(172 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.
A surgical face mask is a protective barrier device, not a therapeutic device designed to treat a disease or condition.
No
The provided text describes a surgical face mask designed to protect against the transfer of microorganisms, body fluids, and particulate material. It is a filtering device meant for protection and control, not for diagnosing medical conditions or diseases.
No
The device description clearly outlines a physical product made of nonwoven materials, ear loops, and a nose piece, designed for physical filtration. There is no mention of software components or functionality.
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 (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- Device Function: The description clearly states the device is a "Surgical Face Mask" intended to be worn on the face to filter air and prevent the transfer of microorganisms and fluids. It is a physical barrier device.
- Intended Use: The intended use is for "infection control practices to reduce the potential exposure to blood and body fluids." This is a protective function, not a diagnostic testing function.
- No Biological Sample Testing: There is no mention of the device being used to test biological samples or provide diagnostic information about a patient's health status.
The device is a personal protective equipment (PPE) designed to protect both the wearer and others from the spread of airborne particles and fluids.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
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:
§ 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.
0
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.
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 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
2
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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3
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 Contact
Person: | Olivia Meng
Regulatory Affairs Manager
Guangzhou Osmunda Medical Device Technical Service
Co., Ltd.
Tel: (+86)-20-6231 6262
Fax: (+86)-20-8633 0253 |
|------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Secondary Contact
Person: | Xiangliang Cheng
Quality Manager
Zhuhai Gaoge Medical Technology Co., Ltd.
Phone: +86-0756-8803221
Fax: +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.
4
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: