(162 days)
The Single-use medical face mask is intended to be worn to protect 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. This is a single-use, disposable device, provided nonsterile.
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' 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 clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided document describes the FDA 510(k) clearance for a "Single-use medical face mask" (Model: HD0969). The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 Level 3 standard for medical face masks.
| Test Methodology | Purpose | Acceptance Criteria for Level 3 | Reported Device Performance (Test Results) | Meets Criteria? |
|---|---|---|---|---|
| Fluid Resistance Performance (mmHg) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Pass at 160mmHg | PASS (Average of 3 batch numbers: 160mmHg) | Yes |
| Particulate Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 98.79%) | Yes |
| Bacterial Filtration Efficiency (%) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | ≥ 98% | PASS (Average of 3 batch numbers: 99.87%) | Yes |
| Differential Pressure (mmH2O/cm²) | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | <6.0 mmH2O/cm² | PASS (Average of 3 batch numbers: 4.7 mmH2O/cm²) | Yes |
| Flammability Class | In order to verify whether the subject equipment meets the performance requirements of ASTM F2100 level 3. | Class 1 | PASS (Class 1) | Yes |
Biocompatibility Testing:
| Test Item | Acceptance Criteria (Implied by PASS result) | Reported Device Performance (Result) | Meets Criteria? |
|---|---|---|---|
| Cytotoxicity | Non-cytotoxic | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Yes |
| Irritation | Non-irritating | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Yes |
| Sensitization | Non-sensitizing | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Yes |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Performance Tests: For the Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, and Differential Pressure tests, the reported results are "Average of 3 batch numbers." This implies testing was performed on samples from at least 3 distinct batches. The exact number of samples per batch or per test is not specified, but the methodology typically involves testing multiple samples to derive an average.
- Data Provenance: The document does not explicitly state the country of origin for the testing data. However, the applicant is "Zhuhai Herald Datanetics Limited." in China, and the correspondent is "Share Info (Guangzhou) Medical Consultant Ltd." also in China, suggesting the testing was likely conducted in China or by labs affiliated with the manufacturer. The tests are based on recognized international standards (ASTM, MIL, ISO), which ensures consistency in methodology. The data is retrospective for the purpose of this 510(k) submission, as it represents tests conducted prior to the submission.
3. Number of Experts and their Qualifications for Ground Truth
- Not Applicable: This submission is for a medical face mask, a physical device, and its performance is evaluated against established, quantitative engineering and biological standards (e.g., filtration efficiency, fluid resistance, biocompatibility). It does not involve interpretation of complex data (like medical images) by human experts to establish "ground truth." Therefore, there is no team of experts establishing ground truth in the way it would be for an AI/ML diagnostic device. The ground truth is the objective measurement against the specified standard.
4. Adjudication Method for the Test Set
- Not Applicable: As the test methods are objective, quantitative measurements against international standards for a physical device, there is no need for expert adjudication of results. The results are Pass/Fail based on the measured values compared to the defined thresholds.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was done. This type of study (comparing human reader performance with and without AI assistance) is typically performed for AI-driven diagnostic or assistive devices, not for physical medical devices like face masks. The performance evaluation here is based on the intrinsic physical and biological properties of the mask.
6. Standalone (Algorithm Only) Performance
- Not Applicable: This is not an AI/ML algorithm. The performance described is inherent to the physical characteristics of the manufactured face mask.
7. Type of Ground Truth Used
- The ground truth for the performance tests (Fluid Resistance, PFE, BFE, Differential Pressure, Flammability) is defined by objective, quantitative measurements against established international consensus standards (ASTM F1862, ASTM F2299, ASTM F2101, MIL-M-36954C, 16 CFR 1610 (Class 1)).
- For biocompatibility, the ground truth is established by biological test results (Cytotoxicity, Irritation, Sensitization) conforming to the principles outlined in ISO 10993-1:2018.
8. Sample Size for the Training Set
- Not Applicable: This device is a physical product, not an AI/ML model that requires training data.
9. How the Ground Truth for the Training Set was Established
- Not Applicable: As there is no training set for an AI/ML model, this question is not relevant.
In summary, the substantial equivalence of the "Single-use medical face mask" (Model: HD0969) was demonstrated through a series of non-clinical, objective performance tests designed to verify compliance with the ASTM F2100 Level 3 standard and biocompatibility requirements. The study does not involve human interpretation or AI algorithms, thus many of the questions related to those types of studies are not applicable.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 22, 2021
Zhuhai Herald Datanetics Limited. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K210391
Trade/Device Name: Single-use medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 11, 2021 Received: June 17, 2021
Dear Cassie Lee:
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.
{1}------------------------------------------------
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 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.
Clarence W. Murray, III, PhD 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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K210391
Device Name
Single-use medical face mask (Model: HD0969)
Indications for Use (Describe)
The Single-use medical face mask is intended to be worn to protect 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. 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
510(k) Summary
510(k) Summary
This summary of 510(K)is being submitted in accordance with the requirement of 21 CFR 807.92.
