(236 days)
The Dukal Corporation Level 3 Surgical Face Masks 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.
Face Masks intended to protect health care patients and personnel from the transfer of microorganisms, body fluids and particulate material.
The provided document is a 510(k) summary for the Dukal Corporation Level 3 Surgical Face Masks. This type of document is for regulatory clearance of medical devices, demonstrating substantial equivalence to a predicate device, rather than proving that a device meets particular acceptance criteria through a clinical study. Therefore, much of the requested information about a study is not available in this text, as it describes performance testing results for a medical device (surgical face masks).
However, I can extract the acceptance criteria (defined by ASTM F2100-19 Level 3 requirements for the subject device and ASTM F2100-11 Level 3 requirements for the predicate) and the reported device performance.
Acceptance Criteria and Reported Device Performance
Device: Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On
| Test | Acceptance Criteria (ASTM F2100 Level 3 Requirements) | Reported Device Performance (Dukal Corporation Level 3 Surgical Face Masks) |
|---|---|---|
| ASTM F2101-Bacterial Filtration Efficiency (BFE) | ≥98% | >99.9% |
| ASTM F2299-Particulate Filtration Efficiency | ≥98% | >99% |
| EN 14683-Differential Pressure | <5.0 mmH2O/cm2 | ≤4.6 mmH2O/cm2 |
| ASTM F1862-Fluid Resistance | Pass at 160mmHg (31 out of 32 acceptable) | Pass at 160mmHg (29 out of 32 test articles passed) |
| 16 CFR 1610-Flammability | Class I | Class I |
As indicated in the table above, the Dukal Corporation Level 3 Surgical Face Masks meet or exceed the performance requirements for ASTM F2100-19 Level 3 surgical face masks.
The following information is not available in the provided document, as it pertains to a clinical study design, which is not typically part of a 510(k) submission for this type of device:
- Sample sizes used for the test set and the data provenance: Not applicable. The tests are laboratory-based performance tests, not studies on a test set of data.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for performance tests is established by industry standards (ASTM, EN).
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable. This is not a diagnostic imaging or AI-assisted device.
- Standalone (algorithm only without human-in-the-loop performance): Not applicable. This is a physical medical device (face mask), not an algorithm.
- Type of ground truth used: For the performance data, the ground truth is established by the specified ASTM and EN standards for each test. For biocompatibility, it's defined by ISO 10993 acceptance criteria.
- Sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
March 4, 2021
Dukal Corporation Megan Quevedo Ouality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K201732
Trade/Device Name: Dukal Corporation Level 3 Surgical Face Masks with Ear loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX
Dear Megan Quevedo:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated February 16, 2021. Specifically, FDA is updating this SE Letter to remove proprietary information from the 510k summary as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Ryan Ortega, PhD, OHT4: Office of Surgical and Infection Control Devices, (240-402-2303), Email Ryan.Ortega@fda.hhs.gov.
Sincerely,
Image /page/0/Picture/9 description: The image shows the name "Jessica Mavadia-shukla -S" in a clear, sans-serif font. The text is horizontally oriented and appears to be a title or heading. The name is written in black, and the background is plain.
For Ryan Ortega, PhD
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
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Image /page/1/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the FDA acronym in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
February 16, 2021
Dukal Corporation Megan Quevedo Ouality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K201732
Trade/Device Name: Dukal Corporation Level 3 Surgical Face Masks with Ear Loop, Dukal Corporation Level 3 Surgical Face Masks with Tie On Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 8, 2021 Received: February 11, 2021
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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal
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statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Jessica Mavadia-shukla -S
For CAPT Elizabeth Claverie, M.S. 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) K201732
Device Name
Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Dukal Corporation Level 3 Surgical Face Masks with Tie On
Indications for Use (Describe)
The Dukal Corporation Level 3 Surgical Face Masks 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.
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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K201732 510(k) SUMMARY
510(k) Premarket Notification for Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On
In accordance with the requirements set forth in Title 21 CFR §807.92, we are providing this 510(k) Summary and also notifying you of our intent to manufacture, package, and put into commercial distribution Level 3 Surgical Face Mask with Ear Loop and Level 3 Surgical Mask with Tie On.
| 1. | Submitter: | Dukal Corporation |
|---|---|---|
| 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 Engineer | ||
| 2 Fleetwood Court | ||
| Ronkonkoma NY 11779 | ||
| Telephone Number: 631-656-3800 ext. 133 | ||
| Fax Number: 631-656-3810 | ||
| 4. | Date Summary Prepared: | February 16, 2021 |
| 5. | Name of Device: | Dukal Corporation Level 3 Surgical Face Masks withEar Loop, Dukal Corporation Level 3 Surgical FaceMasks with Tie On |
| 6. | Trade Name: | Dukal Corporation Level 3 Surgical Face Masks withEar Loop, Dukal Corporation Level 3 Surgical FaceMasks with Tie On |
| 7. | Common/Classification Name: | Surgical Mask |
| 8. | Regulation Number: | 21 CFR §878.4040 |
| 9. | Device Class: | Class II |
| 10. | Regulation Name: | Surgical Apparel |
| 11. | Product Code: | FXX |
| 12. | Predicate Device: | Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip |
| (Catalog # AT73635) | ||
| 510k: K192374 | ||
| 13. | Device Description: | Face Masks intended to protect health care patients andpersonnel from the transfer of microorganisms, bodyfluids and particulate material. |
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-
- Packaging:
50 masks/box
- Packaging:
- Indications for Use: The Dukal Corporation surgical masks 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.
