(204 days)
The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face 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 nonsterile.
The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
Here's a breakdown of the acceptance criteria and study information for the "MEDICAL FACE MASKS, Model Name: MY020003" based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Performance Tests: | |||
| Bacterial Filtration Efficiency (BFE) | ASTM F2101-19 | ≥98% | 32 pass / 32 tested Accepted |
| Particulate Filtration Efficiency (PFE) | ASTM F2299-03 (2017) | ≥98% | 32 pass / 32 tested Accepted |
| Differential Pressure (ΔP) | EN 14683:2019+AC (2019)(E), Annex C | <6.0 mm H₂O/cm² | 32 pass / 32 tested Accepted |
| Synthetic Blood Penetration Resistance | ASTM F1862M-17 | 120 mmHg | 32 pass / 32 tested Accepted |
| Flammability | 16 CFR Part 1610 (As Amendment In 2008) | (A) There are no burn times; or(B) There is only one burn time and it is equal to or greater than 3.5 seconds; or(C) The average burn time of two or more specimens is equal to or greater than 3.5 seconds. | Class 1 (indicating it meets the criteria for low flammability) |
| Biocompatibility Tests: | |||
| In Vitro Cytotoxicity | ISO 10993-5:2009 | Cell viability reduced to <70% of the blank indicates cytotoxic potential. The 50% extract of the test article should have at least the same or a higher viability than the 100% extract. | Under the conditions of the test, the test article was found to be non-cytotoxic. |
| Skin Sensitization | ISO 10993-10:2010 | Magnusson and Kligman grades of 1 or greater in the test group generally indicate sensitization, provided grades of less than 1 are seen in control animals. If grades of 1 or greater are noted in control animals, then the reactions of test animals which exceed the most severe reaction in control animals are presumed to be due to sensitization. | Under the conditions of the test, the test article was found to be non-sensitizing. |
| Skin Irritation | ISO 10993-10:2010 (using New Zealand white Rabbits) | Calculated based on erythema and edema grades at 24h, 48h, and 72h observations. | Under the conditions of the test, the test article was found to be non-irritating (implied, as it states "non-" and the criteria leads to this conclusion. The table cuts off the full result, but based on the overall conclusion, it passed). |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size for Performance Tests: For BFE, PFE, Differential Pressure, and Synthetic Blood Penetration Resistance, the reported sample size is 32 samples (indicated by "32pass/32tested"). For Flammability, the number of specimens is not explicitly stated but implied to be sufficient for 16 CFR Part 1610 testing (which typically involves multiple specimens).
- Sample Size for Biocompatibility Tests: The documentation does not specify the exact number of L-929 cells for cytotoxicity, guinea pigs for skin sensitization, or New Zealand white Rabbits for skin irritation. It describes the test methods from the ISO standards, which define typical sample sizes.
- Data Provenance: The document does not explicitly state the country of origin of the data or whether it was retrospective or prospective. However, given that it is a 510(k) submission for a Chinese manufacturer (Huizhou Jie Bai Purification Co.,Ltd. in Huizhou, Guangdong, China), it can be inferred that the testing was likely conducted in China, often by contract research organizations (CROs) that adhere to international standards. These tests are part of a regulatory submission, so they are inherently prospective for the purpose of demonstrating device safety and effectiveness.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable to this type of device and study. The "Medical Face Masks" is a physical product, and its performance and biocompatibility are evaluated through standardized laboratory tests (e.g., ASTM, EN, ISO standards), not through expert consensus on diagnostic interpretations. The "ground truth" for these tests is the objective measurement of physical and biological properties against defined standards.
4. Adjudication Method (e.g. 2+1, 3+1, none) for the Test Set
This is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology studies) where an agreement between multiple readers is required to establish a ground truth when a definitive external standard (like pathology) is unavailable. For medical device performance testing, the results are objectively measured according to the specified test methods.
5. 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
This is not applicable. This submission details the performance and biocompatibility of a medical face mask, which is a physical barrier device. It does not involve any AI components, human readers, or diagnostic interpretation, therefore, an MRMC comparative effectiveness study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. As stated, the device is a medical face mask, not an algorithm or AI-powered system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance and biocompatibility of this device is established by objective measurements and observations against pre-defined scientific and regulatory standards. For example:
- Performance: Measured values (e.g., BFE %, PFE %, ΔP, blood penetration resistance) are compared directly to the numerical acceptance criteria specified in the ASTM and EN standards. Flammability is observed and categorized based on burn times.
