(278 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 described as a surgical face mask intended to protect from microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines physical components (spunbond polypropylene, melt blown polypropylene filter, mask belt, nose clip) and the performance studies focus on physical properties and filtration efficiency, not software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose clip). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, fluid resistance, breathability, flammability, biocompatibility). These are relevant to a protective device, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This surgical face mask does not perform such a function.
N/A
Intended Use / Indications for Use
The surgical face masks (Ear loops) 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.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.
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
Not Found
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)
The following nonclinical testing was performed to demonstrate the subject device conform to the standard or test methodology:
- Level ASTM F2100-19: Purpose To define the performances of the medical face mask. Acceptance Criteria: Level 1. Results: Level 1.
- Resistance to penetration by systhetic blood ASTM F1862: Purpose To evaluate the resistance of medical face masks to penetration by the impact of a small volume of high-velocity stream of synthetic blood. Medical face mask pass/fail determinations are based on visual detection of synthetic blood penetration. Acceptance Criteria: Minimum 80mmHg. Results: Pass at 80mmHg.
- Particulate Filtration Efficiency ASTM F2299: Purpose To measure the initial particle filtratioon efficiency of materials used in medical face mask using monodispersed polystyrene latex sphere aerosols. Acceptance Criteria: >=95%. Results: Pass at 98.33%.
- BFE ASTM F2101: Purpose To measure the bacterial filtration efficiency (BFE) of medical face mask materials, employing a ratio of the upstream bacterial challenge to downstream residual concentration to determine filtration efficiency of medical face mask materials. Acceptance Criteria: >=95%. Results: Pass at 99.99%.
- Differential Pressure EN 14683:2019+AC:2019 AnnexC: Purpose To determine the breathability of medical face mask by measuring the differential air pressure with the airflow direction from the inside of the mask to the outside of the mask. Acceptance Criteria:
§ 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 2, 2021
Guangdong Lide Medical Technology Co., Ltd. % Ying Hou Consultant Microkn Business Consulting (Shanghai) Co., Ltd Room 1215, Block A, No 3699, Gonghexin Road, Jingan District Shanghai. 200435 China
Re: K210222
Trade/Device Name: Disposable Medical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: September 5, 2021 Received: September 22, 2021
Dear Ying Hou:
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.
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
1
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 Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210222
Device Name Disposable Medical Mask
Indications for Use (Describe)
The surgical face masks (Ear loops) 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.
Type of Use (Select one or both, as applicable)
| ✘ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| □ Over-The-Counter Use (21 CER 801 Subpart C) |
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510K Summary
According to the requirements Per 21 CFR §807.92:
| Company: | Guangdong Lide Medical Technology Co.,Ltd. |
|---|---|
| Address: | HFDB-05-2102 Ecological Technology City, West Side of Haizi Road, |
| Chengdong Town, Haifeng County, Shanwei City516400, Guangdong | |
| Province, China | |
| Contact Person: | Zhuang Shenglin |
| Telephone: 18664514268 | |
| E-mail: 158953590@qq.com | |
| Common Name | Disposable Medical Mask |
| Classification | |
| Name: | 21 CFR 878.4040 |
| Legal | |
| Manufacturer: | Guangdong Lide Medical Technology Co.,Ltd. |
| HFDB-05-2102 Ecological Technology City, West Side of Haizi Road, | |
| Chengdong Town, Haifeng County, Shanwei City516400, Guangdong | |
| Province, China | |
| Predicate Device | |
| Predicate Device: | Surgical Face Masks (Ear loops and Tie-on) |
| 510(k) Number: | K160269 |
| Consultant | |
| Company | Microkn Business Consulting (Shanghai) Co., Ltd. |
| Address | Room 1219, Block A, No 3699, Gonghexin Road, Jingan District, |
| Shanghai, China | |
| Contact Person | Yuling Chen |
| Telephone | +86 15021397762 |
| Yuling.chen@microkn.com |
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1. Indications for use
The surgical face masks (Ear loops) 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.
2. Description of the Device
The Surgical Face Mask are Non-sterile, single use, 3 layers, flat-pleated style with mask belt and nose clip. The outer layer and inner facing layer of face mask consist of spunbond polypropylene, and the middle layer consists of melt blown polypropylene filter. Each mask contains mask belt to secure the mask over the user's face and mouth with nose clip to firmly fit over the nose. This device is not made from any natural rubber latex.The structure of this device is illustrated by figure . 1
Image /page/4/Figure/4 description: The image shows a technical drawing of a face mask. The drawing includes two views of the mask, one from the front and one in perspective. The front view shows the length (L) and height (H) of the mask. The perspective view shows the different layers of the mask, including the spunbond layer, melt spraying layer, and nose clip. The mask belt is also labeled.
Figure. 1 Structure
3. Sizes of the product
The sizes of the product shown in Table 1.
