(259 days)
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.
The Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene), Middle Layer filter (Polypropylene Melt-blown Cloth), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.
This document describes the premarket notification (510(k)) for the Sheng Jing Tang Surgical Mask. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" refer to the non-clinical performance and biocompatibility testing conducted to demonstrate substantial equivalence to a predicate device.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
This information is primarily found in Section 7.1 "Performance Test" and Section 7.2 "Biocompatibility Evaluation and Test" of the 510(k) Summary.
Performance Test (Bench Tests)
| Performance Test | Acceptance Criteria | Reported Device Performance (Sheng Jing Tang Surgical Mask) | Result |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | ≥ 29 of 32 pass at 120 mmHg | Pass (96/96) from 3 non-consecutive lots: Lot 1: 32/32 pass at 120 mmHg; Lot 2: 32/32 pass at 120 mmHg; Lot 3: 32/32 pass at 120 mmHg | Passed |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥ 98% | Pass (96/96) from 3 non-consecutive lots: Lot 1: ≥ 98.24%; Lot 2: ≥ 98.78%; Lot 3: ≥ 98.82% | Passed |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥ 98% | Pass (96/96) from 3 non-consecutive lots: Lot 1: ≥ 99.9%; Lot 2: ≥ 99.9%; Lot 3: ≥ 99.9% | Passed |
| Differential Pressure (EN 14683:2019, Annex C & ASTM F2100-20) | < 6.0 mmH2O/cm² | Pass (96/96) from 3 non-consecutive lots: Lot 1: Average 5.56 mmH2O/cm²; Lot 2: Average 5.51 mmH2O/cm²; Lot 3: Average 4.97 mmH2O/cm² | Passed |
| Flammability (16 CFR 1610) | Class 1 | Class 1 Pass (96/96) from 3 non-consecutive lots: Lot 1: Class 1 Pass; Lot 2: Class 1 Pass; Lot 3: Class 1 Pass | Passed |
Biocompatibility Evaluation and Test
| Biocompatibility Test | Acceptance Criteria | Reported Device Performance (Sheng Jing Tang Surgical Mask) | Result |
|---|---|---|---|
| In Vitro Cytotoxicity (ISO 10993-5: 2009) | Non-cytotoxic | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Passed |
| Skin Irritation (ISO 10993-10:2010) | Non-irritating | Under the conditions of the study, the proposed device extract was determined to be non-irritating. | Passed |
| Skin Sensitization (ISO 10993-10:2010) | Non-sensitizing | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing. | Passed |
2. Sample Sizes Used for the Test Set and Data Provenance
- Sample Size for performance tests: For each performance test, 96 samples were used (32 samples from each of 3 non-consecutive lots).
- Sample Size for biocompatibility tests: Not explicitly stated but standard ISO 10993 tests are referenced, implying appropriate sample sizes were used for those specific tests.
- Data Provenance: The tests were non-clinical bench and biocompatibility tests, not human subject data. The company, Liaoning Shengjingtang Biotechnology Co., Ltd., is located in China. The document does not specify the country of origin for the testing labs but implies they were conducted to international standards (ASTM, EN, ISO). These were presumably prospective tests conducted on the manufactured device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
N/A. This is a medical device (surgical mask), and the "ground truth" for its performance and safety is established through standardized laboratory tests against predefined performance parameters (e.g., filtration efficiency, fluid resistance), not through expert consensus on medical images or diagnoses. The "experts" are the testing laboratories and their qualified personnel who conduct the tests according to the specified standards.
4. Adjudication Method for the Test Set
N/A. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving human interpretation (e.g., radiologists reviewing images) to establish a consensus "ground truth." For bench and biocompatibility testing of a physical device, the results are quantitative or qualitative assessments based on defined test methods and equipment, not subjective interpretation requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/imaging devices where human reader performance is being evaluated with and without AI assistance. This document pertains to a physical medical device (surgical mask) and its performance against standard criteria.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
Yes, the studies described are analogous to "standalone" performance for a physical device. The device's performance characteristics (filtration, fluid resistance, etc.) were measured directly, without human intervention in the performance of the mask itself.
