(418 days)
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile.
Pediatric face masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. The mask is available in the following product sizes: Regular Size (14.5x9cm) and Extra Small Size (12.5x8cm). The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. The masks (both sizes) have decorative patterns, printed with colored inks.
This document describes the performance testing for the Dukal Level 1 Pediatric Face Mask. The device is a medical face mask and the acceptance criteria and performance are based on established standards for such devices.
Here's the breakdown of the acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The device performance is compared to the requirements specified by various test standards, primarily ASTM F2100-19 Level 1 requirements for medical face masks.
| Test Item | Test Standard Methods | Test Requirements | Subject Device Dukal Level 1 Pediatric Face Masks (meets ASTM F2100-19 Level 1 requirements) | Remark |
|---|---|---|---|---|
| Bacterial Filtration Efficiency Performance (BFE) (%) | ASTM F2101 | ≥95% | >99% | Meets requirement |
| Particulate Filtration Efficiency Performance (PFE) (%) | ASTM F2299 | ≥95% | >99% | Meets requirement |
| Differential Pressure (Delta-P) (mm H2O/cm²) | EN 14683 | <5.0 | ≤3.1mmH2O/cm² | Meets requirement |
| Fluid Resistance Performance (mmHg) | ASTM F1862 | 80 mmHg | Passed at 80 mmHg | Meets requirement |
| Flammability | 16 CFR part 1610 | Class I No Flame Spread | Class I No Flame Spread | Meets requirement |
| Biocompatibility | ISO 10993-5, ISO 10993-10 | - Under the conditions of the study, the device does not show cytotoxicity potential.- Under the conditions of the study, the irritation response category of the device is classified as Negligible.- Under the conditions of the study, the device shows no significant evidence of causing skin sensitization. | - Under the conditions of the study, the device did not show cytotoxicity potential.- Under the conditions of the study, the irritation response category of the device was classified as Negligible.- Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Meets requirement |
| Mechanical Hazards (Small parts, sharp edges, and sharp points) | ASTM F963-17 (sec. 4.6, 4.7, and 4.9), 16 CFR Part 1500, 16 CFR Part 1501 | Pass under requirements for CPSIA Section 106 ASTM F963-17 Mechanical Hazards: under As received, Normal Use, Impact, Torque, and Tension conditions | Pass | Meets requirement |
| Total Lead Content Analysis | CPSC-CH-E1002-08.3 & CPSC-CH-E1001-08.3 | Each accessible component shall not contain more than 100 ppm of lead in children's products. | Pass | Meets requirement |
| Phthalate Analysis | CPSC-CH-C1001-09.4 | Children's toy or child care article does not contain phthalate concentrations of more than 0.1 percent (1000 ppm) in plasticized components. | Pass | Meets requirement |
| Safety of Toys – Migration of certain elements | EN 71-3 | The migration of elements from toy materials shall not exceed the limits for restricted elements. | Pass | Meets requirement |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific test (e.g., number of masks tested for BFE). However, the testing conducted is standard for medical devices and typically follows the sample size requirements prescribed by the referenced ASTM, ISO, EN, and CFR standards.
The data provenance is from non-clinical testing conducted according to recognized international and US standards. The data is prospective in the sense that the tests were performed specifically for this device to assess its performance against predefined criteria. The location of the testing is not specified, but these are generally conducted by certified third-party laboratories.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This submission is for a medical face mask, and "ground truth" as typically defined for AI/ML models (e.g., expert consensus on medical images) is not applicable here. The "ground truth" for the test set is established by the specified performance requirements of the referenced international and national standards (ASTM, ISO, EN, CFR). These standards are developed by committees of experts in relevant fields (materials science, microbiology, toxicology, engineering, etc.).
4. Adjudication Method for the Test Set
Not applicable. The tests are laboratory-based and yield quantitative results against pre-defined thresholds. There is no human interpretation or adjudication in the traditional sense of medical image analysis for AI/ML.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, typically involving medical imaging. This submission concerns a physical medical device (face mask) and its material properties and safety, not an AI/ML diagnostic algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, in a conceptual sense. The performance tests reported are for the device itself ("algorithm only" performance in a metaphorical sense), independent of human use or interpretation during the test. The tests measure the intrinsic properties of the mask.
