(258 days)
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the 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 "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is 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 ear loop is made of Knited nylon and spandex. The nose clip 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 Synthetic iron wire, PP and PE. The "Disposable Medical 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 provided text describes a submission for a Disposable Medical Surgical Mask seeking FDA clearance (K210348) by demonstrating substantial equivalence to a predicate device (K202463).
Here's the analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The provided document includes two tables that effectively serve this purpose, one for general performance and another for biocompatibility.
Performance Test Results:
| Test Item | Test Standard | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| BFE (Bacterial Filtration Efficiency) | ASTM F2101-19 | ≥98% | Accepted (≥98%) |
| PFE (Particulate Filtration Efficiency) | ASTM F2299-03(2017) | ≥98% | Accepted (≥98%) |
| Differential Pressure | EN 14683:2019+AC (2019)(E), Annex C | <6.0 | Accepted (<6.0) |
| Synthetic Blood Penetration Resistance | ASTM F1862M-17 | 120mmHg | Accepted (120mmHg) |
| 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 |
Biocompatibility Test Results:
| Test Method | Purpose | Acceptance Criteria | Reported Device Performance (Results) |
|---|---|---|---|
| ISO 10993-5:2009 In Vitro Cytotoxicity | To test the potential cytotoxicity of the test article on mammalian L-929 cells. Cells were exposed to extracts of the mask, and morphology, cell lysis, and cytotoxicity were observed and determined by MTT assay. | The 50% extract of the test article should have at least the same or a higher viability than the 100% extract. Otherwise, the test should be repeated. If viability is reduced to <70% of the blank, it has a cytotoxic potential. The Viab.% of the 100% extract of the test article is the final result. | Under the condition of the test, the test article was found to be cytotoxic. |
| Skin Sensitization ISO 10993-10:2010 | To observe skin sensitization in guinea pigs after intradermal and topical induction with extracts of the test article. Challenge phase observed for erythema and edema, and scored according to Magnusson and Kligman scales. | 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. If the response is equivocal, rechallenge is recommended to confirm the results from the first challenge. The outcome of the test is presented as the frequency of positive challenge results in test and control animals. | Under the conditions of the test, the test article was found to be non-sensitizing. |
| Skin Irritation test ISO 10993-10:2010 | To observe skin irritation in New Zealand white Rabbits after exposure to extracts of the test article. Extracts were applied to skin, bandages were removed after 4 hours, and skin reactions (erythema and edema) were scored at 1h, 24h, 48h, and 72h. The primary irritation score was calculated. | Use only (24±2) h, (48±2) h and (72±2) h observations for calculation. The primary irritation score for an animal was calculated by dividing the sum of all the scores by 6. To obtain the primary irritation index for the test article, add all the primary irritation scores of the individual animals and divide by the number of animals. Subtract control scores if applicable. | Under the conditions of the test, the test article was found to be non-irritating. |
| Acute systemic toxicity ISO 10993-11:2017 | To evaluate acute systemic toxicity in mice through intraperitoneal injection of a single dose of the test article extract. Mice were observed for adverse clinical reactions, systemic reactions, and weighed daily for three days. Gross necropsy for animals found dead or showing abnormal signs. | (1) If none of the mice treated with the test article extract exhibited a significantly greater biological reactivity than control mice, the test article met the requirements. If two or more animals died, or abnormal behavior occurs in two or more animals, or body weight loss >10% occurs in three or more animals, the test article did not meet the requirements. (2) If slight signs are observed, and no more than one animal showed gross symptoms or died, repeat with ten animals. If all ten animals show no meaningful biological reactivity, the test article met the requirements. | Under the condition of the test, the test article was found to be non-systemic toxicity. |
2. Sample size used for the test set and the data provenance
- Sample Size: For performance testing (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability), the testing was performed using 3 nonconsecutive lots of 32 samples per lot.
- Data Provenance: Not explicitly stated regarding country of origin or specific lab accreditation, but the tests were "conducted below testing" for the proposed device, suggesting the tests were specifically performed for this submission. The lack of further detail on provenance beyond "Proposed Device" suggests these are new tests conducted for the submission. The classification and purpose indicate these are likely laboratory tests rather than human clinical data. The submission is from Weihai Dishang Medical Technology Co., Ltd in Weihai, Shandong, China.
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 to this type of device and study. The "ground truth" for surgical masks is established by objective measurements based on specified ASTM and ISO standards (e.g., filtration efficiency, differential pressure). There are no human experts "establishing ground truth" in the way radiologists establish ground truth for medical images. The acceptance criteria themselves serve as the ground truth.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for subjective interpretations, primarily in imaging studies where multiple readers interpret cases and disagreements need to be resolved. For objective laboratory tests like those performed on a surgical mask, there is no subjective interpretation requiring an adjudication process.
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 information is not applicable. This is a submission for a physical medical device (surgical mask), not an AI-powered diagnostic tool, therefore no MRMC study, human readers, or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
The ground truth used for this device is based on established objective laboratory test results that meet internationally recognized standards (ASTM, EN, ISO) for performance and biocompatibility. These standards define the acceptable range for parameters like filtration efficiency, pressure differential, and biological reactions.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the context of testing a physical medical device like a surgical mask. These are direct performance and safety evaluations.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set involved.