7. The Type of Ground Truth Used
The "ground truth" used for this device's evaluation is defined by international and national standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993 series). The device's performance is measured against the criteria established within these standards to ensure it meets the necessary safety and effectiveness requirements for its intended use. This is a form of objective performance data derived from standardized laboratory testing.
8. The Sample Size for the Training Set
N/A. This is not an AI/ML device that requires a "training set" of data. The device is a physical product (surgical mask), and its development and manufacturing processes are iterative but do not involve machine learning training data.
9. How the Ground Truth for the Training Set Was Established
N/A. As this is not an AI/ML device, the concept of a "training set" and establishing ground truth for it does not apply. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and the relevant performance and safety standards.
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January 10, 2022
Liaoning Shengjingtang Biotechnology Co., Ltd. Hai Luan CEO Huamei (Dalian) Health Industry Co., Ltd RM. 956 NO. 60-2 Haixing St, Dalian Tax-Free Zone Dalian, 116001 China
Re: K211260
Trade/Device Name: Sheng Jing Tang Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 28, 2021 Received: December 1, 2021
Dear Hai Luan:
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
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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,
For 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
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Indications for Use
510(k) Number (if known) K211260
Device Name Sheng Jing Tang Surgical Mask
Indications for Use (Describe)
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.
| 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
This 510(k) Summary is being submitted in accordance with the requirements of Title 21. CFR Section 807.92.
The assigned 510(k) number: K211260 Date of Preparation: 11/02/2021
1. Contact Information
1.1 Applicant
Applicant Name: Liaoning Shengjingtang Biotechnology Co., Ltd. Address: 123-11 Huishan St, Shenbei New District, Shenyang, Liaoning, China 110141 Contact Person: Li Ke Title: General Manager Telephone: +86-135-914-61018 Email: 174866792@qq.com
1.2 Consultant
Company: Huamei (Dalian) Health Industry Co., Ltd Address: RM. 956 NO.60-2 Haixing St, Dalian Tax-Free Zone, China, 116001 Contact Person: Luan Hai Telephone: +1 503-559-0930 Email: usfdahuamei@hotmail.com
2. Device Information
Trade Name: Sheng Jing Tang Surgical Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
3. Legally Marketed Primary Predicate Device
Product name: Avianz® Surgical Face Mask 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC.
4. Indication For Use
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.
5. Device Description
The Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene),
Sheng Jing Tang Surgical Mask
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Middle Layer filter (Polypropylene Melt-blown Cloth), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation | 21 C.F.R Section 878.4040 | 21 C.F.R Section 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Intended use | Sheng Jing Tang Surgical Mask isintended for use in healthcaresettings, procedures during whicha face mask is necessary toprotect both patient andhealthcare personnel from transferof body fluids, microorganisms,and particulate material.The device is indicated to beover-the-counter use. Adult only.The device is disposable and isindicated for single use.The device is not provided sterile. | The Disposable SurgicalFace Masks are intended tobe worn to protect both thepatient and healthcarepersonnel from the transferof microorganisms, bodyfluids, and particulatematerial. These face masksare intended for use ininfection control practices toreduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device(s)provided non-sterile. | Same |
| Mask Style | Flat-pleated, earloop, 3 layers | Flat-pleated, earloop, 3 layers | Same |
6. Substantially Equivalent (SE) Comparison
6.1 Material Used
| Comparison Items | Sheng Jing Tang SurgicalMask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene Melt-blowncloth | Melt blown polypropylene filter | Same |
| Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Earloop | Spandex + Nylon | Polyester | *Different¹ |
| Nose piece | Polyethylene +Galvanized Iron wire | Malleable aluminum wire | *Different¹ |