7. The Type of Ground Truth Used
The ground truth used is the performance specifications and safety limits defined by established industry and regulatory standards (e.g., ASTM F2100-19 for masks, ISO 10993 for biocompatibility, etc.). These standards are based on scientific evidence and consensus among experts to ensure the safety and efficacy of medical devices.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set. The device is a physical product whose performance is assessed through laboratory testing.
9. How the Ground Truth for the Training Set was Established
Not applicable, as this is not an AI/ML device.
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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 and 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.
March 29, 2022
Dukal. LLC Megan Quevedo Quality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K210321
Trade/Device Name: Dukal Level 1 Pediatric Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: OXZ Dated: February 22, 2022 Received: February 28, 2022
Dear Megan Quevedo:
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.
Bifeng Qian, M.D., 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) K210321
Device Name Dukal Level 1 Pediatric Face Mask
Indications for Use (Describe)
The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are 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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510(k) SUMMARY K210321 510(k) Premarket Notification for Dukal Level 1 Pediatric Face Mask
| 1. Submitter: | Dukal, LLC2 Fleetwood CourtRonkonkoma NY 11779Phone: 631-656-3800Fax: 631-656-3810 |
|---|---|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan QuevedoQuality and Regulatory Affairs Supervisor2 Fleetwood CourtRonkonkoma NY 11779Telephone Number: 631-656-3800 ext. 133Fax Number: 631-656-3810 |
| 4. Date Summary Prepared: | March 29, 2022 |
| 5. Name of Device: | Dukal Level 1 Pediatric Face Mask |
| 6. Trade Name: | Dukal Level 1 Pediatric Face Mask |
| 7. Common/Classification Name: | Pediatric/Child Facemask |
| 8. Regulation Number: | 21 CFR §878.4040 |
| 9. Device Class: | Class II |
| 10. Regulation Name: | Surgical Apparel |
| 11. Product Code: | OXZ |
| 12. Predicate Device: | Prestige Ameritech Pediatric/Child Face Mask (level 1)• 510k #K160100, cleared on 10/7/2016 |
| 13. Device Description: | Pediatric face masks are intended to be worn by thepatient/child to cover the nose and mouth to provide abarrier for the respiratory tract from microorganisms,body fluids, and particulate material. The mask isavailable in the following product sizes:Regular Size (14.5x9cm) |
Extra Small Size (12.5x8cm)
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| The Dukal Level 1 Pediatric Face Mask (both sizes) are composed of three layers of materials and pleated to form the mask. The inner layer is composed of Polypropylene (Spunbond), the middle layer is Polypropylene (Meltblown) filter material, and the outer layer is polypropylene (Spunbond). | |
|---|---|
| The masks (both sizes) are held in place on wearer with knitted polyester/spandex elastic ear loop and contain a malleable aluminum nosepiece strip. | |
| The masks (both sizes) have decorative patterns, printed with colored inks. | |
| 14. Packaging: | 50 masks/box |
| 15. Indications for Use: | The Dukal Level 1 Pediatric Face Masks are intended to be worn by the patient/child to cover the nose and mouth to provide a barrier for the respiratory tract from microorganisms, body fluids, and particulate material. Recommended ages are 4-12. The face mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile. |
16. Comparison of Technological Characteristics with the Predicate Device:
| Element ofComparison | Predicate Device AmeritechPediatric/ Child Face's Mask(K160100) | Subject Device Dukal Level 1Pediatric Face Masks | Comparison |
|---|---|---|---|
