Who is the manufacturer of Medical Face Mask?

Gemtier Medical (Shanghai), Inc. submitted the Traditional clearance for Medical Face Mask (K202331).

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).

Medical Face Mask

K202331 · Gemtier Medical (Shanghai), Inc. · FXX · Feb 2, 2021 · General, Plastic Surgery

Device Facts

Record ID	K202331
Device Name	Medical Face Mask
Applicant	Gemtier Medical (Shanghai), Inc.
Product Code	FXX · General, Plastic Surgery
Decision Date	Feb 2, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

The Medical 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. The Medical Face Masks are single use, disposable device, provided non-sterile.

Device Story

Three-layer, flat-pleated medical face mask; outer/inner layers spun-bond polypropylene; middle layer melt-blown polypropylene; includes malleable iron wire nose piece with plastic covering; secured via spandex elastic ear loops or spun-bond polypropylene tie strings. Single-use, disposable, non-sterile. Used in clinical settings for infection control; worn by healthcare personnel and patients to reduce exposure to blood, body fluids, and particulates. Provides physical barrier; performance meets ASTM F2100 Level 2 requirements.

Clinical Evidence

No clinical data. Bench testing only. Performance verified against ASTM F2100, F1862 (fluid resistance), F2299 (PFE), F2101 (BFE), MIL-M-36954C (Delta P), 16 CFR 1610 (flammability), and ISO 10993 (biocompatibility/cytotoxicity/irritation/sensitization).

Technological Characteristics

Three-layer construction: spun-bond polypropylene (outer/inner), melt-blown polypropylene (middle). Malleable iron wire nose piece with plastic covering. Spandex elastic ear loops or polypropylene tie strings. Flat-pleated form factor. Non-sterile. Meets ASTM F2100 Level 2 specifications.

Indications for Use

Indicated for use by patients and healthcare personnel to protect against transfer of microorganisms, body fluids, and particulate material in infection control practices.

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

Disposable Surgical Face Mask (K153496)

Related Devices

K210244 — Disposable Medical Face Mask · Suzhou Bolisi Medical Technology Co., Ltd. · Jul 12, 2021
K210007 — Face Mask · Jinhua Jingdi Medical Supplies Co., Ltd. · Apr 23, 2021
K252650 — Disposable Medical Face Mask · Makrite Industries, Inc. · Jan 5, 2026
K202493 — Medical Face Mask · Gemtier Medical (Shanghai), Inc. · Feb 4, 2021
K202676 — Disposable Medical Face Mask · Zhejiang Senhong Medical&Instrument Co., Ltd. · Nov 5, 2021

Submission Summary (Full Text)

