Who is the manufacturer of Medical Face mask?

Jiangsu Province Jianerkang Medical Dressing Co., Ltd. filed the 510(k) submission for Medical Face mask (K202061).

What is the FDA product code for Medical Face 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 Face mask?

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

What are the predicate devices for Medical Face mask?

Surgical Face Masks (Ear loops and Tie-on) (K160269).

Who can help prepare an FDA 510(k) submission like Medical Face 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 Face mask

K202061 · Jiangsu Province Jianerkang Medical Dressing Co., Ltd. · FXX · Dec 23, 2020 · General, Plastic Surgery

Device Facts

Record ID	K202061
Device Name	Medical Face mask
Applicant	Jiangsu Province Jianerkang Medical Dressing Co., Ltd.
Product Code	FXX · General, Plastic Surgery
Decision Date	Dec 23, 2020
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile.

Device Story

Medical face mask; three-layer flat-pleated design; inner/outer layers polypropylene; middle layer melt-blown polypropylene; spandex/nylon ear loops; steel wire nosepiece. Functions as self-inhalation filter mask; filters microorganisms, body fluids, and particulates from inhaled/exhaled air. Used in clinical or general settings for infection control. Protects patient and healthcare personnel by reducing exposure to blood/body fluids. Non-sterile, single-use.

Clinical Evidence

No clinical data. Bench testing only. Performance testing included Bacterial Filtration Efficiency (99.8%), Sub-micron Particle Filtration Efficiency (96.09%), Differential Pressure (3.9 mm H2O/cm2), Flammability (Class 1), and Synthetic Blood Penetration Resistance (160 mmHg). Biocompatibility testing (cytotoxicity, sensitization, irritation) performed per ISO 10993 standards.

Technological Characteristics

Three-layer construction: polypropylene inner/outer layers, melt-blown polypropylene middle layer. Spandex/nylon ear loops. Steel wire nosepiece. Flat-pleated form factor. Non-sterile. ASTM F2100-19 Level 1 compliant. Mechanical filtration principle.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate materials in infection control practices; reduces potential exposure to blood and body fluids. For single-use, non-sterile, over-the-counter use.

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 Masks (Ear loops and Tie-on) (K160269)

Related Devices

K212471 — Medical Face Mask · Haian Medigauze Co., Ltd. · Nov 4, 2021
K201629 — Medical Face Mask · Shandong Shengquan New Material Co., Ltd. · Dec 14, 2020
K210018 — Disposable Medical Mask · Diasia Biomedical Technology Co., Ltd. · Apr 11, 2021
K202548 — Surgical Face Mask · Wanxinda (Guangzhou) Technology Product Co., Ltd. · Mar 10, 2021
K202491 — Disposable Surgical Face Mask · Jiangsu Newvalue Medical Products Co., Ltd. · Jan 6, 2021

Submission Summary (Full Text)

