(714 days)
The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single-use only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
The KNH Surgical Face Mask (Models 1MMAB50DM2 (Level 1) and 1MMAB50DM3 (Level 2)) underwent non-clinical testing to demonstrate substantial equivalence to the predicate device K160269. The acceptance criteria and reported device performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | To ensure adequate resistance to fluids | 1MMAB50DM2 (Level 1): At least 29/32 pass at 80 mmHg for three non-consecutive lots1MMAB50DM3 (Level 2): At least 29/32 pass at 120 mmHg for three non-consecutive lots | Pass | Pass |
| Particulate Filtration Efficiency ASTM F2299 | To demonstrate adequate resistance to particulate transmission | 1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots | Pass at Avg. 99.49 % (Level 1)Pass at Avg. 99.31% (Level 2) | Pass |
| Bacterial Filtration Efficiency ASTM F2101 | To demonstrate adequate resistance to bacterial penetration | 1MMAB50DM2 (Level 1): At least 29/32 pass at 95% or better efficiency for three non-consecutive lots1MMAB50DM3 (Level 2): At least 29/32 pass at 98% or better efficiency for three non-consecutive lots | Greater than 99% (Level 1)Greater Than 99% (Level 2) | Pass |
| Differential Pressure Mil M36945 Appendix C | To demonstrate adequate breathability | 1MMAB50DM2 (Level 1): At least 29/32 pass at 5 mmH₂O/cm² or less for three non-consecutive lots1MMAB50DM3 (Level 2): At least 29/32 pass at 6 mmH₂O/cm² or less for three non-consecutive lots | Pass at 2.5 to 2.9 mmH₂O/cm² (Level 1)Pass at 2.7 to 3.7 mmH₂O/cm² (Level 2) | Pass |
| Flammability 16 CFR 1610 | To demonstrate adequate flammability resistance | At least 29/32 samples at class 1 | Class 1 | Pass |
| Biocompatibility Skin Sensitization ISO 10993-10 | To demonstrate low skin sensitization potential | Under the conditions of the test, not a sensitizer | Under the conditions of the study, not a sensitizer | Pass |
| Biocompatibility Skin Irritation 10993-10 | To demonstrate low skin irritation potential | Under the conditions of the test, not an irritant | Under the conditions of the study, not an irritant | Pass |
| Biocompatibility Cytotoxicity 10993-5 | To demonstrate low cytotoxicity | Under the conditions of the test, non-cytotoxic | Under the conditions of the study, non-cytotoxic | Pass |
2. Sample size used for the test set and the data provenance:
The document states criteria like "At least 29/32 pass at [value] for three non-consecutive lots" for several tests. This implies that for each of these tests, a sample size of 32 units per lot was used, and this was repeated for at least three non-consecutive lots. The data provenance is not explicitly stated in terms of country of origin or retrospective/prospective nature, as these are technical performance tests on the manufactured device itself, rather than clinical data from human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. This submission is for a surgical face mask and relies on objective, standardized laboratory performance tests according to established ASTM, Mil, and ISO standards, not expert interpretation of subjective data or images.
4. Adjudication method for the test set:
Not applicable. As noted above, the tests are objective laboratory performance measures with predefined pass/fail criteria, not subjective assessments requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This is a submission for a physical medical device (surgical face mask), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithmic or software-based device.
7. The type of ground truth used:
The ground truth for device performance is established by objective, standardized measurements against predefined values and criteria as specified in the referenced ASTM, Mil, and ISO standards (e.g., ASTM F1862 for fluid resistance, ASTM F2299 for particulate filtration efficiency, ASTM F2101 for bacterial filtration efficiency, Mil-M-36945C Appendix C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993-5 and ISO 10993-10 for biocompatibility).
8. The sample size for the training set:
Not applicable. As a physical medical device, there is no "training set" in the context of machine learning. The manufacturing process and material selection are validated through quality control and adherence to standards.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of device. The quality and performance are established through adherence to manufacturing specifications and testing against recognized industry standards.
