(235 days)
Single-use medical face 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.
The proposed device is single-use medical face mask. It is non-sterile and for single use. The single-use medical face mask is manufactured with three-layers, the inner and outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip. It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
This document is a 510(k) summary for a Single-use medical face mask. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance testing.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Item | Test Methods | Reported Device Performance | Acceptance Criteria |
|---|---|---|---|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19 / ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron (%) | ASTM F2100-19 / ASTM F2299 / ASTM F2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19 / ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-19 / 16 CFR Part 1610-2019 | NA (result implicit Class 1) | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19 / EN 14683:2019+AC:2019(E) Annex C | Average 2.44 | Level 1: <5.0 |
| Cytotoxicity (ISO 10993-5) | ISO 10993-5: 2009 | Non-cytotoxic | Non-cytotoxic |
| Sensitization (ISO 10993-10) | ISO 10993-10:2010 | Non-sensitizing | Non-sensitizing |
| Irritation (ISO 10993-10) | ISO 10993-10:2010 | Non-irritating | Non-irritating |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for each performance test. It only mentions that "Performance testing was conducted on the single-use medical face mask." The data provenance is North America (as per ASTM standards), but the manufacturing country is China. The study is a non-clinical, retrospective study based on laboratory testing of the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is established through standardized laboratory testing (e.g., ASTM standards) rather than expert consensus on images or clinical cases. The "experts" would be the certified laboratories performing these specific biomechanical/material tests, adhering to the outlined standards. Their qualifications are inherent in their accreditation to perform such tests.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements against defined standards, not subjective assessments requiring 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 medical face mask, not an AI-powered diagnostic device. No human reader or AI comparative effectiveness study was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device (face mask), not an algorithm.
7. The type of ground truth used
The ground truth used is based on standardized test methods and predefined quantitative acceptance criteria from regulatory and industry standards such as ASTM F2100-19, ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR Part 1610, EN 14683:2019+AC:2019(E) Annex C, and ISO 10993 for biocompatibility.
8. The sample size for the training set
Not applicable. This is a physical medical device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for a physical medical device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
March 7, 2021
Guangdong Horigen Mother & Baby Products Co., Ltd % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co.,Ltd. 8-9th Floor, R&D Building, No.26 Oinglan Street Panyu District Guangzhou, Guangdong 510006 China
Re: K201974
Trade/Device Name: Single-use medical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: January 29, 2021 Received: February 1, 2021
Dear Olivia Meng:
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 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.
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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Indications for Use
510(k) Number (if known) K201974
Device Name Single-use medical face mask
Indications for Use (Describe)
Single-use medical face 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.
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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Image /page/3/Picture/0 description: The image shows the logo for HORIGEN. The logo features a red square with rounded corners. Inside the square, there is a white crescent shape with a profile of a face within it. Below the square, the word "HORIGEN" is written in a serif font, with the letters in a light red color.
510(k) Summary
1. SUBMITTER
Guangdong Horigen Mother & Baby Products Co., Ltd. No. 18, Pingnan Industrial Zone, Mianbei Street, Chaoyang District, 515100 Shantou, Guangdong, China Phone: +86-754-83613668 Fax: +86-754-83843338
| Primary Contact | Olivia Meng |
|---|---|
| Person: | Regulatory Affairs Manager |
| Guangzhou Osmunda Medical Device Technical ServiceCo., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86) -20-8633 0253 | |
| Secondary Contact | Changxin Chen |
| Person: | General Manager Assistant |
| Guangdong Horigen Mother & Baby Products Co., Ltd. | |
| Tel: (+86)-754-83613668-866 | |
| Fax: (+86)-754-83843338 | |
| Date prepared | March 6, 2021 |
| 2. DEVICE | |
| 510K number | K201974 |
| Device Name: | Single Use Medical Face Mask |
| Device Name: | Single-Use Medical Face Mask |
|---|---|
| Common name: | Surgical Face Mask |
| Model: | KZ-170A |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
3. PREDICATE DEVICE
K153409, Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
DEVICE DESCRIPTION 4.
The proposed device is single-use medical face mask. It is non-sterile and for single use.
The single-use medical face mask is manufactured with three-layers, the inner and
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Image /page/4/Picture/0 description: The image features a logo with a red square background. Inside the square is a white crescent shape with a profile of a face looking towards the right. Below the square, the word "HORIGEN" is written in a red, serif font.
outer layers are made of spun-bond polyethylene, and the middle layer is made of melt blown Polyethylene. The elastic ear loop of proposed device is made of spandex and polyester, not natural rubber latex. The nose piece contained in the proposed device allows the user to fit the face mask around their nose, which is made from zinc strip.
It is a self-inhalation filter mask, which works by filtering the air through the filter material of the mask before being inhaled or exhaled.
