(714 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate matter, which is a protective function, not a therapeutic one (treating or curing a disease).
No
This device is a surgical face mask intended to protect against microorganisms, body fluids, and particulate matter, not to diagnose a condition.
No
The device is a physical surgical face mask made of nonwoven fabric with ear loops and a nose wire. It is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use of the KNH Surgical Face Mask clearly state its purpose is to provide a physical barrier to protect against the transfer of microorganisms, body fluids, and particulate matter. It is worn externally on the face.
- Lack of Diagnostic Function: There is no mention of this device being used to analyze samples or provide diagnostic information about a patient's health status.
- Testing Performed: The testing described (fluid resistance, filtration efficiency, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask, not diagnostic performance.
Therefore, based on the provided information, the KNH Surgical Face Mask is a medical device, but it falls under a different category than In Vitro Diagnostics.
N/A
Intended Use / 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)
Product codes (comma separated list FDA assigned to the subject device)
FXX
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 1MMAB50DM2 and 1MMAB50DN3 differ in the thickness of the filter web layer.
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
patient and 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 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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance ASTM F1862: Pass
Particulate Filtration Efficiency ASTM F2299: Pass
Bacterial Filtration Efficiency ASTM F2101: Pass
Differential Pressure Mil M36945 Appendix C: Pass
Flammability 16 CFR 1610: Pass
Biocompatibility Skin Sensitization ISO 10993-10: Pass (not a sensitizer)
Biocompatibility Skin Irritation 10993-10: Pass (not an irritant)
Biocompatibility Cytotoxicity 10993-5: Pass (non-cytotoxic)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 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.
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 -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
2
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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3
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
4
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 and | |
| Tie-on) | Similar | ||
| Common Name | Surgical Masks | Surgical Mask | Similar |
| Classification | II | II | Same |
| Product Code | FXX | FXX | Same |
| 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) | 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. | |||
| Level 1 Face Mask Models: # EL 1000, | |||
| EL 10010, TO 10000, TO 10010 | |||
| Level 2 Face Mask Models: # EL | |||
| 20000, EL 20010, TO 20000, TO | |||
| 20010 | |||
| Level 3 Face Mask Models: # EL | |||
| 30000, EL 30010, TO 30000, TO | |||
| 30010 | Similar | ||
| ASTM F2100 | |||
| Level | 1 and 2 | 1, 2, and 3 | Similar to |
| predicate | |||
| level 1 and | |||
| level 2 | |||
| mask | |||
| models | |||
| Tethers | Ear loop | Ear loop, Tie-on | |
| Number of | |||
| Layers | 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 elastic | ||
| band | |||
| Edge Wrap: Polypropylene | |||
| Spunbond | |||
| Nose-Wire: Polyethylene | Ear loops: Polyester, polyurethane | ||
| Side tapes: Polyester spunbond (ear | |||
| loops mask only) | |||
| Tie tapes: | |||
| Polypropylene spunbond or | |||
| polyester spunbond | Different | ||
| Color | Green | White or blue | Different |
| Dimensions | Length: 95± 5mm | ||
| Width: 175± 5mm | Length: 90 ± 3 mm | ||
| Width: 175 ± 5 mm | |||
| Or | |||
| Length: 90 ± 3 mm | |||
| Width: 180 ± 5 mm | Similar | ||
| Mask Style | Pleated | Pleated with optional polyester visor | Similar |
| Fluid Resistance | |||
| ASTM F1862 | 80 mmHg or 120 mmHg | 80 mmHg, 120 mmHg, or 160 mmHg | Similar |
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM 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 | ||
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F2101 | Greater than 99% (Level 1) | ||
| Greater Than 99% (Level 2) | Pass at 98% Level 1 | ||
| Pass at 98% Level 2 | |||
| Pass at 99% Level 3 | Similar | ||
| Differential | |||
| Pressure | |||
| Mil M36945 | |||
| Appendix C | Pass at 2.5 to 2.9 | ||
| mmH₂O/cm² | |||
| (Level 1) | |||
| Pass at 2.7 to 3.7 | |||
| mmH₂O/cm² | |||
| (Level 2) | Less than 2.0 mmH₂O/cm² | ||
| Less than 1.6 mmH₂O/cm² or | |||
| Less than 2.5 mmH₂O/cm² | Similar | ||
| Flammability | |||
| 16 CFR 1610 | Class 1 | Class 1 | Same |
| Biocompatibility | |||
| Skin | |||
| Sensitization | |||
| ISO 10993-10 | Under the conditions of the | ||
| study, not a sensitizer | Under the conditions of the study, | ||
| not a sensitizer | Same | ||
| Biocompatibility | |||
| Skin Irritation | |||
| 10993-10 | Under the conditions of the | ||
| study, not an irritant | Under the conditions of the study, | ||
| not an irritant | Same | ||
| Biocompatibility | |||
| Cytotoxicity | |||
| 10993-5 | Under the conditions of the | ||
| study, non-cytotoxic | Under the conditions of the study, | ||
| non-cytotoxic | Same | ||
| Test | Purpose | Criteria | 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 lots | Pass | ||
| 1MMAB50DM3 (Level 2): At least | |||
| 29/32 pass at 120 mmHg for three | |||
| non-consecutive lots | 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 | |||
| lots | Pass | ||
| 1MMAB50DM3 (Level 2): At least | |||
| 29/32 pass at 98% or better | |||
| efficiency for three non-consecutive | |||
| lots | 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 | |||
| lots | Pass | ||
| 1MMAB50DM3 (Level 2): At least | |||
| 29/32 pass at 98% or better | |||
| efficiency for three non-consecutive | |||
| lots | 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 lots | Pass | ||
| 1MMAB50DM3 (Level 2): At least | |||
| 29/32 pass at 6 mmH₂O/cm2 or less | |||
| for three non-consecutive lots | Pass | ||
| Flammability | |||
| 16 CFR 1610 | To demonstrate adequate | ||
| flammability resistance | At least 29/32 samples at class 1 | Pass | |
| Biocompatibility | |||
| Skin | |||
| Sensitization | To demonstrate low skin | ||
| sensitization potential | Under the conditions of the test, not | ||
| a sensitizer | Pass | ||
| ISO 10993-10 | |||
| Biocompatibility | |||
| Skin Irritation | |||
| 10993-10 | To demonstrate low skin | ||
| irritation potential | Under the conditions of the test, not | ||
| an irritant | Pass | ||
| Biocompatibility | |||
| Cytotoxicity | |||
| 10993-5 | 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
6
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.
7
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.