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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 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.
November 16, 2022
KNH Surgical Face Mask % Brian Wu Specialist KNH Enterprise Co., Ltd. 1, 2, 4F., No.66-1, Sanji, Jiangjun Village, Jiangjun District, 725034 Tainan City, Taiwan
Re: K203528
Trade/Device Name: KNH Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 21, 2022 Received: October 21, 2022
Dear Brian Wu:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Bifeng Qian -S
Bifeng Qian, M.D., Ph.D. 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) K203528
Device Name KNH Surgical Face Mask
Indications for Use (Describe)
The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only.
Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 区 Over-The-Counter Use (21 CFR 801 Subpart C) |
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KNH Enterprise Co., Ltd. 27F., No.456., Sec. 4, Xinyi Rd., Xinyi Dist., Taipei, Taiwan TEL: +886-2-2345-9909 FAX: +886-2-2345-6299
Image /page/3/Picture/1 description: The image shows a logo and text related to a 510(k) summary. The logo is a red flower-like design inside a red circle, with the letters "KNH" and Chinese characters above it. Below the logo, the text "510(k) Summary" is written in a large, bold font. Underneath that, the number "K203528" is also written in a large, bold font, likely indicating a reference or identification number for the summary.
FDA 510(k) Submission: K203528
1. Type of Submission: Traditional November 11th, 2022 Date of Preparation:
- Submitter: KNH Enterprise Co., Ltd. Address: 1, 2, 4F., No.66-1, Sanji, Jiangjun Village, Jiangjun District, 725034 Tainan City, Taiwan Phone: +886-2-2345-9909 Fax: +886-2-2345-6299 Contact: Brian WU Establishment Registration Number: 3016727877
3. Identification of the Device:
| Trade Name: | KNH Surgical Face Mask |
|---|---|
| Common Name: | Surgical Masks |
| Classification Name: | Masks, Surgical |
| Device Classification: | II |
| Regulation Number: | 878.4040 |
| Classification Panel: | General & Plastic Surgery |
| Product Code: | FXX |
4. Identification of the Predicate Device:
| 510(k) Number: | K160269 |
|---|---|
| Predicate Name: | Surgical Face Masks (Ear loops and Tie-on) |
| Common Name: | Surgical Mask |
| Classification Name: | Masks, Surgical Device |
| Classification: | II |
| Regulation Number: | 878.4040 |
| Classification Panel: | General & Plastic Surgery Product |
| Code: | FXX |
-
- Indications for Use: The KNH Surgical Face Mask is intended to protect both patient and healthcare workers from the transfer of microorganisms, body fluids and particulate matter. This device is non-sterile and for single use only. Models: 1MMAB50DM2 (Level 1), 1MMAB50DM3 (Level 2)
-
- Device Description: The KNH Surgical Face Masks are four-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for singleuse only. The mask is constructed of nonwoven fabric, including the outer cover web, insertion, filter web and the inner cover web, the mask is provided with ear loops and a nose wire for individualized fit. The models
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KNH Enterprise Co., Ltd. 27F., No.456., Sec. 4, Xinyi Rd., Xinyi Dist., Taipei, Taiwan TEL: +886-2-2345-9909 FAX: +886-2-2345-6299
Image /page/4/Picture/1 description: The image shows a red logo with the letters "KNH" and Chinese characters inside a red oval. The logo also features a stylized red flower with several petals and a stem. The flower is positioned in the center of the oval, with the letters and characters arranged around it.
