(418 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a face mask, with no mention of AI or ML technologies.
No.
The device is described as a barrier to microorganisms, body fluids, and particulate material, not as something that provides therapy or treatment.
No
Explanation: The device is a face mask intended to provide a barrier for the respiratory tract. It does not perform any diagnostic functions.
No
The device description clearly outlines physical components (polypropylene layers, ear loops, aluminum nosepiece) and the intended use is a physical barrier, not a software function.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a physical barrier to cover the nose and mouth to protect the respiratory tract from external materials. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of a face mask. It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, fluid resistance, flammability, biocompatibility, etc.). They do not involve testing or analyzing biological samples for diagnostic purposes.
- Lack of IVD Characteristics: There is no mention of reagents, calibrators, controls, or any other elements typically associated with in vitro diagnostic devices.
In summary, the Dukal Level 1 Pediatric Face Mask is a personal protective equipment (PPE) device designed to provide a physical barrier, not an in vitro diagnostic device used to diagnose diseases or conditions by testing samples outside the body.
N/A
Intended Use / 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.
Product codes
OXZ
Device Description
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) 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
4-12
Intended User / Care Setting
healthcare setting with appropriate adult supervision
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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
Clinical Testing: Not Applicable. 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″.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial Filtration Efficiency (BFE): >99%
Particulate Filtration Efficiency (PFE): >99%
Differential Pressure (Delta-P): ≤3.1mmH2O/cm²
Fluid Resistance Performance: Passed at 80 mmHg
Flammability: Class I, No Flame Spread
Biocompatibility: non-cytotoxic, negligible irritation, no significant skin sensitization.
Mechanical Hazards: Pass
Total Lead Content Analysis: Pass
Phthalate Analysis: Pass
Safety of Toys – Migration of certain elements: Pass
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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.
1
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
2
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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3
510(k) SUMMARY K210321 510(k) Premarket Notification for Dukal Level 1 Pediatric Face Mask
| 1. Submitter: | Dukal, LLC
2 Fleetwood Court
Ronkonkoma NY 11779
Phone: 631-656-3800
Fax: 631-656-3810 |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. FDA Registration Number: | 2435946 |
| 3. Regulatory Affairs Contact: | Megan Quevedo
Quality and Regulatory Affairs Supervisor
2 Fleetwood Court
Ronkonkoma NY 11779
Telephone Number: 631-656-3800 ext. 133
Fax 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 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) |
Extra Small Size (12.5x8cm)
4
| 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 of
Comparison | Predicate Device Ameritech
Pediatric/ Child Face's Mask
(K160100) | Subject Device Dukal Level 1
Pediatric Face Masks | Comparison |
|------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Indications for
Use | The Prestige Ameritech
Pediatric/Child Face Mask is
intended to be worn by the
patient/child. The
Pediatric/Child Facemask is a
single use, disposable device,
provided non-sterile. The
Pediatric/Child Facemask is | 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 | 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 Use
Sites | Healthcare setting- This Face
Mask 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 and
Shelf Life | The Prestige Ameritech
Pediatric/Child Face Mask
is not provided sterile, has no
proposed shelf life/expiration
date, and is not a reprocessed
single use device. The
device is manufactured from
non-woven materials that are
not impacted by storage
conditions or aging and thus
does not have a
shelf life. Storage conditions
will not affect device safety of
effectiveness. | The Dukal Level 1 Pediatric Face
Mask is not provided sterile, has no
proposed shelf life/expiration date,
and is not a reprocessed single use
device.
