(114 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No
The surgical face mask is primarily intended to "protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials," which is a protective function, not a therapeutic one. It does not treat or cure a disease or condition.
No
This device is a surgical face mask, designed to protect against the transfer of microorganisms and particulate materials. It does not perform any diagnostic function.
No
The device description clearly outlines physical components made of materials like polypropylene, nylon, spandex, and iron wire, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: 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. They are used outside of the body (in vitro) to provide information about a person's health.
- Intended Use: The intended use of this surgical face mask is to protect against the transfer of microorganisms, blood, body fluids, and particulate materials. This is a barrier function, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components of a mask designed for physical protection, not for analyzing biological samples.
- Lack of Diagnostic Function: There is no mention of any component or function that would involve testing or analyzing a sample from a patient. The performance metrics listed (filtration efficiency, fluid resistance, etc.) relate to the mask's ability to act as a physical barrier.
This device is a personal protective equipment (PPE) designed to prevent the spread of contaminants, not to diagnose a condition.
N/A
Intended Use / Indications for Use
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The proposed device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The ear loops, which are made of nylon and spandex, are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
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
operating room personnel and other general 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 tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
- ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization;
- ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
- ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
- ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
- ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
- ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
- 16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
- EN 14683: 2019 Medical face masks- Requirements and test methods
- ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance: Pass at 120mmHg
- Particulate filtration efficiency: Average 98.74% at 0.1µm
- Bacterial filtration efficiency: Average 99.65%
- Differential pressure: Average 4.6mmH2O/cm²
- Flammability: Class 1
- Cytotoxicity: No Cytotoxicity
- Sensitization: No Sensitization
- Irritation: No Irritation
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 21, 2021
Jiangxi Feilikang Medical Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box. 120-119 Shanghai, 200120 China
Re: K202904
Trade/Device Name: Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 23, 2020 Received: September 29, 2020
Dear Diana Hong:
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 and Part 809); 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 (OS) 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.
For CAPT Elizabeth Claverie, M.S. 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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name Surgical Face Mask
Indications for Use (Describe)
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
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
510(k) Summary
This 510(k) Summary is being submitted in accordance with requirements of Title 21, CFR Section 807.92.
The assigned 510(k) Number:
-
- Date of Preparation: 01/15/2021
-
- Sponsor Identification
Jiangxi Feilikang Medical Technology Co., Ltd. Building 8, Anyuan Electronic Industry Park, Pingxiang City, Jiangxi Province, China.
Establishment Registration Number: 3017247636.
Contact Person: Shijun Zhang Position: Chairman Tel: +86-799-2181 777 Email: Keller@midbluegroup.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd.
P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1-360-925-3199 Email: info@mid-link.net
4
-
- Identification of Proposed Device Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Size: 17.5cm×9.5cm
Regulatory Information Classification Name: Mask, Surgical Classification: II; Product Code: FXX; Regulation Number: 21CFR 878.4040 Review Panel: General Hospital
- Identification of Proposed Device Trade Name: Surgical Face Mask Common Name: Surgical Face Mask Size: 17.5cm×9.5cm
Indication for use:
Surgical Face Mask is intended for single use by operating room personnel and other general healthcare workers to protect both patients and healthcare workers against transfer of microorganisms, blood and body fluids, and particulate materials.
Device Description:
The proposed device is a three-layer, single-use, flat-pleated mask. The inner and outer layers of the mask are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt-blown fabric. The ear loops, which are made of nylon and spandex, are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The nose clip is to allow the user to fit the facemask around their nose, which is made of polypropylene and iron wire.
-
- Identification of Predicate Devices
Predicate Device 510(k) Number: K173062 Product Name: Non-Woven Face Mask
- Identification of Predicate Devices
6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards:
-
ISO 10993-5:2009 Biological evaluation of medical device- Part 5: Tests for in vitro cytotoxicity;
-
ISO 10993-10:2010 Biological evaluation of medical device- Part 10: Tests for irritaion and skin sensitization;
5
- A ASTM F1886/F1886M-16 Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection;
-
ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration;
- A ASTM F88/F88M-15 Standard Test Method for Seal Strength of Flexible Barrier Materials;
-
ASTM F2299/F2299M-03 (2017) Standard Test Method for Determining the Initial Efficiency of Material Used in medical Face Masks to Penetration by Particulates using Latex Spheres;
-
ASTM F2101-2019 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus;
- A ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity);
-
16 CFR Part 1610 Standard for the Flammability of Clothing Textiles;
-
EN 14683: 2019 Medical face masks- Requirements and test methods
-
ISO 10993-7:2008 Biological Evaluation of Medical Device- Part 7: Ethylene Oxide Sterilization Residuals
-
- Clinical Test Conclusion
No clinical study is included in this submission.
