(266 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML technology.
No
A surgical mask is intended to protect against transfer of microorganisms and body fluids, not to directly treat or cure a disease or condition.
No
This device is described as a "Medical Surgical Mask" intended to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. Its function is protective, not diagnostic.
No
The device description clearly outlines physical components like non-woven fabrics, polypropylene melt blown cloth, galvanized iron wire, and spandex, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical components and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies and key metrics focus on the physical properties and filtration capabilities of the mask (flammability, pressure drop, fluid resistance, filtration efficiency). These are relevant to the mask's function as a barrier, not to diagnostic accuracy.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
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 mask does not fit that definition.
N/A
Intended Use / Indications for Use
Medical Surgical 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
FXX
Device Description
Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.
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
healthcare personnel
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
The following bench testing was conducted to demonstrate that the subject device met the acceptance criteria for the relevant standard for this device.
- Flammability (16 CFR 1610): Class 1, Pass
- Delta Pressure (EN 14683:2019): 3.4 mmH2O/cm^2, Pass (= 98 %)
- Particulate filtration efficacy (ASTM F2299): 98.69 %, Pass (>= 98 %)
- Biocompatibility:
- Primary Skin Irritation in rabbits (ISO 10993-10: 2010): Passes. Under the conditions of the study, the subject device is not a primary skin irritant.
- Dermal sensitization in the guinea pig (ISO 10993-10: 2010): Passes. Under the conditions of the study, the subject device is not a primary skin sensitizer.
- In vitro cytotoxicity accordance with ISO 10993-5: 2019: Passes. Under the conditions of the study, the subject device is not cytotoxic.
Key Metrics
- Particulate Filtration Efficiency (ASTM F2299): 98.69 %
- Fluid resistance (ASTM F1862): 32 out 32 pass at 120 mmHg (level 2)
- Bacterial Filtration efficiency (ASTM F2101): 99.80 %
- Flammability (16 CFR 1610): Class 1
- Delta-Pressure (EN14683:2019): 3.4 mmH2O/cm^2
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol is a stylized representation of a human figure, while the FDA name is written in blue and includes the words "U.S. Food & Drug Administration".
March 15, 2021
Hangzhou Mycode Bio-Medicine Co., Ltd. Alice Gong Manager Floor 4, Building No. 4, No. 2 Xiyuansi Road, Xihu District Hangzhou, Zhejiang 310030 China
Re: K201698
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 5, 2021 Received: February 10, 2021
Dear Alice Gong:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (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 mediation-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 Ryan Ortega Ph. D 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)
Device Name Medical Surgical Mask
Indications for Use (Describe)
Medical Surgical 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
510(k) Summary K201698
| 1.0 Submitter: | |
|---|---|
| Submitter's name: | Hangzhou Mycode Bio-Medicine Co., Ltd. |
| Submitter's address: | Floor 4, Building No. 4, No. 2 Xiyuansi Road, Xihu District, |
| Hangzhou, China | |
| Phone number: | 86-571-87329869 |
| Name of contact person: | Ms. Alice Gong |
| Summary Preparation | |
| Date: | Feb. 5, 2021 |
| Summary Revision: | Rev. 2 |
| 2.0 Name of the Device | |
| Proprietary/Trade name: | Medical Surgical Mask |
| Common Name: | Surgical Mask |
| 510(k) Number: | K201698 |
| Classification Name: | Mask, Surgical |
| Device Classification: | Class II |
| Regulation Number: | 21 CFR 878.4040 |
| Product Code: | FXX |
| 3.0 Predicate device | |
| Device Name: | SURGICAL FACE MASK |
| Company name: | Wuhan Dymex Healthcare Co., Ltd |
| 510(K) Number: | K182515 |
4.0 Device Description
Medical Surgical Masks are disposable medical masks and are made of mask body, nose clips and mask belt by ultrasonic heat sealing. The mask body is divided into three layers: inner, middle and outer layers, the inner and outer layers are Non-woven fabrics and middle layer is polypropylene melt blown cloth, nose piece is made of galvanized iron wire covered plastic materials. The mask belt is made of spandex. The mask style is flat pleated.
5.0 Indications for Use
Medical Surgical 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.
6.0 Summary of the Technological Characteristics of the Device:
Provided below is a comparison of the subject device to the predicate device.
| Device
Characteristic | Subject Device | Predicate Device | Comparison
(Same,
similar,
different) |
|--------------------------|----------------------------------------|---------------------------------|------------------------------------------------|
| Product name | Medical Surgical Mask | SURGICAL FACE MASK | N/A |
| 510(K) No. | K201698 | K182515 | N/A |
| Product Owner | Hangzhou Mycode Bio-Medicine Co., Ltd. | Wuhan Dymex Healthcare Co., Ltd | N/A |
| Product Code | FXX | FXX | Same |
4
| Regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
|---|---|---|---|
| Class | Class II | Class II | Same |
| Indications for Use | Medical Surgical 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 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. | Same | ||
| Color | White | Yellow | Different |
| Single Use | Single Use, Disposable | Single Use, Disposable | Same |
| Sterile | Non-Sterile | Non-Sterile | Same |
| Dimensions- | |||
| Length | 17.5cm±5% | 17.5cm±0.2cm | Similar |
| Dimensions- | |||
| Width | 9.5cm±5% | 9.5cm±0.2cm | Similar |
| Ear loops | Yes, Spandex | Yes, Spandex | Similar |
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| (ASTM F2299) | 98.69 % | 99.7% | Similar |
| Fluid resistance | |||
| (ASTM F1862) | 32 out 32 pass | ||
| at 120 mmHg (level 2) | 32 out of 32 pass at 120 | ||
| mmHg | Same | ||
| Bacterial Filtration | |||
| efficiency | |||
| (ASTM F2101) | 99.80 % | 99.9% | Similar |
| Flammability | |||
| (16 CFR 1610) | Class 1 | Class 1 | Same |
| Delta-Pressure | |||
| (EN14683:2019) | 3.4 mmH2O/cm² | 4.0mmH2O/cm² | Similar |
| Biocompatibility | |||
| Cytotoxicity (ISO | |||
| 10993-5: |
Skin Irritation
(ISO 10993-10:
2010)
Skin sensitization | All items passed | All items passed | Same |
5
7.0 Summary of f Non-Clinical Performance Data:
The following bench testing was conducted to demonstrate that the subject device met the acceptance criteria for the relevant standard for this device.
| Summary of Non-clinical Testing | |||
|---|---|---|---|
| Name of the standard | |||
| Characteristic tested | Subject device tested per | ||
| ASTM F-2100 | Passing Standard | ||
| acceptance criteria | Result | ||
| Flammability | |||
| (16 CFR 1610) | Class 1 | Class 1 | Pass |
| Delta Pressure | |||
| (EN 14683:2019) | $3.4 \text{ mmH}_2\text{O/cm}^2$ | $ |