(69 days)
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes. The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric. The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric. The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering. The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100. Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
The provided document is a 510(k) summary for a Surgical Mask (K222335) and does not describe an AI/ML powered medical device. Therefore, the information typically requested regarding acceptance criteria, study details, and ground truth establishment for such devices (e.g., sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) will not be present.
Instead, the document details the performance testing of the surgical mask against established standards for medical face masks. The acceptance criteria are based on ASTM F2100-19 for performance and ISO 10993 for biocompatibility.
Here's a summary based on the provided text for a non-AI/ML device:
1. A table of acceptance criteria and the reported device performance:
| Test | Purpose | Acceptance Criteria per ASTM F2100-19 (AQL=4.0%) | Reported Device Performance (Sterile earloop mask, 175*95mm) | Reported Device Performance (Non-sterile earloop mask, 175*95mm) |
|---|---|---|---|---|
| Fluid Resistance (ASTM F1862) | Verify the fluid resistance of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: Pass at 120 mmHg Level 3: Pass at 160 mmHg | 96 out of 96 pass at 120 mmHg 96 out of 96 pass at 160 mmHg | 96 out of 96 pass at 120 mmHg 94 out of 96 pass at 160 mmHg¹ |
| Bacterial filtration efficiency (BFE) (ASTM F2101) | Verify the bacterial filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% Level 3: ≥98% | 99.4%~99.7% (Average: 99.6%) | >99.9% (Average: >99.9%) |
| Particulate filtration efficiency (PFE) (ASTM F2299) | Verify the particulate filtration efficiency of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: ≥98% Level 3: ≥98% | 97.64%~99.11% ² (Average: 98.38%) | 99.88%~>99.9977% (Average: >99.99%) |
| Differential pressure (Delta-P) (EN 14683) | Verify the differential pressure of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: <6.0 mmH₂O/cm² Level 3: <6.0 mmH₂O/cm² | (2.4~3.4) mmH₂O/cm² (Average: 2.7 mmH₂O/cm²) | (4.3~5.9) mmH₂O/cm² (Average: 5.5 mmH₂O/cm²) |
| Flammability (16 CFR 1610) | Verify the flammability of the proposed device can meet the requirements for Level 2 and 3 specified in ASTM F2100-19. | Level 2: Class 1 Level 3: Class 1 | Class 1 | Class 1 |
| In vitro Cytotoxicity (ISO 10993-5) | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass | Pass |
| Skin Irritation (ISO 10993-10) | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass | Pass |
| Skin Sensitization (ISO 10993-10) | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass | Pass |
Notes:
- ¹ Two samples (one sample per lot in two lots among the three lots) did not meet the acceptance criteria for Fluid Resistance at 160mmHg.
- ² Only one data (97.64%) did not meet the acceptance criteria for Particulate filtration efficiency.
2. Sample size used for the test set and the data provenance:
- For performance tests (Fluid Resistance, BFE, PFE, Differential Pressure, Flammability): Three lots, with 32 samples per lot were used. The provenance is not explicitly stated as country of origin, but the manufacturer is Luoyang Sunmed Devices Co., Ltd. from China. These are prospective tests on manufactured devices.
- For biocompatibility tests (Cytotoxicity, Skin Irritation, Skin Sensitization): The sample size is not explicitly mentioned with numerical values like "32 per lot" as in the performance section, but tests were conducted on the proposed device extract. The provenance is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable for this type of device. The "ground truth" for a surgical mask's performance is established by standardized physical and biological testing methods (e.g., fluid penetration, bacterial filtration, flammability), not by expert consensus or interpretation of images.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable as the tests are objective laboratory measurements against predefined physical and biological criteria, not subjective interpretations requiring adjudicated consensus.
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 as the device is a surgical mask and not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a surgical mask and not an algorithm.
7. The type of ground truth used:
The ground truth is based on standardized test methods and predetermined performance thresholds as defined by standards such as ASTM F2100-19 and ISO 10993 series for medical device performance and biocompatibility.
8. The sample size for the training set:
This is not applicable as the device is a surgical mask and not an AI/ML model that undergoes training.
9. How the ground truth for the training set was established:
This is not applicable as the device is a surgical mask and not an AI/ML model for which a training set and its ground truth would be established.