{0}------------------------------------------------ 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. February 2, 2021 Gemtier Medical (Shanghai) Inc % Julie Chen Technical Manager Shanghai Medical Business Consulting Co.,Ltd. No. 170 Huajiang Road, Jiading District Shanghai, 201803 China Re: K202331 Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 24, 2020 Received: January 6, 2021 Dear Julie Chen: 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 (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) K202331 Device Name Medical Face Mask Indications for Use (Describe) The Medical 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. The Medical Face Masks are single use, disposable device, 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." Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 {3}------------------------------------------------ # 510(K) Summary-K202331 #### I. SUBMITTER: Gemtier Medical (Shanghai) Inc. No.18 Jianding road, Fengjing town, Jinshan district, Shanghai, China, 201502 Contact Person: Li Zhi Qing Title: RA Director Phone: (+86) 189 1703 5908 Email: lizhiqing@jintayiqi.com Submission Correspondent: Julie Chen Title: RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District, Shanghai, China, 200040 Email: julie.chen@medicalbc.net Tel: +86 139 1804 5781 Summary prepared: 01/18/2021 #### II. DEVICE Name of Device: Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX III. PREDICATE DEVICE Primary predicate device: Disposable Surgical Face Mask (K153496) {4}------------------------------------------------ #### IV. DEVICE DESCRIPTION The Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer (meltblown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains tie strings (spun-bond polypropylene) or ear loops (spandex elastic cord) to secure the mask over the users' mouth and face and includes a malleable nose piece (iron wire with white plastic covering) to provide a firm fit over the nose. | REF No. | Product Size | Model Description | | | |---------|--------------|-------------------|---|---| | Mask | Ear Loop | Tie-on | | | | NS2R-D1 | 17.5×9.5cm | X | X | | | NS2R-01 | 17cm×9.5cm | X | X | | | NS2R-C1 | 14.5cm×9.5cm | X | X | | | NS2R-I1 | 17.5×9.5cm | X | X | X | | NS2R-E1 | 17cm×9.5cm | X | X | X | | NS2R-H1 | 14.5cm×9cm | X | X | X | #### V. Available Models #### VI. INDICATIONS FOR USE The Medical 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. The Medical Face Masks are single use, disposable device, provided non-sterile {5}------------------------------------------------ ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE VII. PREDICATE DEVICE The Medical Face Masks are compared with the predicate device (Disposable Surgical Face Mask (K153496)). The results are shown below in the Technological Characteristics Comparison Table: | | Subject Device Medical | Primary Predicate Device | Remark | |---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------| | DEVICE | Face Mask (K202331) | Disposable Surgical Face Mask (K153496) | | | Intended Use | The Medical 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. The Medical Face Masks are single use, disposable device, provided non-sterile. | The Disposable 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 | | Classification Product Code | FXX | FXX | Same | | Ear Loop Model and Tie-on Model | Ear Loops, Tie-On | Ear Loops, Tie-On | Same | | Materials | | | | | Outer Facing Layer | Spun-bond Polypropylene | Spun-bond polypropylene | Similar | | Middle Layer | Melt-blown polypropylene | Melt blown polypropylene filter | Similar | | Inner Facing Layer | Spun-bond Polypropylene | Spun-bond polypropylene | Similar | | Nose Piece | Malleable iron wire with plastic covering | Malleable aluminum wire | Different 1 | | Tie Strings | Spun-bond Polypropylene | Spun-bond polypropylene | Similar | {6}------------------------------------------------ | Ear Loops | Spandex elastic cord | Polyester | Similar | |----------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------|---------| | Design Features | | | | | Color | Blue | Blue | Same | | Style | Flat - Pleated | Flat - Pleated | Same | | Multiple Layers | 3 Layers | 3 Layers | Same | | Single Use | Single use | Single use | Same | | Sterility | | | | | Sterile | Non-sterile | Non-sterile | Same | | Dimensions | | | | | Length × Width | 175×95mm (±5%) 170×95mm (±5%) 145×95mm (±5%) | 17.5×9.5cm (±1cm) | Similar | | | Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2 | | | | Fluid Resistance ASTM F1862 | 32/32 passed at 120 mmHg | 32/32 passed at 120 mmHg | Similar | | Particulate Filtration Efficiency (PFE) ASTM F2299 | 99.35% | 98.46% | Similar | | Bacterial Filtration Efficiency (BFE) ASTM F2101 | 99.9% | 98.7% | Similar | | Differential Pressure (Delta P) MIL-M-36954C | 2.11mmH2O/cm² | 4.2mmH2O/cm² | Similar | | Flammability 16 CFR PART 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Similar | | Biocompatibility | | | | | Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Same | | Irritation (ISO 10993-10) | Non-sensitizing | Non-sensitizing | Same | | Sensitization (ISO 10993-10) | Non-irritating | Non-irritating | Same | # Analysis 1 The material of nose piece of the subject device is different from the material of nose piece of the predicate device. To illustrate the difference does not raise any safety and effectiveness questions, we conducted non-clinical tests. The data drawn from the tests shows that the subject device is as safe as effective as predicate device. {7}------------------------------------------------ #### VIII. PERFORMANCE DATA ### Non-Clinical Performance Test Conclusion Non-clinical tests were conducted to verify that the proposed device met all design specifications was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the Medical Face Mask complies with the following standards: - . ASTM F2100 Standard Specification for Performance of Materials Used in Medical Face Masks - ASTM F1862 Standard Test Method for Resistance of Medical Face Masks to . Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) - ASTM F2299 Standard Test Method for Determining the Initial Efficiency of . Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres - ASTM F2101 Standard Method for Evaluating the Bacterial Filtration ● Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus - MIL-M- 36954C Military Specification, Mask, Surgical, Disposable ● - 16 CFR Part 1610 Standard for the Flammability of Clothing ● - ISO10993-1 Biological evaluation of medical devices Part 1: Evaluation and ● testing within a risk management process - . ISO10993-5 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity of medical devices - ISO10993-10 Biological Evaluation of Medical Devices Part 10: Tests for . Irritation and Skin Sensitization Clinical Test Conclusion No clinical study is included in this submission. {8}------------------------------------------------ # Table 1 Summary of Performance Test | Performance Characteristics | Methodology | Purpose | Acceptance Criteria | Test Result | |--------------------------------------------------------------------------------------------------|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------| | Bacterial Filtration Efficiency Performance(%) | ASTM F2101 | This performance test aims to verify Bacterial Filtration Efficiency (BFE) of the Medical face mask reaches level 2 as required in ASTM F 2100- 2019 | ≥98 | 99.9% | | Differential Pressure (Delta- P) (mm H2O/cm²) | MIL-M-36954C | This performance test aims to verify the breathing resistance of Medical face mask reaches level 2 as required in ASTM F 2100-2019 | <6.0 | 2.11mmH2O/cm² | | Particulate Filtration Efficiency at 0.1micron Performance (%) | ASTM F2299 | This performance test aims to verify the Particulate Filtration Efficiency of Medical face mask reaches level 2 as required in ASTM F 2100-2019 | ≥98 | 99.35% | | Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass results | ASTM F1862 | To verify the fluid resistance of the Medical face mask reaches level 2 as required in ASTM F 2100-2019, through perform the fluid resistance testing. | 120 | 32/32 passed at 120 mmHg | | Flammability Class | 16 CFR PART 1610 | To verify the flammability of the Medical face mask reaches level 2 as required in ASTM F 2100-2019, through conduct the flammability testing | Class 1 | Class 1 | | Cytotoxicity | ISO 10993-5:2009 | The purpose of the test is to determine the biological reactivity of mammalian cell culture (mouse fibroblast L929 | If viability is reduced to < 70% of the blank, it has a cytotoxic potential. | Non-cytotoxic | | | | cells) in response to the test article | | | | Irritation | ISO 10993-10: 2010 | The teat was designed to evaluate the potential of a test article cause skin irritation | Use only 24±2h, 48±2h and 72±2h observation for calculation. The primary irritation index for the test article was evaluated according to as follow: (0- 0.4)negligible;(0.5- 1.9)slight;(2- 4.9)moderate;(5- 8)severe | Non-sensitizing | | Sensitization | ISO 10993-10: 2010 | The teat was designed to evaluate the potential of a test article cause skin sensitization | Magnusson and Kingman grades of 1 or greater in the test group generally indicate sensitization. | Non-irritating | {9}------------------------------------------------ #### IX. CONCLUSION The conclusions drawn from the nonclinical tests demonstrate that the subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device Disposable Surgical Face Mask (K153496).