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6.2 Design Features
| Comparison Items | Predicate Device | Comparison | ||
|---|---|---|---|---|
| Sheng Jing Tang Surgical Mask Avianz® Surgical Face Mask | ||||
| (K200847) | ||||
| Use Environment | OTC, or Healthcare or related settings | OTC, or Healthcare or related settings | Same | |
| Single-use/use | Multiple- | Single-use | Single-use | Same |
| Color | Blue | Blue | Same |
6.3 Sterility
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask (K200847) | Comparison |
|---|---|---|---|
| Sterilization | No-Sterile | No-Sterile | Same |
6.4 Dimension
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Length | $17.5\pm0.875$ cm | $17.5\pm1$ cm | *Different1 |
| Width | $9.5\pm0.475$ cm | $9.5\pm1$ cm | *Different1 |
6.5 Effectiveness / Performance
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
|---|---|---|---|
| Resistance to Penetrationby Synthetic bloodASTM F1862/F1862M-17 Standard Test Methodfor Resistance ofMedical Face Masks toPenetration by SyntheticBlood (HorizontalProjection of FixedVolume at a KnownVelocity) | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: 32 Out of 32 pass at 120 mmHgLot 2: 32 Out of 32 pass at 120 mmHgLot 3: 32 Out of 32 pass at 120 mmHg | ≥ 30 Out of 32 pass at 120 mmHg | Same |
| Particulate FiltrationEfficiency ASTMF2299/F2299M-03(2017) Standard TestMethod for Determiningthe Initial Efficiency of | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: ≥ 98.24% | ≥ 99.9% | *Different² |
| Material Used in medicalFace Masks toPenetration byParticulates using LatexSpheres | Lot 2: ≥ 98.78%Lot 3: ≥ 98.82% | ||
| Bacterial FiltrationEfficiency ASTMF2101-2019 StandardTest Method forEvaluating the BacterialFiltration Efficiency(BFE) of Medical FaceMask Materials, Using aBiological Aerosol ofStaphylococcus aureus | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: ≥ 99.9%Lot 2: ≥ 99.9%Lot 3: ≥ 99.9% | ≥98% | *Different³ |
| Differential Pressure EN14683:2019 Medical facemasks- Requirementsand test methods | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lotsLot 1: Average 5.56 mmH20/cm²Lot 2: Average 5.51 mmH20/cm²Lot 3: Average 4.97 mmH20/cm²(EN 14683:2019, Annex C andASTM F2100-20) | 3.0 mmH20/cm² (MILM-36954C) | *Different⁴ |
| Flammability 16 CFR1610 Standard for theFlammability of ClothingTextiles Corrections | Class 1 Pass (96/96) 32 SamplesEach from 3 non-consecutivelotsLot 1: Class 1 PassLot 2: Class 1 PassLot 3: Class 1 Pass | Class 1 | Same |
| 6.6 Safety | |||
| ComparisonItems | Sheng Jing Tang Surgical Mask | Predicate DeviceAvianz® Surgical Face Mask(K200847) | Comparison |
| In Vitro CytotoxicityTestISO 10993-5: 2009 | ISO 10993-5; Under theconditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. | ISO 10993-5; Under theconditions of the study, theproposed device extract wasdetermined to be non-cytotoxic. | Same |
| Skin Irritation TestISO 10993-10:2010 | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-irritating. | Same |
| Skin Sensitization TestISO 10993-10:2010 | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | ISO 10993-10;Under the conditions of thestudy, the proposed deviceextract was determined to benon-sensitizing. | Same |
| Flammability | Class 1 | Class 1 | Same |
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"Different! The difference in the materials, colors, and sizes do not raise additional questions for the device's safety and effectiveness. The subject devices' biocompatibility evaluation test and performed on the final finished device, including all construction materials, color and sizes. The test results indicated that pass the requirements.
*Different? The test was performed in accordance with ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, to determine the Particle Filtration Efficiency. Here, Sheng Jing Tang Surgical Mask compares to Predicate Device that results are very closed by statistics. Thus, this difference does not substantially affect equivalence between the Sheng Surgical Mask and predicate devices.
*Different The test was performed in accordance with ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Materials, using a Biological Aerosol of Staphylococcus aureus the bacterial filtration efficiency (BFE) of the test article. Here, Sheng Jing Tang Surgical Mask compares to Precisate Device that results are very closed by statistics. Thus, this difference does not substantially affect equivalence between the Sheng Jing Tang Surgical Mask and predicate devices.