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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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 11, 2022
Luoyang Sunmed Devices Co., Ltd. % Ms. Grace Liu Consultant Shenzhen Joyantech Consulting Co. Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square, Nanshan District Shenzhen, Guangdong 518000 China
Re: K222335
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 2, 2022 Received: August 3, 2022
Dear Ms. Liu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222335
Device Name Surgical Mask
Indications for Use (Describe)
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile/sterile/sterile/sterile/sterile/sterile/sterile/sterile/ste
| 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 - K222335
1. Contact Details
1.1 Applicant information
| Applicant Name | Luoyang Sunmed Devices Co., Ltd. |
|---|---|
| Address | No. 8 Huaxia Road, Hi-Tech Zone, Luoyang Area of China (Henan)Pilot Free Trade Zone |
| Contact person | Tian Qian |
| Phone No. | +86-18637911566 |
| qtian@suntech-power.com | |
| Date Prepared | 2022-08-02 |
1.2 Submission Correspondent
| Image: Company Logo | Shenzhen Joyantech Consulting Co., Ltd |
|---|---|
| 1713A, 17th Floor, Block A, Zhongguan Times Square, NanshanDistrict, Shenzhen, Guangdong Province, China | |
| Image: Chinese Characters | |
| Phone No. | +86-755-86069197 |
| Contact person | Grace Liu; Field Fu; |
| Contact person's e-mail | grace@cefda.com; field@cefda.com |
| Website | http://www.cefda.com |
2. Device Information
| Trade name | Surgical Mask |
|---|---|
| Common name | Surgical Face Mask |
| Classification name | Mask, Surgical |
| Review Panel | General Hospital |
| Product code | FXX |
| Device Class | II |
| Regulation No. | 21 CFR 878.4040 |
3. Legally Marketed Predicate Device
Primary predicate device
| Trade Name | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) |
|---|---|
| 510(k) Number | K202843 |
| Product Code | FXX |
| Manufacturer | B.J.ZH.F.Panther Medical Equipment Co., Ltd. |
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Additional predicate device
| Trade Name | Surgical Face Mask (Non-sterile) |
|---|---|
| 510(k) Number | K212398 |
| Product Code | FXX |
| Manufacturer | Hubei Kimsoul Industrial Co., Ltd |
4. Device Description
The proposed devices are three-layer, flat pleated masks. It has two design styles, i.e. earloop and tie-on. Each mask is composed of a mask body, a nose piece, two ear loops or four tie tapes.
The mask body is manufactured with three layers, the inner layer and the outer layer are made of polypropylene spunbond nonwoven fabric, and the middle layer is made of polypropylene meltblown nonwoven fabric.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops or four tie tapes welded to the mask body. The elastic ear loops are knitted elastic loops (made of nylon and spandex), and the tie tapes are made of polypropylene nonwoven fabric.
The nose piece is enclosed between the layers of face mask to allow the user to fit the face mask around their nose, which is an iron wire with polypropylene covering.
The proposed devices can simultaneously meet the requirements for the performance class of level 2 and level 3 specified in ASTM F2100.
Both of the two design styles are available non-sterile. They are intended to be single use, disposable devices.
5. Intended Use/Indication for Use
The product is intended to be worn to protect both the patients and healthcare personnel from transfer of microorganisms, body fluids and particulate materials. These masks are intended for adult 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/sterile.