| Indications forUse | The Prestige AmeritechPediatric/Child Face Mask isintended to be worn by thepatient/child. ThePediatric/Child Facemask is asingle use, disposable device,provided non-sterile. ThePediatric/Child Facemask is | The Dukal Level 1 Pediatric FaceMasks are intended to be worn bythe patient/child to cover the noseand mouth to provide a barrier forthe respiratory tract frommicroorganisms, body fluids, andparticulate material. Recommendedages are 4-12. The face mask is | Similar |
| intended to be worn by the patient (ages 4-12) to cover the nose and mouth to provide a barrier for the respiratory tract for microorganisms and particulate materials. The mask is specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. | specifically for use with patients whose age or illness may prevent them from taking necessary precautions in situations where transfer of microorganisms, body fluids, and particulates can occur. The face masks are recommended for use in a healthcare setting with appropriate adult supervision. The Dukal Level 1 Pediatric Face Masks are single use, disposable devices that are provided non-sterile. | ||
| Intended UseSites | Healthcare setting- This FaceMask is recommended for use in a healthcare setting with appropriate adult supervision. | Healthcare setting- The Dukal Level 1 Pediatric Face Mask is recommended for use in a healthcare setting with appropriate adult supervision. | Same |
| Sterilization andShelf Life | The Prestige AmeritechPediatric/Child Face Maskis not provided sterile, has noproposed shelf life/expirationdate, and is not a reprocessedsingle use device. Thedevice is manufactured fromnon-woven materials that arenot impacted by storageconditions or aging and thusdoes not have ashelf life. Storage conditionswill not affect device safety ofeffectiveness. | The Dukal Level 1 Pediatric FaceMask is not provided sterile, has noproposed shelf life/expiration date,and is not a reprocessed single usedevice.The device is manufactured fromnon-woven materials that are notimpacted by storage conditions oraging and thus the device does nothave a shelf life Storage conditions | Same |
| Anthropometry | Based on an anthropometricstudy sample that isrepresentative ofthe current US population inboth gender and racialdistribution,the Prestige AmeritechChild's/Pediatric face mask willprovide adequate coverage tochildren between the ages of 4-12 years old, of weightbetween 24-153 pounds, andof height between 3'3" and5'4". | Based on an anthropometric studysample that is representative of theUS population in both gender andracial distribution, the Dukal Level 1Pediatric Face Mask will provideadequate coverage to childrenbetween the ages of 4-12 years old ofweight between 25-176 pounds, andof height between 3'00" – 5'08". | Similar |
| MaterialComposition | The Prestige AmeritechPediatric/Childs Face Mask | The Dukal Level 1 Pediatric Face Mask | Similar |
| The Prestige AmeritechPediatric/Childs Face Mask ismanufactured using ultrasonicbonding, composed of threelayers of materials and pleatedto form the mask. The innerlayer is composed ofnonwoven, the middle layer ismeltblown polypropylene filtermaterial, and the outerlayer is cellulose.Decorative patterns areprinted with colored inks.Masks are held in place onwearer with knittedpolyester/spandex elasticearloop and contain amalleable aluminum nosepiecestrip. ThePediatric/Child's FaceMask is appropriately sized tothe smaller faces of childrenacross a diverse population.All of the materials used in thisdevice are typical materialscommonly used in theconstruction of Surgical Masksand are being used in currentlegally marketed devices. Thisproduct is not made withnatural rubberlatex. | The Dukal Level 1 Pediatric FaceMask is manufactured usingultrasonic hot sealing, composed ofthree layers of materials and pleatedto form the mask. The inner layer iscomposed of Polypropylene(Spunbond), the middle layer isPolypropylene (Meltblown) filtermaterial, and the outerlayer is polypropylene (Spunbond).Decorative patterns areprinted with colored inks. Masks areheld in place on wearer withpolyester/spandex elastic earloopand contain a malleable aluminumwire nose piece. The Pediatric/Child'sFaceMask is appropriately sized to thesmaller faces of children across adiverse population.All of the materials used in thisdevice are typical materialscommonly used in the constructionof Surgical Masks and are being usedin current legally marketed devices.This product is not made with naturalrubber latex. | Similar | |
