(198 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a medical mask, with no mention of AI or ML.
No.
A therapeutic device is used to treat a disease or condition, whereas this medical mask is intended to protect against the transfer of microorganisms, bodily fluids, and particulate materials, which is a preventative measure.
No
A medical mask is a protective barrier device designed to prevent the transfer of microorganisms, not to diagnose medical conditions.
No
The device description clearly states it is a physical medical mask constructed of nonwoven polypropylene materials with ear loops and a nosepiece. The performance studies are related to physical properties like filtration and fluid resistance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting healthcare workers and patients against the transfer of microorganisms, bodily fluids, and particulate materials during procedures. 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 of the mask (layers, materials, ear loops, nosepiece). It doesn't mention any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency, differential pressure, flammability, and biocompatibility. These are tests of the mask's ability to act as a barrier, not tests to diagnose a condition or analyze a sample.
- Lack of IVD Characteristics: There is no mention of:
- Analyzing samples (blood, urine, tissue, etc.)
- Reagents or assays
- Diagnostic results or interpretations
- Use in a laboratory setting for diagnostic purposes
This device is a medical mask, which is a type of personal protective equipment (PPE) used to prevent the spread of infection. It falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
Product codes
FXX
Device Description
The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
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
Adult only
Intended User / Care Setting
healthcare workers
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 tests were conducted to verify that the proposed device met all design specifications as the predicate device. The subject device has been evaluated the safety and performance by lab bench testing as follows according to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance Testing summary:
- Fluid Resistance Performance (mmHg) ASTM F1862: Passed at 80mm Hg (Acceptance Criteria for Level 1: 29 out of 32 pass at 80 mmHg)
- Particulate Filtration Efficiency Performance (%) ASTM F2299: Passed at 99.3% (Acceptance Criteria for Level 1: ≥ 95%)
- Bacterial Filtration Efficiency Performance (%) ASTM F2101: Passed at 98.1% (Acceptance Criteria for Level 1: ≥ 95%)
- Differential Pressure (Delta-P) (mm H2O/cm²) MIL-M-36954C: Passed at 4.8 mmH2O/cm² (Acceptance Criteria for Level 1: 24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
- Cytotoxicity: Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. Result: PASS
- Irritation: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. Result: PASS
- Sensitization: Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. Result: PASS
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance (mmHg) ASTM F1862: Passed at 80mm Hg
- Particulate Filtration Efficiency Performance (%) ASTM F2299: 99.3%
- Bacterial Filtration Efficiency Performance (%) ASTM F2101: 98.1%
- Differential Pressure (Delta-P) (mm H2O/cm²): 4.8 mmH2O/cm²
- Flammability class: Class 1
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.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 3, 2021
Han Zhaoqing Sporting Goods Company Limited % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant LTD Contact Address
Re: K202316
Trade/Device Name: Medical mask (Model: KKF-1A) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 15, 2021 Received: January 15, 2021
Dear Cassie Lee:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (OS) 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,
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
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202316
Device Name Medical mask (Model: KKF-1A)
Indications for Use (Describe)
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided nonsterile.
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)
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510(k) Summary
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Subject Device: Medical mask (Model: KKF-1A) 510(k) Number: K202316
1. Submitter's Information
510(k) Owner's Name: Han Zhaoqing Sporting Goods Company Limited Establishment Registration Number: 3016690756 Address: NO.2-1, Kang tai Street, High-tech zone, Zhaoqing City, Guangdong Province, P.R.China Trade Mark: KOUMASK™ Post Code: 526238 Contact name: Zhang Ming Tel: +86- 138 2551 8595 E-mail: info@koumask.co
Application Correspondent:
Contact Person: Ms. Cassie Lee Guangzhou GLOMED Biological Technology Co., Ltd. Address: 2231, Building 1, Rui Feng Center, Kaichuang Road, Huangpu District, Guangzhou, Guangdong, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared date: August 11, 2020
3. Revision date: February 23, 2021
4. Subject Device Information
Type of 510(k): Traditional Trade Name: Medical mask Model Name: KKF-1A Common Name/Regulation Description: Surgical apparel Classification Name: Mask, Surgical Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlation Class: II
5. Predicate Device Information Predicate Device:
Sponsor: Protect U Guard, LLC. Trade Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) Common Name/Regulation Description: Surgical apparel Classification Name: Mask, Surgical
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510(K) Number: K153409 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulation Class: II
6. Device Description
The Medical mask are four-layer, flat-folded masks constructed of nonwoven polypropylene materials. The mask is provided with ear loops (polyester and polyurethane), and a malleable nosepiece which is placed within the binding for comfort and individualized fit. The mask not made with latex materials, and all materials are being used in currently marketed devices. The mask will be provided in white. The masks are single-use, disposable devices, provided non-sterile.
7. Intended Use / Indications for Use
Medical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate materials. This device is single-use and provided non-sterile.
8. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| Company | Han Zhaoqing Sporting Goods | ||
| Company Limited | Protect U Guard, LLC. | -- | |
| 510 (k) | K202316 | K153409 | -- |
| Trade Name | Medical mask | Protect U Guard Earloop and | |
| Tie-On Mask (Blue, White, or | |||
| Green) | -- | ||
| Classification Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Same |
| Product Code | FXX | FXX | Same |
| Indication for Use | Medical mask is intended for use | ||
| by healthcare workers during | |||
| procedures to protect both | |||
| patients and healthcare workers | |||
| against transfer of | |||
| microorganisms, bodily fluids, and | |||
| particulate materials. This device | |||
| is single-use and provided non- | |||
| sterile. | Earloop Mask and Tie-On | ||
| Mask is intended for use by | |||
| healthcare workers during | |||
| procedures to protect both | |||
| patients and healthcare | |||
| workers against transfer of | |||
| microorganisms, bodily fluids, | |||
| and airborne particles. This | |||
| device is single-use and | |||
| provided non-sterile. | Same | ||
| Intended | |||
| populations | Adult only | Adult only | Same |
| Materials | |||
| Outer facing | |||
| layer | Spunbound Polypropylene | Spunbound Polypropylene | Same |
| Middle filter layer | - | ||
| Melt blown polypropylene | Melt blown Polypropylene | Similar | |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Comparison |
| - | |||
| Polypropylene | Note 1 | ||
| Inner facing | |||
| layer | Spunbound Polypropylene | Spunbound Polypropylene | Same |
| Nose clip | Polyethylene coated steel wire | Aluminum strip | Same |
| Ear loops | Polyester | Urethane Elastic Fiber | Same |
| Note 1 | |||
| Design features | Color: White, | ||
| Ear loops, | |||
| Flat Pleated | Earloop or Tie-On Flat | ||
| Pleated | Similar | ||
| Note 1 | |||
| Mask Style | Flat-pleated | Earloop or Tie-On Flat | |
| Pleated | Same | ||
| Dimensions | 16cm x 10.5cm (±0.5cm) | 9.5cm x 17.7 cm | Similar |
| Note 1 | |||
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance | |||
| Testing | Level 1 (ASTM F2100-19) | Level 1 (ASTM F2100) | Same |
| Note 2 | |||
| Fluid Resistance | |||
| Performance | Pass at 80 mm Hg | ||
| (F1862/F1862M - 17) | Pass at 80 mm Hg | ||
| (F1862/F1862M) | Same | ||
| Particulate Filtration | |||
| Efficiency | 99.3% at 0.1 micron | ||
| (F2299/F2299M – 03 (2017)) | 99.18% at 0.1 micron (ASTM | ||
| F2299/F2299M – 03 (2010)) | Similar | ||
| Note 2 | |||
| Bacterial Filtration | |||
| Efficiency | Pass at 98.1% (ASTM F2101-19) | 99.17% (ASTM F2101-14) | Similar |
| Note 2 | |||
| Differential Pressure | 4.8 mm H2O/cm² (EN 14683: | ||
| 2019, Annex C) | 3.79 mm H2O/cm² (MIL-M- | ||
| 36954C) | Similar | ||
| Note 2 | |||
| Flammability | Class 1 (16 CFR 1610) | Class 1 (16 CFR 1610) | Same |
| Biocompatibility | |||
| Cytotoxicity | |||
| (ISO 10993-5) | Under the conditions of the study, | ||
| the subject device was non- | |||
| cytotoxic. | Under the conditions of the | ||
| study, the device is non- | |||
| cytotoxic. | Same | ||
| Irritation | |||
| (ISO 10993-10) | Under the conditions of the study, | ||
| the subject device was non- | |||
| irritating. | Under the conditions of the | ||
| study, the device is non- | |||
| irritating. | Same | ||
| Sensitization | |||
| (ISO 10993-10) | Under the conditions of the study, | ||
| the subject device was non- | |||
| sensitizing | Under the conditions of the | ||
| study, the device is non- | |||
| sensitizing. | Same |
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Comparison in Detail(s): Note 1:
Although the "Ear loops", "Design features", "Dimensions" and "Middle filter layer" of subject device is a little difference with predicate devices, but the subject device met the performance test and ISO 10993 standards required. So, the differences between the subject devices and predicate devices will not affect the safety and effectiveness.
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Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Performance Testing" of subject device is little difference from predicate devices, but they all met the requirements of the same standard, and subject device is based on the up to date version of standards, which is better. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
Note 3:
Although the "Differential Pressure" of subject device is little difference from predicate devices, but they all met the requirements of the same standard, and subject device is based on the up to date version of standards (in the standard ASTM F2100, the test method for "Differential Pressure" refer to EN 14683 instead of MIL-M-36954C). So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
Non-clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The subject device has been evaluated the safety and performance by lab bench testing as follows according to the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance Testing summary:
| Item | Proposed device | Acceptance Criteria
for Level 1 | Test Results |
|--------------------------------------------------------------------|----------------------------|------------------------------------|----------------------------|
| Fluid Resistance
Performance (mmHg)
ASTM F1862 | Passed at 80mm Hg | 29 out of 32 pass at 80
mmHg | Passed at 80mm
Hg |
| Particulate Filtration
Efficiency Performance (%)
ASTM F2299 | Passed at 99.3% | ≥ 95% | Passed at 99.3% |
| Bacterial Filtration Efficiency
Performance (%)
ASTM F2101 | Passed at 98.1% | ≥ 95% | Passed at 98.1% |
| Differential Pressure (Delta-
P) (mm H2O/cm²)
MIL-M-36954C | Passed at 4.8
mmH2O/cm² | 24 h to 30 d). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
| Test Item | Proposed device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to | |
| be non-cytotoxic. | PASS |
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| Irritation | Under the conditions of the study, the subject device non-polar and polar extracts
were determined to be non-irritating. | PASS |
|---------------|------------------------------------------------------------------------------------------------------------------------------|------|
| Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts
were determined to be non-sensitizing. | PASS |
10. Summary of Clinical Performance Test
No clinical study is included in this submission.
11. Comparison to predicate device and conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202316, the Medical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.