6
-
- Summary of Technological characteristics
| ITEM | Proposed Device K202904 | Predicate Device K173062 | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Indication for Use | Surgical Face Mask is intended | ||
| for single use by operating room | |||
| personnel and other general | |||
| healthcare workers to protect both | |||
| patients and healthcare workers | |||
| against transfer of | |||
| microorganisms, blood and body | |||
| fluids, and particulate materials. | Non-Woven Face Mask (Models: | ||
| VQN0185W (ear loop) and | |||
| VQN0185B (ties)) is intended for | |||
| single use by operating room | |||
| personnel and other general | |||
| healthcare workers to protect both | |||
| patients and healthcare workers | |||
| against transfer of microorganisms, | |||
| blood and body fluids, and | |||
| particulate materials. | Same | ||
| Mask style | Flat-pleated, 3 layers | Flat-pleated, 3 layers | Same |
| Design feature | Ear loop | Ear loop/Tie-on | Different |
| Color | Blue | Blue | Same |
| Dimension | Mask Body:17.5cm×9.5cm | ||
| Nose Clip: 10.5cm | |||
| Ear Loop: 17cm | Mask Body:17.5cm×9.5cm | ||
| Nose Clip: Unknown | |||
| Ear Loop: Unknown | Similar | ||
| ASTM | |||
| F2100 | |||
| Level | Level 2 | Level 2 | Same |
| Sterilization | Sterile | Non-Sterile | Different |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Fluid resistance | Pass at 120mmHg | Pass at 120mmHg | Same |
| Particulate | |||
| filtration efficiency | Average 98.74% at 0.1µm | Average 99.74% at 0.1µm | Different |
| Bacterial filtration | |||
| efficiency | Average 99.65% | Average 99.4% | Different |
| Differential | |||
| pressure | Average 4.6mmH2O/cm² | Average 2.7mmH2O/cm² | Different |
| Flammability | Class 1 | Class 1 | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Patient Contacting Material | |||
| Outer facing layer | Polypropylene Non-Woven Fabric | Spun-bond polypropylene | Different |
| Middle layer | Polypropylene Melt-Blown Fabric | Melt blown polypropylene filter | |
| Inner facing layer | Polypropylene Non-Woven Fabric | Spun-bond polypropylene | |
| nose clip | Polypropylene and Iron Wire | Malleable aluminum wire | |
| Ear loop | Nylon and Spandex | Polyester | |
| Biocompatibility | |||
| Cytotoxicity | No Cytotoxicity | No Cytotoxicity | Same |
| Sensitization | No Sensitization | No Sensitization | Same |
| Irritation | No Irritation | No Irritation | Same |
Table 1 Comparison of Surgical Face Mask
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Different - Design feature
The design feature for the proposed device is ear loop type, which can be covered with that for the predicate device, namely ear loop type and tie-on type. In addition, both ear loop type and tie-on type are designed to secure the mask to the user's mouth and nose, which will not affect the indication for use and will not cause safety problems. Thus, difference in design feature will not affect the safety and effectiveness of the proposed device.
Similar - Dimension
The dimension of the proposed device is the same as that of the predicate device, and the proposed device details the dimensions of the nose clip and ear loop. Therefore, this difference does not affect the safety and effectiveness of the proposed device.
Different - Sterilization
The final product status of the proposed device is different from predicate device, one is sterilized and the other is non-sterilized. Sterilization will affect the safety and effective of the mask. The performance testing of the proposed device has been conducted on the final product and the test results show that the proposed sterile mask meets the requirements of ASTM F2100-2019. And biocompatibility testing of the proposed device has also been conducted on the final product and the test results showed that there are no negative impacts from the materials that are used in the proposed sterile mask. Therefore, although there differences between the proposed device and predicate device, the differences do not raise the issue of safety and effectiveness of the proposed device.
Different - Particulate filtration efficiency
The test result for particulate efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.
Different - Bacterial filtration efficiency
The test result for bacteria efficiency for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.
8
Different - Differential pressure
The test result for different pressure for the proposed device is different from predicate device. However, the test result for the proposed device can meet the requirements of level 2 mask. Thus, this difference does not affect the safety and effectiveness of the proposed device.
Different - Patient Contacting Material
The patient contacting material for the proposed device is different from predicate device. However, biocompatibility test has been performed on the proposed device and the results does not show any adverse effect. Thus, this difference in materials will not affect the safety and effectiveness of the proposed device.
Conclusion 9.
The conclusion drawn from the non-clinical tests demonstrates that the subject device in 510(k) submission K202904, the Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K173062.