FDA 510(k) Submission: K203528
1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
7. Technical Comparison:
| Subject device (K203528) | Predicate (K110455) | Comparison | |
|---|---|---|---|
| Manufacturer | KNH Enterprise Co., Ltd. | San-M Package Co., Ltd. | |
| Name | KNH Surgical Face Mask | Surgical Face Masks (Ear loops andTie-on) | Similar |
| Common Name | Surgical Masks | Surgical Mask | Similar |
| Classification | II | II | Same |
| Product Code | FXX | FXX | Same |
| Indications ForUse | The KNH Surgical Face Maskis intended to protectboth patient andhealthcare workers fromthe transfer ofmicroorganisms, bodyfluids and particulatematter. This device isnon-sterile and for singleuse only.Models:1MMAB50DM2 (Level 1),1MMAB50DM3 (Level 2) | The surgical face masks are intendedto be worn to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids, and particulate material.These face masks are intended foruse in infection control practices toreduce the potential exposure toblood and body fluids. This is a single-use, disposable device, provided non-sterile.Level 1 Face Mask Models: # EL 1000,EL 10010, TO 10000, TO 10010Level 2 Face Mask Models: # EL20000, EL 20010, TO 20000, TO20010Level 3 Face Mask Models: # EL30000, EL 30010, TO 30000, TO30010 | Similar |
| ASTM F2100Level | 1 and 2 | 1, 2, and 3 | Similar topredicatelevel 1 andlevel 2maskmodels |
| Tethers | Ear loop | Ear loop, Tie-on | |
| Number ofLayers | 4 | 4 | Same |
| Outer Material | Polypropylene | Polypropylene | Similar |
| Inner Material | Polyethylene, Polypropylene | Polypropylene | Similar |
| Filter Material | 1 Polypropylene Spunbond | 1 Polypropylene spunbond | Similar |
| 2.Polypropylene Meltblown | 2. Polypropylene meltblown | ||
| Tether Material | Ear-Loops: Polyamide elasticbandEdge Wrap: PolypropyleneSpunbondNose-Wire: Polyethylene | Ear loops: Polyester, polyurethaneSide tapes: Polyester spunbond (earloops mask only)Tie tapes:Polypropylene spunbond orpolyester spunbond | Different |
| Color | Green | White or blue | Different |
| Dimensions | Length: 95± 5mmWidth: 175± 5mm | Length: 90 ± 3 mmWidth: 175 ± 5 mmOrLength: 90 ± 3 mmWidth: 180 ± 5 mm | Similar |
| Mask Style | Pleated | Pleated with optional polyester visor | Similar |
| Fluid ResistanceASTM F1862 | 80 mmHg or 120 mmHg | 80 mmHg, 120 mmHg, or 160 mmHg | Similar |
| ParticulateFiltrationEfficiencyASTM F2299 | Pass at Avg. 99.49 % (Level 1)Pass at Avg. 99.31% (Level 2) | Pass at 99.6% (Level 1)Pass at 99.6% (Level 2)Pass at 99.7% (Level 3) | Similar |
| BacterialFiltrationEfficiencyASTM F2101 | Greater than 99% (Level 1)Greater Than 99% (Level 2) | Pass at 98% Level 1Pass at 98% Level 2Pass at 99% Level 3 | Similar |
| DifferentialPressureMil M36945Appendix C | Pass at 2.5 to 2.9mmH₂O/cm²(Level 1)Pass at 2.7 to 3.7mmH₂O/cm²(Level 2) | Less than 2.0 mmH₂O/cm²Less than 1.6 mmH₂O/cm² orLess than 2.5 mmH₂O/cm² | Similar |
| Flammability16 CFR 1610 | Class 1 | Class 1 | Same |
| BiocompatibilitySkinSensitizationISO 10993-10 | Under the conditions of thestudy, not a sensitizer | Under the conditions of the study,not a sensitizer | Same |
| BiocompatibilitySkin Irritation10993-10 | Under the conditions of thestudy, not an irritant | Under the conditions of the study,not an irritant | Same |
| BiocompatibilityCytotoxicity10993-5 | Under the conditions of thestudy, non-cytotoxic | Under the conditions of the study,non-cytotoxic | Same |
| Test | Purpose | Criteria | Result |
| Fluid ResistanceASTM F1862 | To ensure adequate resistanceto fluids | 1MMAB50DM2 (Level 1): At least29/32 pass at 80 mmHg for threenon-consecutive lots | Pass |
