Who is the manufacturer of Medical Surgical Mask?

Hangzhou Mycode Bio-Medicine Co., Ltd. filed the 510(k) submission for Medical Surgical Mask (K201698).

What is the FDA product code for Medical Surgical Mask?

FXX. It is classified under 21 CFR 878.4040 as a Class 2 device in the General, Plastic Surgery panel.

What is the regulatory pathway for Medical Surgical Mask?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Medical Surgical Mask?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Medical Surgical Mask

K201698 · Hangzhou Mycode Bio-Medicine Co., Ltd. · FXX · Mar 15, 2021 · General, Plastic Surgery

Device Facts

Record ID	K201698
Device Name	Medical Surgical Mask
Applicant	Hangzhou Mycode Bio-Medicine Co., Ltd.
Product Code	FXX · General, Plastic Surgery
Decision Date	Mar 15, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended 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.

Device Story

Disposable, flat-pleated medical surgical mask; three-layer construction (non-woven outer/inner layers, polypropylene melt-blown middle layer); includes galvanized iron wire nose clip and spandex ear loops; assembled via ultrasonic heat sealing. Used in clinical settings for infection control; worn by patients and healthcare personnel to provide barrier protection against microorganisms, body fluids, and particulates. Device is non-sterile and single-use.

Clinical Evidence

No clinical data. Bench testing only: Flammability (16 CFR 1610), Delta Pressure (EN 14683), Fluid Resistance (ASTM F1862), Bacterial Filtration Efficiency (ASTM F2101), Particulate Filtration Efficiency (ASTM F2299), and Biocompatibility (ISO 10993-5, ISO 10993-10).

Technological Characteristics

Three-layer non-woven/polypropylene melt-blown construction; galvanized iron wire nose clip; spandex ear loops; ultrasonic heat sealing. Standards: ASTM F2100, ASTM F1862 (120 mmHg), ASTM F2101, ASTM F2299, 16 CFR 1610 (Class 1), ISO 10993-5, ISO 10993-10. Non-sterile, single-use, flat-pleated form factor.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material; intended for infection control to reduce exposure to blood and body fluids.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

SURGICAL FACE MASK (K182515)

Related Devices

K202491 — Disposable Surgical Face Mask · Jiangsu Newvalue Medical Products Co., Ltd. · Jan 6, 2021
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K253398 — Disposable Surgical Mask (Non-Sterile) (EFX3PLBLKMSK300) · Efofex, Inc. · Feb 19, 2026
K210348 — Disposable Medical Surgical Mask · Weihai Dishang Medical Technology Co., Ltd. · Oct 24, 2021
K202137 — Disposable medical mask · U-Play Products Corporation · Mar 4, 2021

Submission Summary (Full Text)

{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) K201698 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) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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: 2019) 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) | $3.4 \text{ mmH}_2\text{O/cm}^2$ | $< 5.0 \text{ mmH}_2\text{O/cm}^2$ | Pass | | Fluid Resistance (Provide the number of masks that pass the test) (ASTM F1862) | 32 out 32 pass at 120 mmHg level 2 | 120 mmHg (level 2) | Pass | | Bacterial filtration efficacy (ASTM F2101) | 99.80 % | ≥ 98 % | Pass | | Particulate filtration efficacy (ASTM F2299) | 98.69 % | ≥ 98 % | Pass | | 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. | Passes | | | 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. | Passes | | | In vitro cytotoxicity accordance with ISO 10993-5: 2019 | Passes Under the conditions of the study, the subject device is not cytotoxic | Passes | ## 8.0 Clinical Performance Data: Clinical data was not needed for the subject device. ## 9.0 Conclusion: The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K201698, the Medical Surgical Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515