(172 days)
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(s), provided non-sterile.
The Surgical Face Mask is designed and manufactured by Zhuhai Gaoge Medical Technology Co., Ltd. It is non-sterile and for single use. The Surgical Face Mask has one model, GK103, that is the ear-loop style. It is made of three-layer nonwovens, ear loops and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The ear loops are made of polyester. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of iron wire wrapped with plastic. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.
This is a 510(k) summary for a Surgical Face Mask (Model GK103). The document demonstrates substantial equivalence to a predicate device (K153496, Disposable Surgical Face Mask).
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Test Item & Test Methods | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Flammability (ASTM F2100-19, 16 CFR 1610-2008) | Class 1 (ASTM F2100) | Pass (Class 1, Non-Flammable) |
| Bacterial Filtration Efficiency (BFE) (ASTM F2100-2019 9.1, ASTM F2101-2019) | Level 2: ≥ 98% (ASTM F2100) | Pass (average at 99.9%) |
| Differential Pressure (Delta P) (ASTM F2100-19 9.2) | Level 2: < 6.0 mm H2O/cm² (ASTM F2100) | Pass (average at 3.7 mm H2O/cm²) |
| Sub-Micron Particle Filtration Efficiency (ASTM F2100-2019 9.3, ASTM F2299/F2299M-2017) | Level 2: ≥ 98% (ASTM F2100) | Pass (average at 98.76%) |
| Resistance to Penetration by Synthetic Blood (ASTM F2100-2019 9.4, ASTM F1862/F1862-2017) | Level 2: pass at 120 mmHg (ASTM F2100) | Pass (32 out of 32 pass at 120 mmHg) |
Regarding Biocompatibility (ISO 10993-1:2018):
- Cytotoxicity: Not cytotoxicity effect.
- Sensitization: Not a sensitizer.
- Irritation: Not an irritant.
2. Sample size used for the test set and the data provenance
The document states for the performance tests (BFE, Differential Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by Synthetic Blood, Flammability) that the tests were conducted "For 3 non-consecutive lots, 32 out of 32 pass". This implies a sample size of 32 units per lot for a total of 96 units across three lots for these specific tests.
The data provenance is not explicitly stated in terms of country of origin of the data or being retrospective/prospective. However, given that the manufacturer is Zhuhai Gaoge Medical Technology Co., Ltd. in China, it is reasonable to assume the testing was conducted in China or conducted by a laboratory in accordance with international standards. These are prospective tests performed specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes the performance testing of a physical medical device (a surgical face mask) against established industry standards (e.g., ASTM F2100, ISO 10993). Ground truth in this context is established by the measurement instruments and methodologies defined by these standards, not by expert consensus or interpretation of medical images/data. Therefore, there are no "experts" establishing a ground truth in the way one would for diagnostic AI. The results are objective measurements from laboratory tests.
4. Adjudication method for the test set
Not applicable. As described above, the "ground truth" is determined by objective physical and chemical testing methods according to recognized standards, not by human adjudication of ambiguous cases.
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/Software as a Medical Device (SaMD) that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a submission for a physical medical device (surgical face mask), not an AI/Software as a Medical Device (SaMD).
7. The type of ground truth used
The ground truth used for establishing the device's performance is based on objective measurements from laboratory testing according to recognized industry standards (e.g., ASTM F2100 for performance criteria, ISO 10993 for biocompatibility).
8. The sample size for the training set
Not applicable. This device is a physical surgical face mask, not an AI/Software as a Medical Device (SaMD) that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is a physical surgical face mask, not an AI/Software as a Medical Device (SaMD).
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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.
June 11, 2021
Zhuhai Gaoge Medical Technology Co., Ltd. % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No. 26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K203732
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: April 25, 2021 Received: April 30, 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,
Clarence W. Murray, III, 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) K203732
Device Name Surgical Face Mask
Indications for Use (Describe)
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(s), 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 contains the logo for "Gaoge". The logo consists of a blue hexagon-like shape with a white "G" inside, followed by the word "Gaoge" in a bold, sans-serif font. The color of the text is black. The logo appears to be for a company or organization named "Gaoge".
510(k) Summary K203732
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Zhuhai Gaoge Medical Technology Co., Ltd. 3rd floor, flat 5, No. 6 JinYuan one street, TangliaWan town, Zhuahai National Hi-tech industrial development zone, Zhuhai city, Guangdong province, China Phone: +86-0756-8803221 Fax: +86-0756-8307281
| Primary ContactPerson: | Olivia MengRegulatory Affairs ManagerGuangzhou Osmunda Medical Device Technical ServiceCo., Ltd.Tel: (+86)-20-6231 6262Fax: (+86)-20-8633 0253 |
|---|---|
| Secondary ContactPerson: | Xiangliang ChengQuality ManagerZhuhai Gaoge Medical Technology Co., Ltd.Phone: +86-0756-8803221Fax: +86-0756-8307281 |
| Date prepared | Apr 25th , 2021 |
| 2. | DEVICE |
| Device Name: | Surgical Face Mask |
| Common name: | Mask, Surgical |
| Model: | GK103 |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
PREDICATE DEVICE ന്
K153496, Disposable Surgical Face Mask
This predicate has not been subject to a design-related recall.
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Image /page/4/Picture/0 description: The image contains the logo for Gaoge. The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black font. The logo is simple and modern, and the colors are eye-catching.
4. DEVICE DESCRIPTION
The Surgical Face Mask is designed and manufactured by Zhuhai Gaoge Medical Technology Co., Ltd. It is non-sterile and for single use.
