(100 days)
The "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "SURGICAL 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.
The "SURGICAL MASK" is single use, blue 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 MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown 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 iron strip and polypropylene. The "SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
The document provided describes the acceptance criteria and performance of a SURGICAL MASK, Model Name: C015. This is a medical device and not an AI/ML powered device, therefore many of the points in your request are not applicable.
Here's the breakdown of the information available:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria | Reported Performance |
|---|---|---|---|
| Performance: | |||
| 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 | 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 | 160 mmHg | 32 pass / 32 tested, Accepted |
| Flammability | 16 CFR Part 1610 (As Amendment In 2008) | (A) No burn times; or (B) One burn time ≥ 3.5 seconds; or (C) Average burn time of two or more specimens ≥ 3.5 seconds. | Class 1 |
| Biocompatibility: | |||
| In Vitro Cytotoxicity | ISO 10993-5:2009 (via L-929 cell culture and MTT assay) | 50% extract of test article should have at least the same or higher viability than 100% extract. If viability reduced to <70% of blank, it has cytotoxic potential. Viab.% of 100% extract is final result. | Non-cytotoxic |
| Skin Sensitization | ISO 10993-10:2010 (via Guinea Pig Maximization Test) | Magnusson and Kligman grades of 1 or greater in test group generally indicate sensitization (if control < 1). If control ≥ 1, reactions exceeding most severe control reaction are presumed sensitization. | Non-sensitizing |
| Skin Irritation Test | ISO 10993-10:2010 (via New Zealand White Rabbits) | Primary irritation index for test article (calculated from erythema and oedema scores) compared to control. | Non-irritating |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size:
- For performance tests (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance): "32pass/32tested" indicates that 32 samples were likely tested for each of these criteria.
- For Flammability: "Class 1" likely refers to the result of testing a specific number of specimens as per the standard (not explicitly stated, but typically multiple samples).
- For Biocompatibility:
- Cytotoxicity: L-929 cells (implied large number of cells).
- Skin Sensitization: Guinea pigs (implied multiple animals for test and control groups).
- Skin Irritation: New Zealand White Rabbits (implied multiple animals for test and control groups).
- Data Provenance: The document does not specify the country of origin of the data. It does not explicitly state whether the studies were retrospective or prospective, but given they are laboratory tests on a new device, they are inherently prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This section is not applicable as the document describes performance and biocompatibility testing for a medical device (surgical mask), not an AI/ML system that requires expert ground truth for image interpretation or diagnosis. The "ground truth" here is established by standardized test methods and criteria.
4. Adjudication Method for the Test Set
This section is not applicable as the document describes performance and biocompatibility testing for a medical device (surgical mask), not an AI/ML system that requires adjudication for establishing ground truth or resolving discrepancies in interpretations.
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 section is not applicable. The device is a surgical mask, not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This section is not applicable. The device is a surgical mask and does not involve any algorithm or AI.
7. The Type of Ground Truth Used
The "ground truth" for the surgical mask's performance and safety is established by adherence to well-defined, internationally recognized standards and test methods. For example:
- Performance: ASTM F2100-19, ASTM F2101-19, ASTM F2299-03(2017), EN 14683:2019+AC (2019), ASTM F1862M-17, 16 CFR Part 1610. These standards define the parameters and methodologies for testing physical properties like filtration efficiency, breathability, and fluid resistance.
- Biocompatibility: ISO 10993-5:2009 for cytotoxicity and ISO 10993-10:2010 for irritation and sensitization. These standards define the biological response parameters and test procedures.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical product (surgical mask), not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This section is not applicable. The device is a physical product (surgical mask) and does not involve a training set or AI.
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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.