- Biocompatibility: Cell viability, skin reactions (erythema, edema), and sensitization responses are observed and categorized according to the methodologies and criteria outlined in the ISO 10993 standards and then compared to the acceptance criteria to determine "non-cytotoxic," "non-sensitizing," and "non-irritating."
8. The Sample Size for the Training Set
This is not applicable. The device is not an AI algorithm or a trainable system. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This is not applicable because there is no training set.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 9, 2021
Huizhou Jie Bai Purification Co.,Ltd. Zhong Xin Official Correspondent Dongjiang Road, Liangwu Village, Yuanzhou Town, Boluo County Huizhou, Guangdong 516123 China
Re: K211165
Trade/Device Name: Medical Face Masks, Model Name:MY020003 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 23, 2021 Received: April 19, 2021
Dear Zhong Xin:
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.
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
{1}------------------------------------------------
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 (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,
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known)
Device Name MEDICAL FACE MASKS (model : MY020003)
Indications for Use (Describe)
The "MEDICAL FACE MASKS " is intended to be worn to protect and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face 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 nonsterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 201.Subpart D) | Over-The-Counter Use (21 CFR 201.Subpart C) |
|---|---|
| ----------------------------------------------------------------------- | --------------------------------------------------------------------------------- |
__ 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
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: November 09, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Huizhou Jie Bai Purification Co.,Ltd. |
|---|---|
| Address: | Dongjiang Road, Liangwu Village, Yuanzhou Town, BoluoCounty Huizhou, Guangdong, 516123 China |
| Contact person: | Zhong Xin |
| Title: | Manager |
| E-mail: | zhongxin@suorec.com |
| Tel: | +86-13925539431 |
2. Device Identification
| 510(K) number: | K211165 |
|---|---|
| Trade/Device Name: | MEDICAL FACE MASKS |
| Models: | MY020003 |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K202463 |
|---|---|
| Device Name: | Disposable Surgical Mask |
| Manufacturer: | UNISOURCES GROUP LLC |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
{4}------------------------------------------------
4. Device Description
The "MEDICAL FACE MASKS" is single use, white color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The surgical face masks are manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of polyethylene. The "MEDICAL FACE MASKS" is sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
5. Indication for use
The " MEDICAL FACE MASKS " is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The face 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(s), provided non-sterile.
{5}------------------------------------------------
6. Comparison to Predicate Device
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SEComparisons | Proposed DevicesK211165 | Predicate DeviceK202463 | Similarities/Differences |
|---|---|---|---|
| Name | MEDICAL FACE MASKS | Disposable Surgical Mask | / |
| Model | MY020003 | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Same |
| Intended use | The "MEDICAL FACEMASKS" is intended to beworn to protect both thepatient and healthcarepersonnel from the transfer oficroorganisms, body fluidsand particulate material. Theface mask is intended for usein infection control practicesto reduce the potentialexposure to blood and bodyfluids. This is a single use,disposable device(s),provided non-sterile. | The Disposable SurgicalMask,FILTECH M201 isintended to be worn toprotect both the patient andhealth care personnel fromtransfer of microorganisms,body fluids and particulatematerial.The DisposableSurgical Mask is intended foruse in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle use,disposabledevice(s), provided non-sterile. | Same |
| ASTM F2100Level | Level 2 | Level 2 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | White | Blue outside; white inside | SimilarNote 1 |
| Targetpopulation | Adults | Adults | Same |
| Dimension(length) | 180 mm | $175 \pm 5$ mm | SimilarNote 2 |
| Dimension(width) | 95 mm | $95 \pm 5$ mm | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of | OTC | OTC | Same |
| use | |||
| Material ofOuter layer | Spunbond fabric(Polypropylene) | Spunbond polypropylene | Same |
| Material ofmiddle layer | Meltblown fabric(Polypropylene) | Melt blown polypropylenefilter | Same |
| Material ofinner layer | Spunbond fabric(Polypropylene) | Spunbond polypropylene | Same |
| Material ofear loops | Polyester and Spandex | Spandex | SimilarNote 3 |
| Material ofNose piece | Polyethylene | Malleable polyethylene wire | Same |
| Colorants | / | Polypropylene (PP) masterbatch | SimilarNote 1 |
{6}------------------------------------------------
Note 1: The difference in color does not raise additional risk for safety and effectiveness. Biocompatibility evaluation has been performed on the finished device.
Note 2: The difference in dimension is so negligible that cannot raise additional risk for safety and effectiveness and the performance tests have been conducted on our device proposed, the results show no risk for safety and effectiveness.
Note 3: We introduce a material "Polyester" in ear loop. It shows no risk for safety and effectiveness after performance test and biocompatibility test.