6. Technological Characteristics Comparison
| Comparison item | Proposed Device(K222335) | First Predicate Device(K202843) | Second Predicate Device(K212398) | Comment | |
|---|---|---|---|---|---|
| Manufacturer | Luoyang SunmedDevices Co., Ltd. | B.J.ZH.F.Panther MedicalEquipment Co., Ltd. | HUBEI KIMSOULINDUSTRIAL CO., LTD | None | |
| Product name | Surgical Mask | Surgical Face Masks(Sterile), Surgical FaceMasks (Non-sterile) | Surgical Face Mask(Non-sterile) | None | |
| Product Code | FXX | FXX | FXX | Same | |
| Regulation Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same | |
| Classification | Class II | Class II | Class II | Same | |
| OTC use | Yes | Yes | Yes | Same | |
| Indications for Use | The product is intended tobe worn to protect boththe patients andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerials. These masksare intended for adult usein infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device,providednon-sterile/sterile. | The Surgical Face Mask isintended for single use byoperating room personneland other generalhealthcare workers toprotect both patients andhealthcare workers againsttransfer of microorganisms,blood and body fluids, andparticulate materials. | The masks are intendedto be worn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms, bodyfluids and particulatematerial. These masksare intended for adult usein infection controlpractices to reduce thepotential exposure toblood and body fluids.This is a single use,disposable device(s),provided non-sterile. | Similar | |
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same | |
| Design feature | Ear loop/Tie-on | Ear loop/Tie-on | Ear-loop | Same | |
| Single use | Yes | Yes | Yes | Same | |
| Color | Blue | Blue | White | Same | |
| Specifications anddimensions | 1. 145mm×95mmNose piece:85mm×3.0mmEar loop: 155mm×3.5mmTie tape: N.A.2. 175mm×95mm:Nose piece:100mm×3.0mmEar loop: 190mm×3.5mmTie tape: 890mm×8.5mm | 1. 14.5cm×9cm:Nose clip:85mm×2.9mmEar loop: 180mm×3mmTies: 910mm×10mm2. 17.5cm×9.5cm:Nose clip:100mm×2.9mmEar loop: 180mm×3mmTies: 910mm×10mm | 1. 145mm × 95mmNose piece:95mm×2.8mmEar loop: 160mm×3.5mmTie tape: N.A.2. 175mm×95mmNose piece:105mm×2.8mmEar loop: 165mm×3.5mmTie tape: N.A. | Similar | |
| Sterility | Non-sterile/Sterile | Non-sterile/Sterile | Non-Sterile | Same | |
| Sterilizationmethod | EO (SAL: 10-6) | EO (SAL: 10-6) | N.A. | Same | |
| ASTM F2100 Level | Level 2, Level 3 | Level 2 | Level 3 | Different | |
| Labeling | Complied with 21CFRpart 801 | Complied with 21 CFR part801 | Complied with 21 CFRpart 801 | Same | |
| Materials | |||||
| Outer layer | Polypropylene spunbondnonwoven | Polypropylene spunbondnonwoven | Polypropylene spunbondnonwoven | Same | |
| Middle layer | Polypropylene meltblownnonwoven | Polypropylene meltblownnonwoven | Polypropylene meltblownnonwoven | Same | |
| Inner layer | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | Same | |
| Nose piece | Iron wire with polypropylene covering | Medical polypropylene and Q235 | Polyethylene (PE) | Different | |
| Ear loop | Nylon and spandex | Nylon and spandex | Polyester and Polyurethane | Same | |
| Tie tape | Polypropylene spunbond nonwoven | Polypropylene spunbond nonwoven | N.A. | Same | |
| Performances | |||||
| / | Sterile | Non-sterile | Surgical Face Masks (Sterile), Surgical Face Masks (Non-sterile) | Surgical Face Mask (Non-sterile) | / |
| Fluid Resistance (ASTM F1862) | Pass at 120mmHg and 160mmHg | Pass at 120mmHg and 160mmHg | Pass at 120mmHg | Pass at 160 mmHg | |
| Particulate Filtration Efficiency (ASTM F2299) | Average: 98.38% | Average: >99.99% | Average: 98.98% | Average: 99.6% | |
| Bacterial Filtration Efficiency (ASTM F2101) | Average: 99.6% | Average: >99.9% | Average: 98.92% | Average: ≥99.9% | Different |
| Differential Pressure (Delta P) (EN 14683) | Average: 2.7 mmH2O/cm² | Average: 5.5 mH2O/cm² | Average: 4.4 mmH2O/cm² | Average: 3.7 mmH2O/cm² | |
| Flammability (16CFR 1610) | Class 1 | Class 1 | Class 1 | Class 1 | |
| Biocompatibility | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10; Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating | Same |
Table 1 Technological Characteristics Comparison Table
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The proposed device has the similar indication for use as the two predicate devices as well as comparable technical and biocompatibility properties and characteristics, and the differences don't raise any additional questions for safety and effectiveness, therefore, the proposed device is substantially equivalent to the predicate device.