| Regulation,Classification,Product Code | Regulation Number: 21 CFR§878.4040Device Class: Class IIRegulation Name: SurgicalApparelProduct Code: OXZ | Regulation Number: 21 CFR§878.4040Device Class: Class IIRegulation Name: Surgical ApparelProduct Code: OXZ | Same |
| Product Color | Decorative patterns areprinted with colored inks | Decorative patterns areprinted with colored inks | Similar |
| Mask Style | Pleated | Pleated | Same |
| Design Features | Ear Loop | Ear Loop | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use; Disposable | Single Use; Disposable | Same |
| Biocompatibility | Under the conditions of eachstudy, the Prestige Ameritech | Under the conditions of each study,the Dukal Level 1 Pediatric Face Mask | Same |
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| Pediatric/Child Face Mask isnon-cytotoxic (ISO 10993-5), isnon-irritating (ISO 10993-10),and is non-sensitizing (ISO10993-10) and has met therequirements per ISO- 10993-1. | is non-cytotoxic (ISO 10993-5), isnon-irritating (ISO 10993-10), is non-sensitizing (ISO 10993-10), and hasmet the requirements per ISO-10993-1. |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Comparison Summary of Non-Clinical Testing Results
| Test Standards | Predicate Device AmeritechPediatric/ Child Face's Mask(K160100) | Subject Device Dukal Level 1Pediatric Face Masks | Remark |
|---|---|---|---|
| ASTM F2101- BacterialFiltration Efficiency (BFE) | 96.32% | >99% | Similar |
| ASTM F2299- ParticulateFiltration Efficiency | 98% | >99% | Similar |
| EN14683- DifferentialPressure | 1.74 mmH2O/cm² (usingDifferential Pressure, MilM36954C) | ≤3.1mmH2O/cm² | Similar |
| ASTM F1862- FluidResistance | n/a | Passed at 80 mmHg | Similar |
| 16 CFR 1610-Flammability | Class I | Class I | Similar |
| Biocompatibility-10993-5-Cytotoxicity & 10993-10-Irritation & Sensitization | Tested under ISO 10993 Standard:Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was categorized as negligible. Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Tested under ISO 10993 Standard:Under the conditions of the study, the device did not show cytotoxicity potential. Under the conditions of the study, the irritation response category of the device was categorized as negligible. Under the conditions of the study, the device showed no significant evidence of causing skin sensitization. | Similar |
| Total Lead ContentAnalysis | Tested under CPSC-CH-E1002-08 | Tested under CPSC-CH-E1002-08.3 & CPSC-CH- | Similar |
| E1001-08.3 | |||
| Phthalate Analysis | Tested under CPSC-CH-C1001-09.3 | Tested under CPSC-CH-C1001-09.4 | Similar |
| Safety of Toys – Migrationof certain elements | Tested under EN 71-3 | Tested under EN 71-3 | Similar |
| Mechanical Hazards (Smallparts, sharp edges, andsharp points) | Tested under ASTM F963-17 (sec.4.6, 4.7, and 4.9), 16 CFR Part1500, 16 CFR Part 1501 | Tested under ASTM F963-17(sec. 4.6, 4.7, and 4.9), 16 CFRPart 1500, 16 CFR Part 1501 | Similar |
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Non-Clinical Test Results:
The subject pediatric face masks were tested and found conformance with following standards:
- ASTM F1862/1862M-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
- ISO 22609:2004, Clothing for protection against infectious agents Medical face masks -● Test method for resistance against penetration by synthetic blood (fixed volume, horizontally projected)
- EN 14683: 2019, Medical Face Masks-Requirements and Test Methods
- AS4381:2015, Single-Use Face Masks for Use in Health Care ●
- 16 CFR 1610, Standard for the Flammability of Clothing Textiles ●
- ASTM F2299/F2299M-03, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- ASTM F2100-19, Standard Specification for Performance of Materials Used in Medical Face Masks