May 7, 2021
Qingdao Hainuo Biological Engineering Co., Ltd. Raphael Wang Director Industrial Park, Jiangshan Town, Laixi City Qingdao, Shandong 266000 China
Re: K210218
Trade/Device Name: SURGICAL MASK, Model Name:C015 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 26, 2021 Received: April 5, 2021
Dear Raphael Wang:
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
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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. 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) K210218
Device Name SURGICAL MASK, Model Name:C015
Indications for Use (Describe)
The "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "SURGICAL 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 non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K210218 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 29 April 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Qingdao Hainuo Biological Engineering Co., Ltd |
|---|---|
| Address: | Industrial Park, Jiangshan Town, Laixi CityQingdao, Shandong, 266000 China |
| Contact person: | Raphael Wang |
| Title: | Director |
| E-mail: | hynaut@outlook.com |
| Tel: | +86-15065420708 |
2. Device Identification
| Trade/Device Name: | SURGICAL MASK, Model Name: C015 |
|---|---|
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K200923 |
|---|---|
| Device Name: | Single-use Surgical Mask |
| Manufacturer: | BYD Precision Manufacturer Co.Ltd. |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
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4. Device Description
The "SURGICAL MASK" is single use, blue 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 MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown 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 iron strip and polypropylene. The "SURGICAL MASK" 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 "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "SURGICAL 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.
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6. Technological Characteristics Comparison
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 Devices | Predicate DeviceK200923 | Similarities/Differences |
|---|---|---|---|
| Name | Surgical Mask | Single-use Surgical Mask | / |
| Model | C015 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use | The Surgical Mask isintended to be worn toprotect both the patient andhealthcare personnel fromthe transfer ofmicroorganisms, 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 Single-use SurgicalMask (Model:FE2311) 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 3 | Level 3 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | Blue | Blue | Same |
| Targetpopulation | Adults | Adults | Same |
| Dimension(length) | $175 \pm 5$ mm | $175 \pm 4$ mm | Similar |
| Dimension(width) | $95 \pm 5$ mm | $95 \pm 4$ mm | Similar |
| 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 | Non-woven fabric(Polypropylene) | Spun-bond polypropylene | Same |
| Material ofmiddle layer | Melt blown fabric(Polypropylene) | Melt blown polypropylenefilter | Same |
| Material ofinner layer | Non-woven fabric(Polypropylene) | Spun-bond polypropylene | Same |
| Material ofear loops | Polyester and Spandex | Polyester | Similar |
| Material ofNose piece | Iron strip and Polypropylene | Metal Core Plastic | Same |
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8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device SURGICAL MASK:
Performance:
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face 1. Masks was conducted on 3 discontinuous lots.
2 . 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
-
Resistance to Penetration by Synthetic Blood-Determine synthetic bloodpenetration resistance as specified in Test Method F1862.
-
Flammability-Determine flammability as specified in 16 CFR Part 1610.
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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 |
|---|---|---|---|---|
| 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 | 160mmHg | 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 | |
| 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 24hours was removed andreplaced with thecorresponding extract,cultured in 37°C, 5%CO2, >90% humidity for 24hours. After the culture, the | 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 the test,the testarticle wasfound tobe non-cytotoxic |
| morphology and cell lysis ofthe cells were observedunder the microscope, andthe cytotoxicity of the testsamples was determined by | ||||
| ISO10993-10:2010 | SkinSensitization | MTT assay.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 the test,the testarticle wasfound tobe 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 ConstantTemperature Vibrator at50°C, 60 rpm for 72 h by0.9 % Sodium ChlorideInjection and Sesame | 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 weretotalled separately for eachtest article and blank for eachanimal. The primary irritationscore for an animal wascalculated | Under theconditionsof the test,the testarticle wasfound tobe non-irritating | |
| Oil.Apply 0.5 ml extracts oftest article or control to2.5 cm x 2.5 cm absorbentgauze patches, and thenapply the patch soaked withthe extract of test article orcontrol directly to the skin oneach side of each rabbit, andthen wrap the applicationsites with a bandage for aminimum of 4 h.At the end ofthe contact time, remove thedressing. The describe andscore the skin reaction forerythema and oedema foreach application site at eachtime interval. Record theappearance of eachapplication site at (1±0.1) h,(24±2) h, (48±2) h and(72±2)h following removal ofthe patches. | by dividing the sum of all thescores by 6 (twotest/observation sites, threetime points).To obtain the primaryirritation index for the testarticle, add all the primaryirritation scores of theindividualanimals and divide by thenumber of animals.When blank or negativecontrol was used, calculatethe primary irritation score forthe controls and subtractthat score from the scoreusing the test material toobtain the primary irritationscore. |
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9. 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.