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Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 24, 2021
Weihai Dishang Medical Technology Co., Ltd Ricky Xia Manager Room 406-409, Block C, No.213 Torch Road, Torch High-Tech Industrial Development Zone Weihai, Shandong 264209 China
Re: K210348
Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 3, 2021
Dear Ricky Xia:
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 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, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210348
Device Name Disposable Medical Surgical Mask
Indications for Use (Describe)
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the 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 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: August 25, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Weihai Dishang Medical Technology Co.,Ltd |
|---|---|
| Address: | Room 406-409,Block C,No.213 Torch Road,Torch High-techIndustrial Development Zone,Weihai,Shandong China |
| Contact person: | Ricky.xia |
| Title: | Manager |
| E-mail: | ricky.xia@dishang.com |
| Tel: | +86- 18663126766 |
2. Device Identification
| 510(K) number: | K210348 |
|---|---|
| Trade/Device Name: | Disposable Medical Surgical Mask |
| Models: | DSAL2-WHITE, DSAL1-WHITE |
| 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 |
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4. Device Description
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is 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 ear loop is made of Knited nylon and spandex. The nose clip 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 Synthetic iron wire, PP and PE. The "Disposable Medical 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 " Disposable Medical Surgical Mask " is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorqanisms, 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.
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6. Technological Characteristic Comparison to Predicate Device
Comparison to the predicate devices summarized in the following table
| SEComparisons | Proposed DeviceDSAL2-WHITEK210348 | Proposed DeviceDSAL1-WHITEK210348 | Predicate DeviceK202463 | Comparison |
|---|---|---|---|---|
| Name | Disposable Medical SurgicalMask | Disposable Medical SurgicalMask | Disposable Surgical Mask | / |
| Model | DSAL2-WHITE | DSAL1-WHITE | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Class 2 | Same |
| Intended use | The "Disposable MedicalSurgical Mask" is intended tobe worn to protect both thepatient and healthcarepersonnel from the transfer ofmicroorganisms, body fluidsand particulate material. Theface mask is intended for usein infection control practices toreduce the potential exposureto blood and body fluids. Thisis a single use, disposabledevice(s), provided non-sterile. | The "Disposable MedicalSurgical Mask" is intended to beworn to protect both the patientand healthcare personnel fromthe transfer of microorganisms,body fluids and particulatematerial. The face mask isintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device(s), providednon-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 1 | Level 2 | DifferentNote 1 |
| Mask Styles | Flat Pleated | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | 3 | Same |
| Color | White | White | Blue outside; white inside | SimilarNote 2 |
| Targetpopulation | Adults | Adults | Adults | Same |
| Dimension(length) | $175 mm\pm 5 mm$ | $175 mm\pm 5 mm$ | $175 \pm 5 mm$ | Same |
| Dimension(width) | $95 mm\pm 5 mm$ | $95 mm\pm 5 mm$ | $95 \pm 5 mm$ | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Self-suction filter mask | Same |
| Environment ofuse | OTC | OTC | OTC | Same |
| Material ofOuter layer | Spunbond fabric(Polypropylene) | Spunbond fabric(Polypropylene) | Spunbond polypropylene | Same |
| Material ofmiddle layer | Meltblown fabric(Polypropylene) | Meltblown fabric (Polypropylene) | Melt blown polypropylenefilter | Same |
| Material ofinner layer | Spunbond fabric(Polypropylene) | Spunbond fabric(Polypropylene) | Spunbond polypropylene | Same |
| Material ofear loops | Knitted nylon and spandex | Knitted nylon and spandex | Spandex | SimilarNote 3 |
| Material ofNose clip | Synthetic iron wire,PP and PE | Synthetic iron wire,PP and PE | Malleable polyethylene wire | SimilarNote 3 |
| Colorants | / | / | Polypropylene (PP) masterbatch | SimilarNote 2 |
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| Performance | |||||
|---|---|---|---|---|---|
| Test item | Test standard | Proposed DeviceDSAL2-WHITEK210348 | ProposedDeviceDSAL1-WHITEK210348 | PredicateDeviceK202463 | Remark |
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| BFE | ASTM F2101-19 | ≥98% | ≥98% | ≥98% | Same |
|---|---|---|---|---|---|
| PFE | ASTM F2299-03(2017) | ≥98% | ≥98% | ≥98% | Same |
| Differential Pressure | EN14683 :2019+AC (2019)(E)Annex C | <6.0 | <6.0 | <6.0 | Same |
| Synthetic BloodPenetration Resistance | ASTM F1862M-17 | 120mmHg | 120mmHg | 120mmHg | Same |
| Flammability | 16 CFR Part 1610(As Amendment In 2008) | Class 1 | Class 1 | Class 1 | Same |
| Biocompatibility | |||||
|---|---|---|---|---|---|
| Test item | Test standard | Proposed DeviceDSAL2-WHITEK210348 | Proposed DeviceDSAL1-WHITEK210348 | Predicate DeviceK202463 | Remark |
| Cytotoxicity | ISO 10993-5:2009 | toxicity | toxicity | No Cytotoxicity | Different - Note 4 |
| Acute systemic toxicity | ISO 10993-11:2017 | No systemic toxicity | No systemic toxicity | / | |
| Skin sensitization | ISO 10993-10:2010 | No Irritation | No Irritation | No Irritation | Same |
| Skin irritation | 10:2010 | No Sensitization | No Sensitization | No Sensitization | Same |
Note 1: In this submission, we propose two model products, one is level 2, both of these models are subjected ASTM F2100-2019 tests.