Subject Device: Single-use medical face mask (Model: HD0969) 510(k) Number: K210391
1. Date of the summary prepared: July 22, 2021
2. Submitter's Information
510(k) Owner's Name: Zhuhai Herald Datanetics Limited. Establishment Registration Number: Applying Address: Building#2, No.1 Pingxi Road 6, Nanping Science and Technology Industrial Park, Zhuhai, Guangdong, China Contact Person: Jackson Leung Email: jacksonleung@heraldata.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: requlatory@share-info.com
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Surgical Face Mask Trade Name: Single-use medical face mask Model Name: HD0969 Review Panel: Surqical Apparel Product Code: FXX Requlation Number: 878.4040 Requlatory Class: 2
4. Predicate Device Information
Sponsor: DemeTECH Corporation Trade Name: DemeMASK Surgical Mask Classification Name: Surgical Face Mask 510(K) Number: K201479 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 878.4040 Regulation Class: 2
{4}------------------------------------------------
5. Indications for Use
The Single-use medical face mask is 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. This is a single-use, disposable device, provided non-sterile,
6. Device Description
The Single-use medical face mask is flat pleated style mask, utilizing ear loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer facing layers are made of spunbonded non-woven, and the middle layer is made of melt-blown non-woven the model of proposed device, ear loops, is held in place over the users' 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 clip contained in the proposed device(s) is in the layers of face mask to allow the user to fit the mask around their nose, which is made of PE coated Tin-plate wire.
The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
| Elements ofComparison | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| Company | Zhuhai Herald Datanetics Limited. | DemeTECH Corporation | -- | |
| 510 (k) Number | K210391 | K201479 | -- | |
| Trade Name | Single-use medical face mask | DemeMASK Surgical Mask | -- | |
| ClassificationName | Surgical Face Mask | Surgical Face Mask | Same | |
| Classification | Class II Device, FXX (21CFR 878.4040) | Class II Device, FXX (21CFR 878.4040) | Same | |
| Indication foruse | The Single-use medical face mask isintended to be worn to protect boththe patient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is asingle-use, disposable device,provided non-sterile. | The Disposable Surgical FaceMasks are intended to be worn toprotect both the patient andhealthcare personnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This is a single use,disposable device providednonsterile. | Same | |
| Material | Outerfacinglayer | Spun-bonded non-woven | Spun-bond polypropylene | SimilarNote 1 |
| Middlelayer | Melt-Blown non-woven | Melt blown polypropylene filter | SimilarNote 1 | |
| Innerfacing | Spun-bonded non-woven | Spun-bond polypropylene | SimilarNote 1 |
7. Summary of Technological Characteristics
Provided below is a comparison of the subject device and predicate device
{5}------------------------------------------------
| Elements ofComparison | Subject Device | Predicate Device | Result | |
|---|---|---|---|---|
| layer | ||||
| Noseclip | PE coated Tin-plate wire | Galvanized wire coated withpolyethylene | SimilarNote 1 | |
| Earloops | Spandex | Spandex and Nylon - Notmade from natural rubberlatex | SimilarNote 1 | |
| Color | white + blue | Not Applicable | SimilarNote 1 | |
| Dimensions | 175mm×95mm | Length: 17.5 cm±1 cmWidth: 9.5 cm±1 cm | SimilarNote 1 | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100Level | Level 3 | Level 3 | Same | |
| Fluid ResistancePerformance | Pass at 160 mmHg | Pass at 160 mmHg | Same | |
| ParticulateFiltrationEfficiency | ≥ 98% | Pass at ≥99% | SimilarNote 2 | |
| BacterialFiltrationEfficiency | ≥ 98% | Pass at ≥99% | SimilarNote 2 | |
| DifferentialPressure | On average of 4.7 mmH2O/cm2 | Average 3.6 mmH2O/cm2 | SimilarNote 2 | |
| Flammability | Class 1 | Class 1 | Same |
Comparison in Detail(s): Note 1:
Although the "Material" "Color" and "Dimensions" of subject device are slightly difference with predicate device, it meets the requirement standard ASTM F2100, ASTM F2101, and ISO 10993. Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from the predicate device, and they all meet the requirements of essential performance standard ASTM F2100.
Summary of Non-Clinical Performance Testing Performance Testing summary
{6}------------------------------------------------
| Test Methodology | Purpose | Acceptance Criteriafor Level 3 | Test Results |
|---|---|---|---|
| Fluid Resistance Performance(mmHg)ASTM F1862 | In order to verify whether the subjectequipment meets the performancerequirements of ASTM F2100 level 3. | Pass at 160mmHg | PASSAverage of 3batch numbers:160mmHg |
| Particulate Filtration EfficiencyPerformance (%)ASTM F2299 | In order to verify whether the subjectequipment meets the performancerequirements of ASTM F2100 level 3. | ≥ 98% | PASSAverage of 3batch numbers:98.79% |
| Bacterial Filtration EfficiencyPerformance (%)ASTM F2101 | In order to verify whether the subjectequipment meets the performancerequirements of ASTM F2100 level 3. | ≥ 98% | PASSAverage of 3batch numbers:99.87% |
| Differential Pressure (Delta-P)(mmH2O/cm²)MIL-M-36954C | In order to verify whether the subjectequipment meets the performancerequirements of ASTM F2100 level 3. | <6.0 mmH2O/cm² | PASSAverage of 3batch numbers:4.7 mmH2O/cm² |
| Flammability Class16 CFR 1610 | In order to verify whether the subjectequipment meets the performancerequirements of ASTM F2100 level 3. | Class 1 | PASSClass 1 |
Biocompatibility Testing Summary:
According to ISO 10993-1: 2018, the nature of body contact for the subject device is the Surface Device category, Skin Contact, and duration of the contact is A-Limited (<24 h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Test Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined tobe non-cytotoxic. | PASS |
| Irritation | Under the conditions of the study, the subject device non-polar and polar extractswere determined to be non-irritating. | PASS |
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extractswere determined to be non-sensitizing. | PASS |
8. Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed device
§ 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.