Different The test result for different pressure for the proposed device is different from predicate devices. The differential pressure test standard has been updated to EN14683:2019, Annex C in ASTM F2100:2020. The differential pressure test of the proposed device was conducted according to EN14683:2019, Annex C, and the test result demonstrates that the differential pressure of the proposed device meets the requirements of level 2 specified in ASTM F2100:2020. Thus, this difference does not substantially affect equivalence between the Sheng Jing Tang Surgical Mask and predicate devices.
7. Nonclinical Test
Nonclinical tests were conducted to verify that the proposed device met all design specifications, as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
7.1 Performance Test:
A bench test was conducted on Sheng Jing Tang Surgical Mask for the proposed device to determine
Sheng Jing Tang Surgical Mask 510(k) number: K211260
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substantial equivalence. The bench tests include the following tests:
| Performance Test | Sheng Jing Tang Surgical Mask | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance PerformanceASTM F1862-17 | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lots | $\geq$ 29 of 32 pass at 120 mmHg | Passed |
| Lot 1: 32 Out of 32 pass at 120 mmHg | |||
| Lot 2: 32 Out of 32 pass at 120 mmHg | |||
| Lot 3: 32 Out of 32 pass at 120 mmHg | |||
| Particulate FiltrationEfficiency ASTM F2299-17 | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lots | $\geq$ 98% | Passed |
| Lot 1: $\geq$ 98.24% | |||
| Lot 2: $\geq$ 98.78% | |||
| Lot 3: $\geq$ 98.82% | |||
| Bacterial Filtration EfficiencyASTM F2101-19 | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lots | $\geq$ 98% | Passed |
| Lot 1: $\geq$ 99.9% | |||
| Lot 2: $\geq$ 99.9% | |||
| Lot 3: $\geq$ 99.9% | |||
| Differential Pressure (Delta P) EN14683:2019, Annex C and ASTMF2100-20. | Pass (96/96) 32 Samples Eachfrom 3 non-consecutive lots | <6.0 mmH20/cm² | Passed |
| Lot 1: Average 5.56 mmH20/cm² | |||
| Lot 2: Average 5.51 mmH20/cm² | |||
| Lot 3: Average 4.97 mmH20/cm² | |||
| ASTM F2100-20) | |||
| Flammability 16 CFR 1610 | Class 1 Pass (96/96) 32 SamplesEach from 3 non-consecutivelotsLot 1: Class 1 PassLot 2: Class 1 PassLot 3: Class 1 Pass | Class 1 | Passed |
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7.2 Biocompatibility Evaluation and Test
Biocompatibility evaluation conducted in accordance with the FDA's 2016 guidance supports that the subject devices are biocompatible.
The biocompatibility test includes the following tests:
- 7.2.1 In Vitro Cytotoxicity Test (ISO 10993-5: 2009 )
- 7.2.2 Skin Irritation Test(ISO 10993-10:2010)
- 7.2.3 Skin Sensitization Test (ISO 10993-10:2010)
| BiocompatibilityEvaluation and Test | Purpose | AcceptanceCriteria | Result |
|---|---|---|---|
| 7.2.1In Vitro Cytotoxicity TestISO 10993-5: 2009 | ISO 10993-5; Under the conditions of the study, theproposed device extract was determined to be non-cytotoxic. | Non-cytotoxic. | Passed |
| 7.2.2Skin Irritation TestISO 10993-10:2010 | ISO 10993-10; Under the conditions of the study, theproposed device extract was determined to be non-irritating. | Non-irritating. | Passed |
| 7.2.3Skin Sensitization TestISO 10993-10:2010 | ISO 10993-10.Under the conditions of the study, the proposed deviceextract was determined to be non-sensitizing. | Non-sensitizing | Passed |
8. Clinical Test Conclusion
No clinical study is included in this submission.
9. Conclusion
The conclusions drawn from the nonclinical tests that demonstrate that Sheng Jing Tang Surgical Mask is as safe, as effective and performs as well as the legally marketed device identified in this submission.
§ 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.