{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 and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. December 23, 2020 Jiangsu Province Jianerkang Medical Dressing Co., Ltd Hongfang Tang Quality System Director No.1 Jianerkang Road, Zhixi Industry Concentration Area, Zhixi Town, Jintan Changzhou, Jiangsu 213251 China Re: K202061 Trade/Device Name: Medical Face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 4, 2020 Received: November 12, 2020 ## Dear Hongfang Tang: 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 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. 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}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K202061 Device Name Medical face mask Indications for Use (Describe) The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and 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 In accordance with 21 CFR 807.92 the following summary of information is provided: 1. SUBMITTER Jiangsu Province Jianerkang Medical Dressing Co., Ltd. Jianerkang Road, Zhixi Industry Concentration Area, ZhixiTown,213251 Jintan No.1 Changzhou City, PEOPLE'S REPUBLIC OF CHINA. Phone: +86-13585416869 Fax: +86-519-8244 4628 | Primary Contact | Hongfang Tang | |-----------------|-------------------------------------------------------| | Person: | Quality System Director | | | Jiangsu Province Jianerkang Medical Dressing Co., Ltd | | | Tel: (+86)-519-8244 4628 | | | Fax: (+86) -519-8244 4745 | Date prepared December 22th, 2020 - 2. DEVICE | Device Name: | Medical Face mask | |-------------------|-------------------| | Common name: | Mask, Surgical | | Regulation number | 21 CFR 878.4040 | | Regulation Class: | 2 | | Product Code: | FXX | #### PREDICATE DEVICE 3. K160269, Surgical Face Masks (Ear loops and Tie-on) This predicate has not been subject to a design-related recall. - 4. DEVICE DESCRIPTION The medical face mask is designed and manufactured by Jiangsu Province Jianerkang Medical Dressing Co., Ltd. It is non-sterile and for single use. The medical face mask is manufactured with three-layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene. The elastic ear loop of proposed device is made of spandex and nylon, not made with natural rubber latex. The nose piece contained in the proposed device allows the user to fitthe {4}------------------------------------------------ face mask around their nose, which is made from steel wire. It is a self-inhalation filter mask, which works by filtering the air containing microorganisms, body fluids, and particulate matters through the filter material of the mask before being inhaled or exhaled. The product is level 1 according to ASTM F2100-19. The main parameters of the product are listed as followed: - י Bacterial filtration efficiency (BFE) ≥95% - . Sub-micron particle filtration efficiency ≥95% - . Different pressure: <5.0 mm H₂O/cm² - . Flammability: class 1 - . Resistance to penetration by synthetic blood: 80 mmHg #### 5. INDICATIONS FOR USE The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single-use and provided non-sterile. #### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE 6. | | Proposed device | Predicate device | Comparison result | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------| | Manufacturer | Jiangsu Province Jianerkang Medical Dressing Co., Ltd | SAN-M PACKAGE CO., LTD. | NA | | 510K Number | K202061 | K160269 | NA | | Product Common Name | Medical face mask | Surgical Face Masks (Ear loops and Tie-on) | NA | | | | | K202061 | | Intended Use | The medical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate materials in infection control practices to reduce the potential exposure to blood and body fluids. It is for single- use and 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, provided non-sterile. | Same | | Mask style | Flat pleated | Flat pleated | Same | | Design feature | Ear loop | Earloop or tie-on | Similar | | Material of outer facing layer | Polypropylene | Polypropylene | Same | | Material of middle layer | Melt blown polypropylene | Polypropylene meltblown and polypropylene spunbond | Similar | | Material of inner facing layer | Polypropylene | Polypropylene | Same | | Nosepiece | Polypropylene coated steel wire | Polypropylene coated steel wire | Same | | Attachment | Ear loops: Spandex and nylon | Ear loops: Polyester, polyurethane Side tapes: Polyester spunbond (ear loopsmask only) Tie tapes: Polypropylene spunbond or polyester spunbond | Similar | | Color | Blue | Blue, White | Similar | | Dimension (Length × Width) | 17.5 cm × 9.5 cm | 17.5 cm × 9.0 cm 18.0 cm × 9.0 cm | Similar | | OTC use | Yes | Yes | Same | | Sterility | Non-sterile | Non-sterile | Same | | Single use | Yes | Yes | Same | | ASTM F 2100 level | Level 1 | Level 1 Level 2 Level 3 | Similar | | Biocompatibility | | | | | | | | | | Cytotoxicity | Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic. | Under the conditions of the study, the proposed device extract was determined to be non- cytotoxic. | Same | | Irritation | Under the conditions of the study, the proposed device extract was determined to be non-irritating. | Under the conditions of the study, the proposed device extract was determined to be non- irritating. | Same | | Sensitization | Under the conditions of the study, the proposed device extract was determined to be non-sensitizing. | Under the conditions of the study, the proposed device extract was determined to be non- sensitizing. | Same | {5}------------------------------------------------ {6}------------------------------------------------ The subject device is the same as the predicate device in the intended use, material, ASTM F2100 level and biocompatibility, and similar in mask style, design feature and dimension. So the subject device is similar to the predicate device. #### 7. PERFORMANCE DATA The following performance data were provided in support of the substantial equivalence determination. ## Biocompatibility testing The biocompatibility evaluation for the medical face mask was conducted in accordance with the International Standard ISO 10993-1:2018, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" as recognized by FDA. The biocompatible testing included the following tests: - Cytotoxicity - (ISO 10993-5: 2009) - Sensitization - (ISO 10993-10:2010) - Skin Irritation - (ISO 10993-10:2010) ## Performance testing Performance testing was conducted on the medical face mask. All of the tested {7}------------------------------------------------ parameters met the predefined acceptance criteria. | Item | Test Methods | Result value | Level | |-----------------------------------------------------------|-----------------------------------------------|----------------|---------| | Flammability | ASTM F2100-19 16 CFR Part 1610-2008 | NA | Class 1 | | Bacterial Filtration Efficiency | ASTM F2100-2019 9.1 ASTM F2101-2019 | Average 99.8% | Level 3 | | Different Pressure, mm H2O/cm² | ASTM F2100-19 9.2 | Average 3.9 | Level 3 | | Sub-Micron Particle Filtration Efficiency | ASTM F2100-2019 9.3 ASTM F2299/F2299M-2017 | Average 96.09% | Level 1 | | Resistance to Penetration by Synthetic Blood (mmHg) | ASTM F2100-2019 9.4 ASTM F1862/F1862-2017 | 160 | Level 3 | #### 8. CLINICAL DATA No clinical data was included in this submission. #### 9. CONCLUSION The indications for use statement for the subject device is similar to that of the predicate. The differences between the medical face mask and its predicate device do not raise new issues of safety and effectiveness. The non-clinical data support the safety of the device and the performance testing report demonstrate that the medical face mask should perform as intended in the specified use conditions. From the results of non-clinical data including the performance testing described, Jiangsu Province Jianerkang Medical Dressing Co., Ltd concludes that the medical face mask is as safe, as effective, and performs as well as or better than the legally marketed as the predicate device (K160269).