5. Indications for use
The single-use medical face 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
| Subject Device | Predicate Device | ComparisonResult | |
|---|---|---|---|
| Manufacturer | Guangdong Horigen Mother& Baby Products Co., Ltd. | Protect U Guard, LLC | NA |
| 510K Number | K201974 | K153409 | NA |
| Product CommonName | Single-Use Medical FaceMask | Protect U Guard Earloop and Tie-On Mask (Blue, White or Green) | NA |
| Intended Use | Single-Use Medical FaceMask is intended for use byhealthcare workers duringprocedures to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, bodilyfluids, and particulatematerials. This device issingle-use and providednon-sterile. | Earloop Mask and Tie-OnMask is intended for use byhealthcare workers duringprocedures to protect bothpatients and healthcareworkers against transfer ofmicroorganisms, bodilyfluids, and airborneparticles. This device issingle-use and providednon-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop | Earloop or tie-on | Similar |
| Material of outerfacing layer | Spun-bond polyethylene | Spunbound polypropylene | Similar |
| Materialofmiddle layer | Melt blown Polyethylene | Melt blown polypropylene | Similar |
| Material of innerfacing layer | Spun-bond polyethylene | Spunbound polypropylene | Similar |
| Nose piece | Malleable polyethylene wirewith zinc inside | Aluminum strip | Similar |
| Attachment | Ear loops: Spandex andpolyester | Urethane elastic fiberearloop or spunboundpolypropylene tie | Similar |
| Dimension(Length × Width) | 17.5 cm × 9.5 cm | 17.7 cm × 9.5 cm | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100level | Level 1 | Level 1 | Same |
| Resistance toPenetration bysynthetic blood | 80 mmHg | 80 mmHg | Same |
| Sub-MicronParticle FiltrationEfficiency | Average 99.8% at 0.1micron | 99.18% at 0.1 micron | Similar |
| BacterialFiltrationEfficiency | Average 99.9% | Average 99.17% | Similar |
| Flammabilityclass | 1 | 1 | Same |
| DifferentialPressure | Average 2.44 mm H2O/cm2 | Average 3.79 mmH2O/cm2 | Similar |
| Biocompatibility | |||
| CytotoxicityISO 10993-5 | Under the conditions of thestudy, the device was foundnon-cytotoxic. | Under the conditions of thestudy, the device was foundnon-cytotoxic. | Same |
| SensitizationISO 10993-10 | Under the conditions of thestudy, the device was foundnon-sensitizing. | Under the conditions of thestudy, the device was foundnon-sensitizing. | Same |
| IrritationISO 10993-10 | Under the conditions of thestudy, the device was foundnon-irritating. | Under the conditions of thestudy, the device was foundnon-irritating. | Same |
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Image /page/5/Picture/0 description: The image features a logo for "HORIGEN". The logo consists of a red square with rounded corners. Inside the square, there is a white crescent shape with a silhouette of two faces looking at each other. Below the square, the word "HORIGEN" is written in a serif font, also in red.
The subject device is the same as the predicate device in the intended use, mask style, ASTM F2100 level and biocompatibility, and similar in materials and dimension. So the subject device is identical to the predicate device.
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS 7.
- 7.1. Non-clinical test performed on the proposed device
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Image /page/6/Picture/0 description: The image shows the logo for HORIGEN. The logo features a red square with rounded corners. Inside the square is a white crescent shape with a profile of a face within it. Below the square, the word "HORIGEN" is written in a sans-serif font.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
The biocompatibility evaluation for the single-use medical face mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests:
- Cytotoxicity - (ISO 10993-5: 2009)
- Sensitization - (ISO 10993-10:2010)
- Skin Irritation - (ISO 10993-10:2010)
Performance testing
Performance testing was conducted on the single-use medical face mask. All of the tested parameters met the predefined acceptance criteria.
| Item | Test Methods | Result value | Acceptance criteria |
|---|---|---|---|
| Resistance to Penetration by synthetic blood (mmHg) | ASTM F2100-19ASTM F1862/ASTM F1862-2017 | 80 | Level 1: 80 |
| Sub-Micron Particulate Filtration Efficiency (PFE) at 0.1 micron Test (%) | ASTM F2100-19ASTM F2299 /ASTMF2299-2003(2017) | Average 99.8% | Level 1: ≥95% |
| Bacterial Filtration Efficiency Test (BFE), % | ASTM F2100-19ASTM F2101-19 | Average 99.9% | Level 1: ≥95% |
| Flammability | ASTM F2100-1916 CFR Part 1610-2019 | NA | Class 1 |
| Differential Pressure Test mm H₂O/cm² | ASTM F2100-19EN 14683:2019+AC:2019(E)Annex C | Average 2.44 | Level 1: <5.0 |
7.2. Clinical test
No clinical testing was performed.
-
- CONCLUSION
- 8.1. Clinical test conclusion
No clinical study is included in this submission.
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Image /page/7/Picture/0 description: The image shows the logo for HORIGEN. The logo is a red square with rounded corners. Inside the square is a white image of two faces in profile, facing each other. Below the square is the word "HORIGEN" in a sans-serif font.
8.2. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201974, the single-use medical face mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.
§ 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.