- ISO 10993-5: 2009, Biological evaluation of medical devices Part 5: Tests for in vitro ● cvtotoxicitv
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
- CPSC-CH-E1002-08.3, Standard Operating Procedure for Determining Total Lead (Pb) in Nonmetal Children's Products
- CPSC-CH-C1001-09.4, Standard Operating Procedure for the Determination of Phthalates
- CPSC-CH-E1001-08.3, Standard Operating Procedure for Determining Total Lead (Pb) in ● Children's Metal Products (Including Children's Metal Jewelry)
- EN 71-3:2019, Safety of Toys-Migration of Certain Elements ●
- ASTM F963-17, Standard Consumer Safety Specification For Toy Safety
- 16 CFR Part 1500, Hazardous Substances and Articles: Administration and Enforcement Regulations
- . 16 CFR Part 1501, Method For Identifying Toys And Other Articles Intended For Use By Children Under 3 Years Of Age Which Present Choking, Aspiration, Or Ingestion Hazards Because Of Small Parts
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Summary for Non-Clinical Testing
| Test Item | Test StandardMethods | Test Requirements | Subject Device Dukal Level 1Pediatric Face Masks (meetsASTM F2100-19 Level 1requirements) | Remark |
|---|---|---|---|---|
| BacterialFiltrationEfficiencyPerformance(BFE) (%) | ASTM F2101 | ≥95% | >99% | Meetsrequirement |
| ParticulateFiltrationEfficiencyPerformance(PFE) (%) | ASTM F2299 | ≥95% | >99% | Meetsrequirement |
| DifferentialPressure (Delta-P) (mmH2O/cm²) | EN 14683 | <5.0 | ≤3.1mmH2O/cm² | Meetsrequirement |
| FluidResistancePerformance(mmHg) | ASTM F1862 | 80 mmHg | Passed at 80 mmHg | Meetsrequirement |
| Flammability | 16 CFR part 1610 | Class INo Flame Spread | Class INo Flame Spread | Meetsrequirement |
| Biocompatibility | ISO 10993-5ISO 10993-10 | -Under the conditionsof the study, thedevice does not showcytotoxicity potential.-Under the conditionsof the study, theirritation responsecategory of the deviceis classified asNegligible.-Under theconditions of thestudy, the deviceshows no significantevidence of causingskin sensitization. | -Under the conditions of thestudy, the device did not showcytotoxicity potential.-Under the conditions of thestudy, the irritation responsecategory of the device wasclassified as Negligible.-Under the conditions of thestudy, the device showed nosignificant evidence of causingskin sensitization. | Meetsrequirement |
| Mechanical | Tested under ASTM | Pass under | Pass | Meets |
| Hazards (Smallparts, sharpedges, andsharp points) | F963-17 (sec. 4.6,4.7, and 4.9), 16 CFRPart 1500, 16 CFRPart 1501 | requirements forCPSIA Section 106ASTM F963-17Mechanical Hazards:under As received,Normal Use, Impact,Torque, and Tensionconditions | requirement | |
| Total LeadContentAnalysis | Tested under CPSC-CH-E1002-08.3 &CPSC-CH-E1001-08.3 | Each accessiblecomponent shallnot contain morethan 100 ppm oflead in children'sproducts. | Pass | Meetsrequirement |
| PhthalateAnalysis | Tested under CPSC-CH-C1001-09.4 | Children's toy orchild care articledoes not containphthalateconcentrations ofmore than 0.1percent (1000ppm) inplasticizedcomponents. | Pass | Meetsrequirement |
| Safety of Toys –Migration ofcertainelements | Tested under EN 71-3 | The migration ofelements fromtoy materialsshall not exceedthe limits forrestrictedelements. | Pass | Meetsrequirement |
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Summary for Clinical Testing: Not Applicable. See Anthropometry information in section 16 of this 510k summary. Relevant anthropometric data was searched, appraised, analyzed and summarized to demonstrate that the Dukal Level 1 Pediatric Face Mask will provide adequate coverage to children between the ages of 4-12 years old of weight between 25-176 pounds, and of height between 3'00" – 5′08″.
Conclusions: The conclusion drawn from the nonclinical tests demonstrates that the subject device in this 510(k) submission, Dukal Level 1 Pediatric Face Masks, are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K160100.
§ 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.