Who is the manufacturer of Face Mask?

Jinhua Jingdi Medical Supplies Co., Ltd. filed the 510(k) submission for Face Mask (K210007).

What is the FDA product code for 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 Face Mask?

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

Who can help prepare an FDA 510(k) submission like 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.

Face Mask

K210007 · Jinhua Jingdi Medical Supplies Co., Ltd. · FXX · Apr 23, 2021 · General, Plastic Surgery

Device Facts

Record ID	K210007
Device Name	Face Mask
Applicant	Jinhua Jingdi Medical Supplies Co., Ltd.
Product Code	FXX · General, Plastic Surgery
Decision Date	Apr 23, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4040
Device Class	Class 2

Intended Use

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

Device Story

Face mask; three-layer flat-pleated design; outer/inner layers spun-bond polypropylene; middle layer melt-blown polypropylene; malleable iron wire nose piece; ear loops (polyamide/spandex). Single-use, disposable, non-sterile. Used in clinical settings for infection control; worn by patients and healthcare personnel. Provides Level 2 barrier protection against blood/body fluids. Protects against transfer of microorganisms and particulates.

Clinical Evidence

No clinical data. Bench testing only. Compliance with ASTM F2100-19, ASTM F1862 (fluid resistance), ASTM F2299 (PFE 99.70%), ASTM F2101 (BFE 99.95%), MIL-M-36954C (Delta P 3.0 mmH2O/cm2), 16 CFR Part 1610 (Class 1 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 polypropylene cover. Ear loops (75% polyamide, 25% spandex). Dimensions: 145x95mm or 175x95mm. Meets ASTM F2100 Level 2 barrier specifications. Non-sterile. Mechanical filtration principle.

Indications for Use

Indicated for use by patients and healthcare personnel to reduce exposure to microorganisms, body fluids, and particulate material in infection control settings.

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 (K182514)

Reference Devices

Disposable Surgical Face Mask (K202491, Model: EL-M02 and EL-L02 Level 2)

Related Devices

K210244 — Disposable Medical Face Mask · Suzhou Bolisi Medical Technology Co., Ltd. · Jul 12, 2021
K202331 — Medical Face Mask · Gemtier Medical (Shanghai), Inc. · Feb 2, 2021
K202491 — Disposable Surgical Face Mask · Jiangsu Newvalue Medical Products Co., Ltd. · Jan 6, 2021
K212471 — Medical Face Mask · Haian Medigauze Co., Ltd. · Nov 4, 2021
K221838 — Surgical Face Mask (HNFM0103) · Shanghai Hua EN Industrial Co, Ltd. · Aug 17, 2022