The device is manufactured from
non-woven materials that are not
impacted by storage conditions or
aging and thus the device does not
have a shelf life Storage conditions
| Same |
| Anthropometry | Based on an anthropometric
study sample that is
representative of
the current US population in
both gender and racial
distribution,
the Prestige Ameritech
Child's/Pediatric face mask will
provide adequate coverage to
children between the ages of 4-
12 years old, of weight
between 24-153 pounds, and
of height between 3'3" and
5'4". | Based on an anthropometric study
sample that is representative of the
US population in both gender and
racial distribution, 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". | Similar |
| Material
Composition | The Prestige Ameritech
Pediatric/Childs Face Mask | The Dukal Level 1 Pediatric Face Mask | Similar |
| | The Prestige Ameritech
Pediatric/Childs Face Mask is
manufactured using ultrasonic
bonding, composed of three
layers of materials and pleated
to form the mask. The inner
layer is composed of
nonwoven, the middle layer is
meltblown polypropylene filter
material, and the outer
layer is cellulose.
Decorative patterns are
printed with colored inks.
Masks are held in place on
wearer with knitted
polyester/spandex elastic
earloop and contain a
malleable aluminum nosepiece
strip. The
Pediatric/Child's Face
Mask is appropriately sized to
the smaller faces of children
across a diverse population.
All of the materials used in this
device are typical materials
commonly used in the
construction of Surgical Masks
and are being used in current
legally marketed devices. This
product is not made with
natural rubber
latex. | The Dukal Level 1 Pediatric Face
Mask is manufactured using
ultrasonic hot sealing, 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).
Decorative patterns are
printed with colored inks. Masks are
held in place on wearer with
polyester/spandex elastic earloop
and contain a malleable aluminum
wire nose piece. The Pediatric/Child's
Face
Mask is appropriately sized to the
smaller faces of children across a
diverse population.
All of the materials used in this
device are typical materials
commonly used in the construction
of Surgical Masks and are being used
in current legally marketed devices.
This product is not made with natural
rubber latex. | Similar |
| Regulation,
Classification,
Product Code | Regulation Number: 21 CFR
§878.4040
Device Class: Class II
Regulation Name: Surgical
Apparel
Product Code: OXZ | Regulation Number: 21 CFR
§878.4040
Device Class: Class II
Regulation Name: Surgical Apparel
Product Code: OXZ | Same |
| Product Color | Decorative patterns are
printed with colored inks | Decorative patterns are
printed 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 each
study, the Prestige Ameritech | Under the conditions of each study,
the Dukal Level 1 Pediatric Face Mask | Same |
5
6
7
| Pediatric/Child Face Mask is
non-cytotoxic (ISO 10993-5), is
non-irritating (ISO 10993-10),
and is non-sensitizing (ISO
10993-10) and has met the
requirements per ISO- 10993-1. | is non-cytotoxic (ISO 10993-5), is
non-irritating (ISO 10993-10), is non-
sensitizing (ISO 10993-10), and has
met the requirements per ISO-
10993-1. |
| ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
|---|
Comparison Summary of Non-Clinical Testing Results
| Test Standards | Predicate Device Ameritech
Pediatric/ Child Face's Mask
(K160100) | Subject Device Dukal Level 1
Pediatric Face Masks | Remark |
|-------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|
| ASTM F2101- Bacterial
Filtration Efficiency (BFE) | 96.32% | >99% | Similar |
| ASTM F2299- Particulate
Filtration Efficiency | 98% | >99% | Similar |
| EN14683- Differential
Pressure | 1.74 mmH2O/cm² (using
Differential Pressure, Mil
M36954C) | ≤3.1mmH2O/cm² | Similar |
| ASTM F1862- Fluid
Resistance | 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 Content
Analysis | 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 – Migration
of certain elements | Tested under EN 71-3 | Tested under EN 71-3 | Similar |
| Mechanical Hazards (Small
parts, sharp edges, and
sharp points) | Tested under ASTM F963-17 (sec.
4.6, 4.7, and 4.9), 16 CFR Part
1500, 16 CFR Part 1501 | Tested under ASTM F963-17
(sec. 4.6, 4.7, and 4.9), 16 CFR
Part 1500, 16 CFR Part 1501 | Similar |
8
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
9
Summary for Non-Clinical Testing
| 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 |