(252 days)
Not Found
No
The device is a surgical mask, and the summary focuses on its filtration and fluid resistance properties, with no mention of AI or ML.
No
The device is a surgical mask intended for protection and infection control, not for treating or preventing disease in a therapeutic sense.
No
Explanation: The device is a surgical mask intended to protect against transfer of microorganisms and body fluids. It does not diagnose any medical conditions.
No
The device is a physical face mask, not a software application. The description and performance studies clearly indicate it is a tangible product designed for physical protection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description reinforces the function as a protective barrier.
- Lack of Diagnostic Elements: There is no mention of analyzing samples (like blood, urine, tissue), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, flammability, breathability) and biocompatibility, which are relevant to its function as a protective barrier, not a diagnostic tool.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
Face Masks intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare personnel
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)
The subject surgical 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 F2101-14, 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)
- MIL-M-36954C Section 4.4.1.2, Military Specification, Mask, Surgical, Disposable
- EN 14683: 2014 Annex B and C, 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
- . ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Key results:
- ASTM F2101- Bacterial Filtration Efficiency (BFE): >99% (Meets requirement of >=98%)
- ASTM F2299- Particulate Filtration Efficiency: >99% (Meets requirement of >=98%)
- Mil-M-36954C, EN14683 -Differential Pressure: 99%
- Particulate Filtration Efficiency: >99%
- Differential Pressure:
§ 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). 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 5, 2021
Dukal Corporation Megan Quevedo Ouality and Regulatory Affairs Engineer 2 Fleetwood Court Ronkonkoma, New York 11779
Re: K201421
Trade/Device Name: Dukal Corporation Level 2 Surgical Mask with Ear Loops; Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield; Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 28, 2021 Received: February 4, 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.
1
542 of the Act); 21 CFR 1000-1050.
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-
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 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
2
Indications for Use
510(k) Number (if known) K201421
Device Name
Dukal Corporation Level 2 Surgical Mask with Ear Loops Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons
Indications for Use (Describe)
The Dukal Corporation Level 2 Surgical Mask with Ear Loops, Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
K201421
In accordance with the requirements set forth in Title 21 CFR §807.92 Prepared on Feb 5, 2021
| 1. | Submitter: | Dukal Corporation
2 Fleetwood Court
Ronkonkoma NY 11779
Phone: 631-656-3800
Fax: 631-656-3810
FDA Registration Number: 2435946 |
|----|---------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 2. | 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 |
| 3. | Name of Device: | Dukal Corporation Level 2 Surgical Mask with Ear
Loops
Dukal Corporation Level 2 Surgical Mask with Ear
Loops and Face Shield
Dukal Corporation Level 2 Surgical Mask with
Adjustable Tie Ons |
| | Trade Name: | Dukal Corporation Level 2 Surgical Mask with Ear
Loops
Dukal Corporation Level 2 Surgical Mask with Ear
Loops and Face Shield
Dukal Corporation Level 2 Surgical Mask with
Adjustable Tie Ons |
| | Common/Classification Name:
Regulation Number:
Device Class:
Regulation Name:
Product Code: | Surgical Mask
21 CFR §878.4040
Class II
Surgical Apparel
FXX |
| 4. | Predicate Device: | San-M Package Co., LTD Level 2 Face Mask Models:
EL20000, EL 20010, TO 20000, and TO 20010
510(K) number: K160269
Cleared: 9/6/2016 |
| 5. | Device Description: | Face Masks intended to be worn to protect both the patient
and healthcare personnel from transfer of microorganisms |
4
body fluids, and particulate material.
Indications for Use: The Dukal Corporation Level 2 Surgical Mask with Ear Loops, 6. Dukal Corporation Level 2 Surgical Mask with Ear Loops and Face Shield, and Dukal Corporation Level 2 Surgical Mask with Adjustable Tie Ons are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These face masks are 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 non-sterile.