16. Comparison of Technological Characteristics with the Predicate Device:
Identification of legally marketed device to which Dukal Corporation is claiming equivalence:
For the Level 3 Surgical Face Masks with Ear loop and Tie On:
Cardinal Health Level 3 Surgical Mask with Anti-Fog Foam Strip (Catalog # AT73635)
- . K192374
- . Cleared: 12/2/2019
17. Substantial Equivalence Comparison Table (Ear loop and Tie On):
| Element ofComparison | Predicate Device Cardinal Health(K192374) Level 3 Surgical Mask withAnti-Fog Foam Strip (Catalog # AT73635) | Subject Device Dukal Corporation(K201732) Level 3 Surgical FaceMasks with Ear Loop and Level 3Surgical Face Masks with Tie On | Comparison |
|---|---|---|---|
| Intended Use | Cardinal Health Level 3 Surgical Maskswith Anti-Fog Foam Strip are intended tobe worn by operating room personneland other general healthcare workers toprotect both patients and healthcareworkers against transfer ofmicroorganisms, blood and body fluids,and airborne particulates. | The Dukal Corporation Level 3surgical masks are intended to beworn by operating room personnelduring surgical procedures toprotect both the surgical patientand the operating room personnelfrom transfer of microorganisms,body fluids, and particulatematerial. | Similar |
| MaterialComposition | Four-layer mask constructed of:1 layer of nonwovenpolyester/polyethylene blend (innerfacing)1 layer of nonwoven polyolefin meltblown (filter media)1 layer of nonwovenpolyester/polyethylene blend (middlelayer)1 layer of polyolefin spunbond material(outer facing) | Outer and Inner Material:Polypropylene (Spunbond)Filter Material: Polypropylene(Meltblown)Nose Piece Material: Malleablealuminum wireEar loop Material: Spandex elastic,polyesterTie On Material: Polypropylene(Spunbond) | Similar |
| Dimensions | 7 inches x 4 inches | 17.5 x 9.5 cm | Similar |
| Mask Style | Pleated | Pleated | Same |
| Design Features | Anti-fog foam strip, ties and malleablenosepiece | Option for Ear Loop & Option for TieOn (both with malleable aluminumwire) | Similar |
| Sterility | Non-Sterile | Non-Sterile | Same |
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| Use | Single Use; Disposable | Single Use; Disposable | Same |
|---|---|---|---|
| Biocompatibility | The Cardinal Health Level 3 SurgicalMask with Anti-Fog Foam Strip wastested in accordance with ISO 10993and passed acceptance criteria. | The device was tested in accordancewith ISO 10993 and passedacceptance criteria under theconditions of the studies.• Under the conditions of thestudy, the device did not showpotential toxicity to L929 cells.Per ISO 10993- 5 Cytotoxicity test• Under the conditions of thestudy, the response of the devicewas categorized as negligible forskin irritation per 10993- 10Irritation test• Under the conditions of thestudy, the device showed nosignificant evidence of causingskin Sensitization per 10993- 10Sensitization test | Similar |
-
- Technical Characteristics: The Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On have similar technological characteristics as and are substantially equivalent to the above respective Cardinal Health Level 3 Surgical Mask with Anti- Fog Foam Strip.
-
- Performance Data: The following performance data were provided in support of the substantial equivalence determination:
Comparison Summary of ASTM F2100 Performance Testing and Biocompatibility Testing Results
| Test | Test Results of Subject DeviceDukal Corporation (K201732)Level 3 Surgical Face Masks withEar Loop and Level 3 SurgicalFace Masks with Tie On(conforms to ASTM F2100-19Level 3 requirements) | Test Results of PredicateDevice Cardinal Health(K192374) Level 3 SurgicalMask with Anti- Fog FoamStrip (Catalog # AT73635)(conforms to ASTM F2100-11 Level 3 requirements) | Comparison |
|---|---|---|---|
| ASTM F2101-BacterialFiltration Efficiency (BFE) | >99.9% | 99.7% (average) | Similar |
| ASTM F2299-ParticulateFiltration Efficiency | >99% | 99.2% (average) | Similar |
| EN 14683-DifferentialPressure | ≤4.6 mmH2O/cm2 | (Referencing Mil-M- 36954C)2.8 mmH2O/cm2 (average) | Similar |
| ASTM F1862-FluidResistance | Pass at 160mmHg (29 out of 32test articles passed) | Pass at 160 mmHg (31 out of32 test articles passed) | Similar |
| 16 CFR 1610-Flammability | Class I | Class I | Same |
20. Conclusions:
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K)
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submission K201732, Dukal Corporation Level 3 Surgical Face Masks with Ear Loop and Level 3 Surgical Face Masks with Tie On are as safe, as effective, and perform as well as or better than the legally marketed predicate device cleared under K192374.
§ 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.