(114 days)
The Medical 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 Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.
The model of proposed device, Ear-loop, 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 model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose clamp 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 metal core plastic.
The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.
The provided text is a 510(k) summary for a Medical Mask (K210020). It describes the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically focusing on non-clinical performance standards for medical face masks.
Here's a breakdown of the requested information based on the provided document:
Acceptance Criteria and Device Performance
The acceptance criteria for this medical mask are based on established performance standards for surgical masks, primarily ASTM F2100-19 (Standard Specification For Performance of Materials used in Medical Face Masks) for Level 3 categorization, and other supporting standards for specific properties.
Table of Acceptance Criteria and Reported Device Performance:
| Performance Metric | Acceptance Criteria (for Level 3) | Reported Device Performance (K210020) |
|---|---|---|
| Fluid Resistance (ASTM F1862) | Pass at 160 mmHg | Pass at 160 mmHg |
| Particulate Filtration Efficiency (PFE) (ASTM F2299) | > 98% | > 98% |
| Bacterial Filtration Efficiency (BFE) (ASTM F2101) | > 98% | > 98% |
| Differential Pressure (Breathability) (EN 14683:2019) | < 6.0 mm H2O/cm² (or specific ASTM F2100 limits) | 5.0 mm H2O/cm² (< 6.0 mm H2O/cm²) |
| Flammability (16 CFR 1610) | Class 1 | Class 1 |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic effect | Non-cytotoxicity effect |
| Irritation (ISO 10993-10) | Non-irritation | Non-irritation |
| Sensitization (ISO 10993-10) | Non-sensitization | Non-sensitization |
Note: The document explicitly states "Level 3" under the "Comparison item" table, implying the performance results are a demonstration of meeting Level 3 requirements as per ASTM F2100-19.
Study Details:
This submission is for a medical device (Medical Mask), and the "study" refers to the non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device. It's not a clinical study in the typical sense of evaluating patient outcomes or diagnostic accuracy.
-
Sample Size Used for the Test Set and Data Provenance:
- The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., how many masks were tested for BFE, PFE, etc.). These numbers would typically be found in the detailed test reports submitted to the FDA, but they are not included in this 510(k) summary.
- Data Provenance: The testing was conducted as part of a 510(k) submission from Zhende Medical Co., Ltd. in China. The regulatory standards (ASTM, EN, ISO, CFR) are international/US standards. The data is retrospective in the sense that it was collected prior to the 510(k) submission, specifically for the purpose of demonstrating substantial equivalence.
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Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts:
- This is not applicable in the context of this device and testing. For medical masks, "ground truth" is established by the specified performance standards (e.g., a BFE of >98% is the ground truth for BFE at Level 3). The tests themselves are the means of establishing whether the mask meets these pre-defined physical and biological performance characteristics. There isn't a team of human "experts" establishing a "ground truth" through consensus in the way there would be for, say, medical imaging interpretation. The experts involved would be laboratory technicians and engineers performing validated tests according to the standards.
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Adjudication Method for the Test Set:
- Not applicable. Performance testing of physical products against defined standards does not involve an adjudication method in the same way clinical trials or image readings might. The results are quantitative measurements or pass/fail determinations based on predefined criteria.
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If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC study was not done. The document explicitly states: "No clinical tests were performed." MRMC studies are typically used for diagnostic devices involving human interpretation of medical data (e.g., radiology AI tools). This device is a medical mask, which is evaluated based on its physical and biological barrier properties.
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If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This question is slightly misapplied to a medical mask. If interpreted as "was the device's performance evaluated independently of human use for its intended function (e.g., filtration efficiency tested on a machine)?" then yes. The performance metrics like BFE, PFE, fluid resistance, flammability, differential pressure, and biocompatibility are all measured in a standalone laboratory setting, independent of human interaction during the test itself. The mask's performance is the algorithm in this context – its material composition and design dictate its performance.
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The Type of Ground Truth Used:
- The "ground truth" for this device's performance is based on pre-defined, internationally recognized technical standards and specifications. These standards (e.g., ASTM F2100-19 for medical face masks) lay out the specific performance thresholds (e.g., >98% BFE, >98% PFE, <6.0 mm H2O/cm² differential pressure) that a mask must meet to be classified at a certain level (in this case, Level 3). Biocompatibility is also assessed against ISO standards.
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The Sample Size for the Training Set:
- This question is not applicable. The Medical Mask is a physical device, not an AI/machine learning algorithm. Therefore, there is no "training set" in the context of data used to train a model. The "training" in this analogy would be the manufacturing process and quality controls that result in a consistent product.
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How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" for a physical device like a medical mask. The concept of ground truth in this context relates to the established performance requirements of the relevant standards.
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April 28, 2021
Zhende Medical Co., Ltd. % Joyce Yang Consultant Shenzhen Jovantech Consulting Co., Ltd. 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518100 China
Re: K210020
Trade/Device Name: Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 24, 2021 Received: March 29, 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.
Ryan Ortega -S
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) K210020
Device Name Medical Mask
Indications for Use (Describe)
The Medical 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.
| 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: K210020
Date of Summary prepared: April 27, 2021
1. Submission Sponsor
| Applicant Name | Zhende Medical Co., Ltd. |
|---|---|
| Address | Gaobu Town, 312035, Shaoxing, Zhejiang, P.R.China. |
| Contact person | Chen Ming |
| Phone | +86-575-88770363 |
Submission correspondent 2.
| Name | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| Address | 1713A, 17th Floor, Block A, Zhongguan TimesSquare, Nanshan District, Shenzhen |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
Device Identification 3.
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Medical Mask |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
4. Legally Marketed Predicate Device
| Trade Name | Single-use Surgical Mask |
|---|---|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K200923 |
| Product Code | FXX |
| Manufacturer | BYD Precision Manufacturer Co.,Ltd. |
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5. Device Description
The Medical Masks are single use, three-layer, flat masks with ear loops/straps and nose clamp. The Medical Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle laver is made of melt blown polvpropylene filter.
The model of proposed device, Ear-loop, 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 model of proposed device. Tie-on, is held in place over the user's mouth and nose by four ties welded to the face mask. The tie is made of spun-bond polypropylene.
The nose clamp 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 metal core plastic.
The proposed devices are single use, disposable device, provided in both non-sterile and sterile forms.
6. Intended Use/ Indications for Use
The Medical 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.
7. Technological characteristics comparison
The Medical Mask is compared with the predicate device Single-use Surgical Mask(K200923). The product characteristics are shown as follow:
| Comparisonitem | Subject Device (K210020) | Predicate Device (K200923) | 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 |
| The Medical Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These face | The Single-use Surgical FaceMasks are intended to be wornto protect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulate | ||
| Indications forUse | masks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. | material. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device, provided non-sterile. | Same |
| Level | Level 3 | Level 3 | Similar |
| Design feature | Ear-loop, Tie-on Flat Pleated, 3layers | Ear-loop Flat Pleated, 3 layers | Similar |
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | Width: 18.0cm+/-1.0cm,14.0cm +/-1.0cmLength: 9.5cm+/-1.0cm | Width: 17.5cm+/-0.4cmLength: 9.5cm+/-0.4cm | Different |
| Sterile | Non-sterile, Sterile | Non-sterile | Different |
| Sterilizationmethod | EO | / | Different |
| Material | Outer layer: Spun-bondpolypropylene | Outer layer: Spun-bondpolypropylene | Same |
| Middle layer: Melt blownpolypropylene | Middle layer: Melt blownpolypropylene | Same | |
| Inner layer: Spun-bondpolypropylene | Inner layer: Spun-bondpolypropylene | Same | |
| Nose clamp: Metal Core PlasticEar loops: Polyester andspandex/Elastic laminate Straps:Spun-bond polypropylene | Nose piece: Metal Core PlasticEar loops: Polyester | Different | |
| Fluid ResistancePerformance(ASTM F1862) | Pass at 160 mmHg | Pass at 160 mmHg | Same |
| ParticulateFiltrationEfficiency(ASTM F2299) | > 98% | > 98% | Same |
| BacterialFiltrationEfficiency(ASTM F2101) | > 98% | > 98% | Same |
| DifferentialPressure (EN14683:2019) | 5.0mmH2O/cm2( < 6.0mm H2O/cm2) | 5.62 mmH2O/cm2( < 6.0mm H2O/cm2) | Similar |
| Flammability(16 CFR 1610) | Class 1 | Class 1 | Same |
| Cytotoxicity(ISO 10993-5) | Under the conditions of the study,non cytotoxicity effect | Under the conditions of the study,non cytotoxicity effect | Same |
| Irritation (ISO10993-10) | Under the conditions of the study,non irritation | Under the conditions of the study,non irritation | Same |
| Sensitization(ISO 10993-10) | Under the conditions of the study,non sensitization | Under the conditions of the study,non sensitization | Same |
Table 1: General Comparison
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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.
Brief discussion of clinical tests 9.
No clinical tests were performed.
10. Conclusions
The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(K) submission K210020, the Medical Mask is as safe, 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.