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Table 1 The sizes of the product
| Model | Size (mm) | layers | |
|---|---|---|---|
| Length(L) | Width(H) | ||
| Earloop style | |||
| 175×95 | $175\pm5%$ | $95\pm5%$ | 3 |
4. Components
The main components of proposed device are shown in Table 2.
| Components | Function Description | Applied Model(s) |
|---|---|---|
| Outer Spunbond layer | Block water and prevent droplets from entering the mask | All Models |
| Components | Function Description | Applied Model(s) |
| Meltblown layer | Filter | All Models |
| Inner Spunbond layer | moisture absorption | All Models |
| Nose clip | fixed geometry | All Models |
| Mask belt | secure the mask over the user's face and mouth | All Models |
Table 2 Main Components of Proposed Device
5. Technological Characteristics Comparison to Predicate Device
| Feature | Proposed Device | Predicate device | |
|---|---|---|---|
| 510(K)# | K210222 | K160269 (EL 10000) | |
| Level | Level 1 | Level 1 | |
| Manufacturer | Guangdong Lide Medical | ||
| Technology Co.,Ltd. | San-M Package Co., | ||
| Ltd. | |||
| Common Name | Surgical Mask | Surgical Mask | |
| Classification | Class II | Class II | |
| Product Code | FXX | FXX | |
| Feature | Proposed Device | Predicate device | |
| Intended 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, provided non-sterile. | 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 devices are intended for use in infection control practices to reduce the patient exposure to blood and body fluids. This is a single-use, disposable device, provided non-sterile. | |
| Materials | |||
| Outer Material | Polypropylene | Polypropylene | |
| Inner Material | Polypropylene spunbond | ||
| Polypropylene meltblown | Polypropylene spunbond | ||
| Polypropylene meltblown | |||
| Ear Loops/mask belt | Nylon and Spandex | Polyester, polyuretha ne, polyester spunbond | |
| Colorant | White (Inner) and blue (Outer side) | White (Inner) and blue (Outer side) | |
| Specifications | Length:175mm±5mm | ||
| Width:95mm±5mm | Length:90±3mm | ||
| Length:90+3mm | |||
| Feature | Proposed Device | Predicate device | |
| Width:17 | |||
| 5±5mm | Width:18 | ||
| 5mm | |||
| Mask Style | Flat-pleated | Flat-pleated | |
| Sterility | Non-sterile | No- sterilization | |
| Performance | |||
| Testing | |||
| (ASTM F2100-19) | Level 1 | Level 1 | |
| BFE | Pass at 99.99% | Pass at 99.6% | |
| Particulate | |||
| Filtratin | |||
| Efficiency | Pass at 98.33 | Pass at >98% | |
| Differential | |||
| Pressure | Pass at 4.1 mmH2O/cm2 | Pass at 2.0 mmH2O/cm2 | |
| Resistance to | |||
| penetration by | |||
| blood | Pass at 80mmHg | Pass at 80mmHg | |
| Flammability | Class 1 | Class 1 | |
| Biocompatibility | |||
| Contact Category | Skin | Skin | |
| Biocompatibility | |||
| Contact Duration | Prolong | Prolong | |
| Shelf life | 1 year | Unavailable from | |
| public information | |||
| (Difference 1) |
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Difference 1: Real-time aging testing was carried out to decide the shelf life of the proposed surgical mask. Testing results demonstrated that the life of the surgical mask is 1 years. The difference will not generate negative affect for the safety and performance of the device used following the IFU.
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6. Summary of Non-Clinical Test Data
The following nonclinical testing was performed to demonstrate the subject device conform to the standard or test methodology found in the summary table below. The results demonstrate the subject device met the acceptance criteria or specifications described below.
6.1 Animal Study
None
6.2 Performance Study
| Test Methodology | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Level | |||
| ASTM F2100-19 | To define the | ||
| performances of the | |||
| medical face mask | Level 1 | Level 1 | |
| Resistance to | |||
| penetration by | |||
| systhetic blood | |||
| ASTM F1862 | To evaluate the resistance | ||
| of medical face masks to | |||
| penetration by the impact | |||
| of a small volume of | |||
| high-velocity stream of | |||
| synthetic blood. Medical | |||
| face mask pass/fail | |||
| determinations are based | |||
| on visual detection of | |||
| synthetic blood | |||
| penetration. | Minimum 80mmHg | Pass at 80mmHg | |
| Particulate Filtration | |||
| Efficiency | |||
| ASTM F2299 | To measure the initial | ||
| particle filtratioon | |||
| efficiency of materials | |||
| used in medical face | |||
| mask using | |||
| monodispersed | |||
| polystyrene latex sphere | |||
| aerosols. | ≥95% | Pass at 98.33% | |
| BFE ASTM F2101 | To measure the bacterial | ||
| filtration efficiency | |||
| (BFE) of medical face | |||
| mask materials, | |||
| employing a ratio of the | |||
| upstream bacterial | |||
| challenge to downstream | |||
| residual concentration to | ≥95% | Pass at 99.99% | |
| Test Methodology | Purpose | Acceptance Criteria | Results |
| determine filtration | |||
| efficiency of medical face | |||
| mask materials | |||
| Differential Pressure | |||
| EN | |||
| 14683:2019+AC:2019 | |||
| AnnexC | To determine the | ||
| breathability of medical | |||
| face mask by measuring | |||
| the differential air | |||
| pressure with the airflow | |||
| direction from the inside | |||
| of the mask to the outside | |||
| of the mask. |