The Surgical Face Mask has one model, GK103, that is the ear-loop style. It is made of three-layer nonwovens, ear loops and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The ear loops are made of polyester. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of iron wire wrapped with plastic.
It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- . Bacterial filtration efficiency (BFE) ≥ 98%
- . Sub-micron particle filtration efficiency ≥ 98%
- . Different pressure: < 6.0 mm H2O/cm2
- " Flammability: class 1
- . Resistance to penetration by synthetic blood: 120 mmHg
5. 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(s), provided non-sterile.
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Image /page/5/Picture/0 description: The image contains a logo with the word "Gaoge" in a bold, sans-serif font. To the left of the word is a blue, geometric shape that resembles a cube with a "G" cut out of it. The cube is made up of several smaller, triangular shapes that give it a three-dimensional appearance. The overall design is modern and professional.
6. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
| Item | Proposed device | Predicate device | Comparisonresult |
|---|---|---|---|
| Manufacturer | Zhuhai Gaoge Medical TechnologyCo., Ltd. | Xiantao Rayxin Medical ProductsCo., Ltd. | NA |
| 510K Number | K203732 | K153496 | NA |
| Product CommonName | Surgical Face Mask | Disposable Surgical Face Mask | NA |
| Intended Use | The Surgical Face Masks areintended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. These facemasks are intended for use ininfection control practices toreduce the potential exposure toblood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | The Disposable Surgical FaceMasks are intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intended foruse in infection control practicesto reduce the potential exposureto blood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Ear loop, 3 layers | Ear Loops, Tie-On, 3 layers | Similar |
| Material of outerfacing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Material of middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Material of innerfacing layer | Spun-bond Polypropylene | Spun-bond Polypropylene | Same |
| Nose piece | Galvanized iron wire wrappedwith polyethylene(PE) | Malleable aluminum wire | Similar |
| Attachment | Ear loops: Polyester | Ear loops: PolyesterTieon: Spun-bond Polypropylene | Similar |
| Color | Blue | Blue | Same |
| Dimension (Length× Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.5 cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100 level | Level 2 | Level 2 | Same |
| Fluid Resistance | For 3 non-consecutive lots. | 32 out of 32 pass | Same |
| Performance | 32 out of 32 pass | at 120 mmHg | |
| ASTM F1862 | at 120 mmHg | ||
| ParticulateFiltrationEfficiency ASTMF2299 | For 3 non-consecutive lots,32 out of 32 pass,average at 98.76% | 98.46% | Similar |
| BacterialFiltrationEfficiency ASTMF2101 | For 3 non-consecutive lots,32 out of 32 pass,average at 99.9% | 98.7% | Similar |
| DifferentialPressure (DeltaP) ASTMF2100 | For 3 non-consecutive lots,32 out of 32 pass,average at 3.7 $mmH_2O/cm^2$ | 4.2 $mmH_2O/cm^2$ | Similar |
| Flammability 16CFR 1610 | For 3 non-consecutive lots,32 out of 32 pass,Class 1Non-Flammable | Class 1Non-Flammable | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, not cytotoxicity effect | Under the conditions of thestudy, not cytotoxicity effect | Same |
| Irritation | Under the conditions of thestudy, not an irritant | Under the conditions of thestudy, not an irritant | Same |
| Sensitization | Under conditions of the study,not a sensitizer | Under conditions of the study,not a sensitizer | Same |
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Image /page/6/Picture/0 description: The image contains the logo for Gaoge. The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black font. The hexagon is a gradient of blue, with the top being a lighter blue and the bottom being a darker blue.
The proposed Surgical Face Mask and the predicate device is identical in the intended use, mask style, design feature, color, ASTM F2100 level and biocompatibility, and similar only in ear loops' material. So the proposed device is identical to the predicate device.
7. PERFORMANCE DATA
The following performance data were provided to demonstrate that the subject device met the acceptance criteria of the test method or standard.
Biocompatibility testing
The biocompatibility evaluation for the Surgical Face Mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical
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Image /page/7/Picture/0 description: The image contains the logo for "Gaoge". The logo consists of a blue hexagon with a white "G" inside of it, followed by the word "Gaoge" in black, sans-serif font. The logo is simple and modern, and the colors are eye-catching.
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 Surgical Face Mask. All of the tested parameters met the predefined acceptance criteria.
| Test item & Test Methods | Test purpose | Acceptancecriteria | Results |
|---|---|---|---|
| FlammabilityASTM F2100-1916 CFR Part 1610-2008 | Testing the characteristics ofa material that pertain to itsrelative ease of ignition andrelative ability to sustain combustion. | Class 1ASTM F2100 | Pass |
| Bacterial Filtration EfficiencyASTM F2100-2019 9.1ASTM F2101-2019 | Testing the effectiveness ofmedical face mask materialin preventing the passage ofaerosolized bacteria. | Level 2: ≥ 98%ASTM F2100 | Pass |
| Different Pressure, mm H2O/cm²ASTM F2100-19 9.2 | Measuring the pressure ofdropping across a medicalface mask material. | Level 2: < 6.0ASTM F2100 | Pass |
| Sub-Micron Particle FiltrationEfficiencyASTM F2100-2019 9.3ASTM F2299/F2299M-2017 | Testing the efficiency of thefilter material in capturingaerosolized particles smallerthan one micron. | Level 2: ≥ 98%ASTM F2100 | Pass |
| Resistance to Penetration bysynthetic bloodASTM F2100-2019 9.4ASTM F1862/F1862-2017 | Testing the efficiency ofresistance to penetration bysynthetic blood. | Level 2: pass at120 mmHgASTM F2100 | Pass |
8. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe,
as effective, and performs as well as or better than the legally marketed device.
§ 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.