7. Comparison of technological characteristics between the predicate and subject devices
| Element of
| Comparison | Predicate Device | Subject Device | Remark |
|---|---|---|---|
| San-M Package Co., LTD Level 2 Face | |||
| Mask Models: EL 20000, EL 20010, TO | |||
| 20000, and TO | |||
| 20010 (K160269) | Dukal Corporation Level 2 Surgical | ||
| Mask with Ear Loops, Dukal | |||
| Corporation Level 2 Surgical Mask | |||
| with Ear Loops and Face Shield, and | |||
| Dukal Corporation Level 2 Surgical | |||
| Mask with Adjustable Tie Ons | |||
| (K201421) | |||
| Indications | |||
| For Use | The surgical face masks are intended to be | ||
| worn to protect both the patient and | |||
| healthcare personnel from transfer of | |||
| microorganisms, body fluids, and | |||
| particulate material. These face masks are | |||
| 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 non-sterile. | The Dukal Corporation Level 2 Surgical | ||
| Mask with Ear Loops, Dukal | |||
| Corporation Level 2 Surgical Mask | |||
| with Ear Loops and Face Shield, and | |||
| Dukal Corporation Level 2 Surgical | |||
| Mask with Adjustable Tie Ons are | |||
| intended to be worn to protect both | |||
| the patient and healthcare personnel | |||
| from transfer of microorganisms, | |||
| body fluids, and particulate material. | |||
| These face masks are 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 non-sterile. | Same | ||
| Material | |||
| Composition | • Outer material: Polypropylene | ||
| • Inner material: Polypropylene | |||
| • Filter Media: | |||
| Polypropylene Spunbond | |||
| Polypropylene Meltblown | |||
| • Nose Clamp: | |||
| Polyethylene coated steel wire | |||
| • Ear loops: | • Outer and Inner Material: Pure | ||
| Polypropylene (Spunbond) | |||
| • Filter Material: | |||
| Polypropylene (Meltblown) | |||
| • Nose Piece Material: | |||
| Malleable aluminum wire | |||
| • Ear loop Material: | |||
| Spandex elastic, polyester | Similar |
5
| Polyester, polyurethane
• Side tapes: Polyester spunbond (ear loops mask only)
• Tie tapes: Polypropylene spunbond or polyester spunbond | | • Tie on Material:
Pure Polypropylene
(Spunbond) | | | |
|------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|--------------------------------------------------------------------------------------|--------------------------------------------|--------------------------------------------------------------------|---------|
| Dimensions | | Length: 90 ± 3 mm;
Width:
175 ± 5 mm | Length: 90 ± 3 mm;
Width:
180 ± 5 mm | 9.5 x 17.5cm | Similar |
| Mask Style | | Flat-pleated | | | Similar |
| Design
Features | | Visor option: polyester | Fluid Shield option: Polyethylene (PE) | | Similar |
| Sterility | | Non-Sterile | | Non-Sterile | Similar |
| Use | | Single Use; Disposable | | Single Use; Disposable | Similar |
| Biocompatibility | 10993-5-
Cytotoxicity | Under the conditions of the studies, the device did not show toxicity to L929 cells. | | Under the conditions of the study, the device was non-cytotoxic. | Similar |
| | 10993-10-
Irritation | Under the conditions of the study, the device was non-irritating. | | Under the conditions of the study, the device was non-irritating. | Similar |
| | 10993-10-
Sensitization | Under the conditions of the study, the device was non-sensitizing. | | Under the conditions of the study, the device was non-sensitizing. | Similar |
| Test Standards | Subject Device (K201421)
(conforms to ASTM F2100-19
Level 2 requirements) | Predicate Device (K160269)
(conforms to ASTM F2100-11
Level 2 requirements) | Comparison |
|------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------------|
| ASTM F2101- Bacterial
Filtration Efficiency (BFE) | >99% | >98% | Similar |
| ASTM F2299- Particulate
Filtration Efficiency | >99% | 99.6% | Similar |
| Mil-M-36954C or
EN14683- Differential
Pressure | ≤4.9 mmH2O/cm2 | Pass at 1.6 mmH2O/cm2 | Similar |
| ASTM F1862- Fluid
Resistance | Pass at 120mmHg (30 out of 32
test articles passed) | Pass at 120 mmHg | Similar |
| 16 CFR 1610-Flammability | Class I | Class I | Similar |
8. Non-clinical test results
The subject surgical 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 F2101-14, 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)
- MIL-M-36954C Section 4.4.1.2, Military Specification, Mask, Surgical, Disposable ●
- EN 14683: 2014 Annex B and C, Medical Face Masks-Requirements and Test Methods
- AS4381:2015, Single-Use Face Masks for Use in Health Care
6
- 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
- . ISO 10993-5: 2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10: 2010, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
| Test Standards | ASTM Level 2 Requirements | Subject Device (K201421) | Remark |
|---|---|---|---|
| ASTM F2101- Bacterial | |||
| Filtration Efficiency | |||
| (BFE) | ≥98% | >99% | Meets requirement |
| ASTM F2299- | |||
| Particulate Filtration | |||
| Efficiency | ≥98% | >99% | Meets requirement |
| Mil-M-36954C, | |||
| EN14683 | |||
| -Differential Pressure |