All the differences don't affect the safety and effectiveness which is concluded after all the required testing, so no safety and effectiveness issues relating to the system come into conclusion.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device Medical face masks:
Performance:
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
-
Differential Pressure -Determine breathing resistance or differential pressure as directed in EN 14683:2019,Annex C.
-
Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
{7}------------------------------------------------
- Resistance to Penetration by Synthetic Blood-Determine synthetic blood penetration resistance as specified in Test Method F1862.
| Standard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ASTMF2100-19 | BFE | ASTM F2101-19 | ≥98% | 32pass/32testedAccepted |
| PFE | ASTM F2299-03(2017) | ≥98% | 32pass/32testedAccepted | |
| DifferentialPressure | EN14683 :2019+AC (2019)(E),Annex C | <6.0 | 32pass/32testedAccepted | |
| SyntheticBloodPenetrationResistance | ASTM F1862M-17 | 120mmHg | 32pass/32testedAccepted | |
| Flammability | 16 CFR Part 1610(As Amendment In 2008) | (A) There are no burn times;or(B) There is only one burntime and it is equal to orgreater than 3.5 seconds; or(C) The average burn time oftwo or more specimens isequal to or greater than 3.5seconds. | Class 1 |
-
Flammability-Determine flammability as specified in 16 CFR Part 1610. 6.
Biocompatibility: -
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
-
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation
and skin sensitization.
| Standard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ISO10993-5:2009 | In VitroCytotoxicity | In this study, mammalian L-929 cells were cultured invitro according to ISO 10993-5:2009 to test the potentialcytotoxicity of the test article.The test articles and thecontrol material wereseparately placed in MEMmedium containing 10% fetalbovine serum, and extractedin a 37 °C incubator for 24hours. After the end of theextraction, the cell culturemedium in the 96-well plate(104 cells/well) cultured for 24 | The 50% extract of the testarticle should have at leastthe same or a higher viabilitythan the 100% extract.Otherwise the test should berepeated.The lower the Viab. % value,the higher the cytotoxicpotential of the test article is.If viability is reduced to <70%of the blank, it has acytotoxic potential.The Viab.% of the 100%extract of the test article isthe final result. | Under theconditionsof thetest, thetest articlewas foundto be non-cytotoxic |
| hours was removed andreplaced with thecorresponding extract,cultured in 37℃, 5%CO2, >90% humidity for 24hours. After the culture, themorphology and cell lysis ofthe cells were observedunder the microscope, andthe cytotoxicity of the testsamples was determined byMTT assay. | ||||
| ISO10993-10:2010 | SkinSensitization | we took guinea pigs toobserve the skin sensitizationof the test article according toISO 10993-10: 2010.The test article wereextracted in ConstantTemperature Vibrator at50°C, 60 rpm for 72 h by0.9 % Sodium ChlorideInjection and Sesame Oil.Mix 50:50 (by volume) stableemulsion of Freund'scomplete adjuvant withselected solvent. Intradermalinduction and topicalinduction were operated inthe clipped intrascapularregion of each animal. Afterthe topical induction phasewas completed on day 14, alltest and control animals werechallenged with the testsample. The erythema andedema of the challenge sitewere observed to test thesensitization response of thetest article. According to theMagnusson and Kligmanscales, the response toerythema and edema at eachapplication site of the skinwas described and scored 24hours and 48 hours after thechallenge phase. | Magnusson and Kligmangrades of 1 or greater in thetest group generally indicatesensitization, providedgrades of less than 1 areseen in control animals.If grades of 1 or greater arenoted in control animals, thenthe reactions of test animalswhich exceed the mostsevere reaction in controlanimals are presumed to bedue to sensitization.If the response is equivocal,rechallenge is recommendedto confirm the results fromthe first challenge. Theoutcome of the test ispresented as the frequencyof positive challenge resultsin test and control animals. | Under theconditionsof thetest, thetest articlewas foundto be non-sensitizing |
| SkinIrritation test | we took New Zealand whiteRabbits to observe the skinirritation of the test articleaccording to ISO10993-10:2010.The test article wereextracted in Constant | Use only (24±2) h, (48±2) hand (72±2) h observations forcalculation.After the 72 h grading, allerythema grades plusoedema grades (24±2) h,(48±2) h and (72±2) h were | Under theconditionsof thetest, thetest articlewas found |
{8}------------------------------------------------
{9}------------------------------------------------
9. Conclusion
Information included in this premarket notification supports the substantial equivalence of the proposed Medical face masks. The proposed device has the identical intended use, identical indication for us, identical performance, identical fundamental technology and identical biocompatibility as the predicate device K202463. The results of the testing support a determination of substantial equivalence.
§ 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.