropylenenon-woven | Outer layer: Spun-bondpolypropylene | Same |
| Middle layer: Melt blownfabric | Middle layer: Melt blownpolypropylene | Same | |
| Inner layer: polypropylenenon-woven | Inner layer:Spun-bondpolypropylene | Same | |
| Nose piece: PP+Steel wire | Nose piece: Aluminumwire | SimilarIssue 3 | |
| Ear-loops: Spandex | Ear-loops:Polyester | SimilarIssue 4 | |
| ASTM F2100 Level | Level 1 | Level 1, Level 2, Level 3 | SimilarIssue 5 |
| FluidResistancePerformanceASTM F1862-13 | Meet the ASTM F2100Requirements for Level 1Classification | Meet the ASTM F2100Requirements for Level 1,Level 2, Level 3Classification | SimilarIssue 5 |
| ParticulateFiltrationEfficiencyASTM F | Meet the ASTM F2100Requirements for Level 1Classification | Meet the ASTM F2100Requirements for Level 1,Level 2, Level 3 | SimilarIssue 5 |
| Comparisonitem | Subject Device(K202710) | Predicate Device(K133070) | Comments |
| 2299 | Classification | ||
| BacterialFiltrationEfficiencyASTM F2101 | Meet the ASTM F2100Requirements for Level 1Classification | Meet the ASTM F2100Requirements for Level 1,Level 2, Level 3Classification | SimilarIssue 5 |
| DifferentialPressure(Delta P) EN14683:2019+AC : 2019 | Meet the ASTM F2100Requirements for Level 1Classification | Meet the ASTM F2100Requirements for Level 1,Level 2, Level 3Classification | SimilarIssue 5 |
| 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 10993-10 Non irritating | Same |
| Sensitization | Comply with ISO 10993-10Non sensitizing | Comply with ISO 10993-10 Non sensitizing | Same |
7. Technological characteristics comparison
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Issue 1: Design differences do not introduce different questions of safety and effectiveness.
Issue 2: The color master batch of proposed device outer layer is different from the predicate device. This difference will not affect the performance of the mask. Moreover, the proposed product has been tested for biocompatibility and has no potential toxicity or irritation.
Issue 3: The nose piece of the proposed device is made polypropylene with steel wire, which of the predicate device is made by Malleable aluminum wire. The Nose piece is between the inner and outer layers of the mask, which does not contact with the human body directly when used. Moreover, the whole product has been tested for biocompatibility, and the test results confirm that they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.
lssue 4: The Ear-loops of the proposed device are made by spandex, which of the predicate device is made by polyester. The major chemical composition of the spandex 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 they have good biocompatibility, these differences do not introduce different questions of safety and effectiveness.
Issue 5: The level of the proposed device is covered by the predicate device.
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8. Summary of Non-clinical Testing
Disposable Medical Face Mask conforms to the following standards:
ASTM F 2100-19, Standard Specification for Performance of Materials Use in Medical Face Masks.
ISO 10993-1:2018, Biological Evaluation Of Medical Devices - Part 1: Evaluation And Testing Within A Risk Management Process.
Bench testing
The bench testing of Disposable Medical Face Mask include the following tests:
| *Fluid Resistance Performance: | Pass at 80 mmHg |
|---|---|
| *Particulate Filtration Efficiency: | 99.8% |
| *Bacterial Filtration Efficiency: | 99.8% |
| *Differential Pressure: | < 5.0 mm H2O/cm² |
| *Flammability: | Class 1 |
Biocompatibility testing
According to ISO 10993-1:2009, the contact category for the subject device is Limited exposure category A, for devices whose cumulative single, multiple or repeated use or contact is up to 24 hours. The following tests for the subject device were conducted to demonstrate that the subject device conforms to ISO 10993-1:2009 and is biocompatible for its intended use:
-
- In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity,
-
- Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.
-
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin 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 K202710, the Disposable Medical Face Mask models WXDKZ001 and WXDKZ006 are as safe and effective, and performs as well as or better than the legally marketed predicate device cleared under K133070.
§ 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.