| 1MMAB50DM3 (Level 2): At least29/32 pass at 120 mmHg for threenon-consecutive lots | Pass | ||
| ParticulateFiltrationEfficiencyASTM F2299 | To demonstrate adequateresistance to particulatetransmission | 1MMAB50DM2 (Level 1): At least29/32 pass at 95% or betterefficiency for three non-consecutivelots | Pass |
| 1MMAB50DM3 (Level 2): At least29/32 pass at 98% or betterefficiency for three non-consecutivelots | Pass | ||
| BacterialFiltrationEfficiencyASTM F2101 | To demonstrate adequateresistance to bacterialpenetration | 1MMAB50DM2 (Level 1): At least29/32 pass at 95% or betterefficiency for three non-consecutivelots | Pass |
| 1MMAB50DM3 (Level 2): At least29/32 pass at 98% or betterefficiency for three non-consecutivelots | Pass | ||
| DifferentialPressureMil M36945Appendix C | To demonstrate adequatebreathability | 1MMAB50DM2 (Level 1): At least29/32 pass at 5 mmH₂O/cm² or lessfor three non-consecutive lots | Pass |
| 1MMAB50DM3 (Level 2): At least29/32 pass at 6 mmH₂O/cm2 or lessfor three non-consecutive lots | Pass | ||
| Flammability16 CFR 1610 | To demonstrate adequateflammability resistance | At least 29/32 samples at class 1 | Pass |
| BiocompatibilitySkinSensitization | To demonstrate low skinsensitization potential | Under the conditions of the test, nota sensitizer | Pass |
| ISO 10993-10 | |||
| BiocompatibilitySkin Irritation10993-10 | To demonstrate low skinirritation potential | Under the conditions of the test, notan irritant | Pass |
| BiocompatibilityCytotoxicity10993-5 | To demonstrate low cytotoxicity | Under the conditions of the test,non-cytotoxic | Pass |
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KNH Enterprise Co., Ltd. 27F., No.456., Sec. 4, Xinyi Rd., Xinyi Dist., Taipei, Taiwan TEL: +886-2-2345-9909 FAX: +886-2-2345-6299
Image /page/5/Picture/1 description: The image shows a red logo with the letters "KNH" and Chinese characters arranged around a red flower. The flower has multiple petals and is stylized. The entire design is enclosed within a red oval border. The logo appears to be a symbol or emblem for an organization or brand.
FDA 510(k) Submission: K203528
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Image /page/6/Picture/1 description: The image is a logo for KNH, which is written in both English and Chinese. The logo is red and features a flower with several petals. The flower is inside of a red oval.
8. Non-Clinical Testing:
The proposed devices were tested and conformed to the following standards and requirements stipulated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission; including but not limited to ASTM F1862, ASTM F2101-19, Mil-M-36954C, 16 CFR 1610, ISO 10993-5, ISO 10993-10.
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KNH Enterprise Co., Ltd. 27F., No.456., Sec. 4, Xinyi Rd., Xinyi Dist., Taipei, Taiwan TEL: +886-2-2345-9909 FAX: +886-2-2345-6299
Image /page/7/Picture/1 description: The image is a red logo with the letters "KNH" stacked on top of each other on the left side. To the right of the letters are three Chinese characters. Below the letters and characters is a red flower with seven petals. The entire logo is enclosed in a red oval.
FDA 510(k) Submission: K203528
9. Clinical Testing:
No clinical testing was performed in support of this submission.
-
- Conclusion: The conclusions drawn from the non-clinical testing demonstrate the KNH Surgical Face as safe, as effective and performs as well as or better than the level 2 mask models of the predicate device K160269.
§ 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.