7. Summary of Non-clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as
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similar to the predicate device. The tests were conducted according to the following standards, and the results conducted on the representative models, the sterile earloop masks and non-sterile earloop masks with the largest size, demonstrated that the proposed device complies with the following standards (see Table 2 and 3):
-
ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process
-
ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for in Vitro cytotoxicity
-
ISO 10993-10:2010 Biological Evaluation of Medical Devices Part 10: Tests for irritation and skin sensitization
-
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
-
ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity)
-
ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus
-
EN 14683:2019+AC:2019 Medical Face Masks Requirements and Test Methods
-
ASTM F2299/F2299M-03(R2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
-
16 CFR 1610 Standard for the Flammability of Clothing Textiles
-
ISO 11135:2014 Sterilization of health-care products Ethylene oxide Requirements for the development, validation and routine control of a sterilization process for medical devices
-
ISO 11737-2:2019 Sterilization of medical devices Microbiological methods Part 2 Tests of sterility performed in the definition, validation and maintenance of a sterilization process
-
ISO 10993-7:2008 Biological evaluation of medical devices Part 7 Ethylene oxide sterilization residuals
-
ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Device
-
ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
-
ASTM F1886M-2016 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection
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| Table 2 Summary of Performance Testing | ||||
|---|---|---|---|---|
| Purpose | AcceptanceCriteriaper ASTMF2100-19(AQL=4.0%) | Results(Statistics of three lots, 32 per lot) | ||
| Test | Sterile erarloopmask, 175*95mm | Non-sterile erarloopmask, 175*95mm | ||
| FluidResistance(ASTM F1862) | Verify the fluidresistance of theproposed device canmeet the requirementsfor Level 2 and 3specified in ASTMF2100-19. | Level 2:Pass at 120mmHg | 96 out of 96 pass at120 mmHg | 96 out of 96 pass at120 mmHg |
| Level 3:Pass at 160mmHg | 96 out of 96 pass at160 mmHg | 94 out of 96 pass at160 mmHg¹ | ||
| Bacterialfiltrationefficiency (BFE)(ASTM F2101) | Verify the bacterialfiltration efficiency ofthe proposed devicecan meet therequirements for Level2 and 3 specified inASTM F2100-19. | Level 2:≥98%Level 3:≥98% | 99.4%~99.7%(Average: 99.6%) | >99.9%(Average: >99.9%) |
| Particulatefiltrationefficiency (PFE)(ASTM F2299) | Verify the particulatefiltration efficiency ofthe proposed devicecan meet therequirements for Level2 and 3 specified inASTM F2100-19. | Level 2:≥98%Level 3:≥98% | 97.64%~99.11% ²(Average: 98.38%) | 99.88%~>99.9977%(Average: >99.99%) |
| Differentialpressure(Delta-P)(EN 14683) | Verify the differentialpressure of theproposed device canmeet the requirementsfor Level 2 and 3specified in ASTMF2100-19. | Level 2:<6.0mmH₂O/cm²Level 3:<6.0mmH₂O/cm² | (2.4~3.4)mmH₂O/cm²(Average: 2.7mmH₂O/cm²) | (4.3~5.9)mmH₂O/cm²(Average: 5.5mmH₂O/cm²) |
| Flammability(16 CFR 1610) | Verify the flammabilityof the proposed devicecan meet therequirements for Level2 and 3 specified inASTM F2100-19. | Level 2:Class 1Level 3:Class 1 | Class 1 | Class 1 |
Table 2 Summary of Performance Testing
Note:
1 Two samples (one sample per lot in two lots among the three lots) don't meet the acceptance criteria.
2 Only one data (97.64%) doesn't meet the acceptance criteria.
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| Test | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| In vitroCytotoxicity(ISO 10993-5) | Verify that the proposed deviceextract is non-cytotoxic. | The extract is non-cytotoxic underthe research conditions. | Pass |
| Skin Irritation(ISO 10993-10) | Verify that the proposed deviceextract is non-irritating. | The polar and non-polar extracts arenon-irritating under the researchconditions. | Pass |
| Skin Sensitization(ISO 10993-10) | Verify that the proposed deviceextract is non-sensitizing. | The polar and non-polar extracts arenon-sensitizing under the researchconditions. | Pass |
Table 3 Summary of Biocompatibility Testing
8. Clinical testing
Clinical testing was not performed for the proposed device.
9. Conclusion
The nonclinical tests demonstrate that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed device (K202843 and K212398).
§ 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.