Note 2: There is a difference in color.
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Note 3:
We introduce materials "Knited nylon and spandex" in ear loop and materials "Synthetic iron wire, PP and PE" in nose clip.
Note 4:
We evaluated the In vitro cytotoxicity of surgical mask in accordance with ISO 10993-5:2009, the results showed potential toxicity to L929 cells, additionally we evaluated acute systemic toxicity of surgical mask in accordance with ISO 10993-11:2017, result showed no evidence of systemic toxicity from the extract.
8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device Disposable Medical Surgical Mask conducted below testing:
Performance: (Testing was performed using 3 nonconsecutive lots of 32 samples per lot)
-
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 3.
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 5. resistance as specified in Test Method F1862.
- Flammability-Determine flammability as specified in 16 CFR Part 1610.
| Test item | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| BFEASTM F2101-19 | The purpose of the testing to demonstrate the BFE of the device. | ≥98% | Accepted |
| PFEASTM F2299-03(2017) | The purpose of the testing to demonstrate the PFE of the device. | ≥98% | Accepted |
| Differential PressureEN14683 :2019+AC(2019)(E), Annex C | The purpose of the testing to demonstrate the Differential pressure of the device. | <6.0 | Accepted |
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| Synthetic BloodPenetrationResistance ASTMF1862M-17 | The purpose of the testing todemonstrate the Synthetic BloodPenetrationResistance of the device | 120mmHg | Accepted |
|---|---|---|---|
| Flammability16 CFR Part 1610(As Amendment In2008) | The purpose of the testing todemonstrate the Flammability of thedevice | (A) There are no burntimes; or(B) There is only one burntime and it is equal to orgreater than 3.5 seconds;or(C) The average burn timeof two or more specimensis equal to or greater than3.5seconds. | Class 1 |
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Biocompatibility:
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
-
- I SO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation
and skin sensitization.
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic
toxicity.
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| ISO 10993-5:2009 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 themorphology and cell lysis ofthe cells were observedunder the microscope, andthe cytotoxicity of the test | 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 the condition ofthe test, the test articlewas found to becytotoxic |
| samples was determined byMTT assay. | |||
| Skin SensitizationISO 10993-10:2010 | 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 the conditions ofthe test, the test articlewas found to be non-sensitizing |
| Skin Irritation testISO 10993-10:2010 | 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 Oil.Apply 0.5 ml extracts of testarticle or control to2.5 cm x 2.5 cm absorbentgauze patches, and thenapply the patch soaked with | 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 weretotaled separately for eachtest article and blank for eachanimal. The primary irritationscore for an animal wascalculatedby dividing the sum of all thescores by 6 (twotest/observation sites, threetime points). | Under the conditions ofthe test, the test articlewas found to be non-irritating |
| the 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. | 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. | ||
| Acute systemictoxicityISO 10993-11:2017 | A single dose of test articleextract was injected into thedesignated group of miceintraperitoneally at the doselevel of 50 mL/kg bw. Thenegative control liquid wasinjected similarly into theseparate group of designatedcontrol mice.Mice were observed for anyadverse clinical reactionsimmediately after injection,and then the animals werereturned to their cages. Theanimals were observed forsigns of systemic reactionsat4,24,48 and 72 hours afterinjection and weighed dailyfor three days after dosing.Any animal found dead orshowed abnormal signswere subjected to grossnecropsy. | (1) If during the observationperiod of an acute systemictoxicity test none of the micetreated with the test articleextract exhibited asignificantly greater biologicalreactivity than control mice,the test article met therequirements. If two or moreanimals died, or if abnormalbehavior such asconvulsions or prostrationoccurs in two or moreanimals, or if body weightloss greater than10 % occurs in three or moreanimals, the test article didnot meet the requirements.(2)If any animals treated withthe sample exhibited onlyslight signs of biologicalreactivity, andno more thanone animal showed grosssymptoms of biologicalreactivity or died, repeat thetesting using groups of tenanimals. On the repeat test,if all ten animals treated withthe test article extractexhibited no scientificallymeaningful biologicalreactivity above the vehiclecontrol animals during theobservation period, the testarticle met the requirements. | Under the condition ofthe test, the test articlewas found to be non-systemic toxicity |
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9. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210348, the Disposable Medical Surgical Mask (model: DSAL2-WHITE, DSAL1-WHITE), are as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K202463.
§ 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.