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. April 23, 2021 Jinhua Jingdi Medical Supplies Co., Ltd % Julie Chen RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shangha, 200040 China Re: K210007 Trade/Device Name: Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 4, 2021 Received: March 8, 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. 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 {1}------------------------------------------------ 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 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, Ryan Ortega, PhD 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 Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ### Indications for Use 510(k) Number (if known) K210007 Device Name Face Mask Indications for Use (Describe) The 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 Face Masks are single use, disposable devices, 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." PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ # 510(K) Summary - K210007 #### I. SUBMITTER: Jinhua Jingdi Medical Supplies Co.,Ltd Building 2, Ditian Function, Xiaoshun Town, JindongZone, Jinhua City, Zhejiang, China Contact Person: Hu Xiaojiang Title: Quality Manager Tel: +86 13989428215 Email: xiaojianghu@jhjingdi.com Submission Correspondent: Julie Chen Email: julie.chen(@mind-link.net Tel:+86 13918045781 Summary prepared: 12/04/2020 #### II. DEVICE Name of Device: 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: Surgical Face Masks (K182514) #### IV. REFERENCE DEVICE Reference device: Disposable Surgical Face Mask (K202491, Model: EL-M02 and EL-L02 Level 2) {4}------------------------------------------------ #### V. DEVICE DESCRIPTION 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, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (Iron wire covered by polypropylene) to provide a firm fit over the nose. There are two models for Face Mask with different colors and sizes. For Type A model is in blue, barrier level 2 and size 145mm*95mm, ear loop type. For Type B model is in blue, barrier level 2 and size 175mm*95mm, ear loop type. #### VI. INDICATIONS FOR USE The 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 Face Masks are single use, disposable device, provided non-sterile. ### COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE The Face Masks are compared with the predicate device (Surgical Face Masks (K182514)). The results are shown below in the Technological Characteristics Comparison Table: | DEVICE | Subject Device Face Mask | Primary Predicate Device Surgical Face Mask (K182514) | Reference Device Disposable Surgical Face Mask (K202491, Level 2) | Remark | |---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------| | Intended Use | The 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 | 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 | The Disposable Surgical Face Mask 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 | Same | | | to reduce the potential exposure to blood and body fluids. The Face Masks are single use, disposable device, provided non-sterile. | infection control practices to reduce the potential exposure to blood and body fluids. This is a single-use, disposable device, provided non- sterile. | to reduce the potential exposure to blood and body fluids. The Disposable Surgical Face Masks are single use, disposable devices, provided non-sterile. | | | Classification | FXX | FXX | FXX | Same | | Product Code | | | | | | Ear Loop Model | Ear Loops | Ear Loops | Ear Loops | Same | | | | Materials | | | | Outer Facing Layer | Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene | Spun-bond Polypropylene non-woven fabric | Similar Note 1 | | Middle Layer | Melt-blown polypropylene | Melt blown polypropylene filter | Melt blown polypropylene | Similar Note 1 | | Inner Facing Layer | Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene | Spun-bond polypropylene non-woven fabric | Similar Note 1 | | Nose Piece | Iron wire covered polypropylene | Malleable aluminum wire | Malleable iron wire with plastic covering | Similar Note 1 | | Ear Loops | 75%Polyamie 25% Spandex | Polyester | Spandex Elastic cord | Similar Note 1 | | | | Design Features | | | | Color | Blue | White | Blue | Different Note 1 | | Style | Flat - Pleated | Flat - Pleated | Flat - Pleated | Same | | Multiple Layers | 3 Layers | 3 Layers | 3 Layers | Same | | Single Use | Single use | Single use | Single use | Same | | | | Sterility | | | | Sterile | Non-sterile | Non-sterile | Non-sterile | Same | | | | Dimensions | | | | Length × Width | 145×95mm(±5mm) 175×95mm (±5mm) | 175×95mm(±10mm) | 145×95mm (±5mm) 175×95mm (±5mm) | Different Note 2 | | Technological Characteristics Product Barrier Specifications Per ASTM F2100 - Meets Level 2 | | | | | | Fluid Resistance ASTM F1862 | 32 out of 32 pass at 120mmHg | 32 out of 32 pass at 120mmHg | Pass at 120mmHg | Same | | Particulate Filtration Efficiency (PFE) | Pass at 99.70% | Pass at 99.88% | Pass at >99.8% | Same | | ASTM F2299 | | | | | | Bacterial Filtration Efficiency (BFE) ASTM F2101 | Pass at 99.95% | Pass at 99.6% | Pass at $\ge$ 99.8% | Same | | Differential Pressure (Delta P)MIL- M-36954C | Pass at $3.0 mmH_2O/cm^2$ | Pass at $3.0 mmH_2O/cm^2$ | Pass at $<4.2mmH_2O/cm^2$ | Same | | Flammability 16 CFR PART 1610 | Class 1 Non-Flammable | Class 1 Non-Flammable | Class 1 Non-Flammable | Same | | Biocompatibility | | | | | | Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Same | | Irritation | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non- irritating. | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non- irritating. | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Same | | Sensitization | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non- sensitizing | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non- sensitizing. | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Same | {5}------------------------------------------------ {6}------------------------------------------------ ## Comparison in Detail(s): Note 1: Although the material including outer facing layer, inner facing layer, nose piece and ear loops, as well as the color of the subject device and the color is different from the predicate device, it meets the requirement of essential performance standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device. # Note2: Although Type A of the subject device is smaller than the predicate device, Type A match the dimension with reference device (Model: EL-M02, Level 2), the barrier protection performance of the subject device is same with the barrier protection performance of predicate device and the reference device, which is the Level 2 barrier protection. Therefore, the dimensional differences between the predicate device and the subject device will not affect the safety and effectiveness of {7}------------------------------------------------ the subject device. ### 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 Face Masks complies with the following standards: - ASTM F2100-19 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) - EN 14683:2019+AC2019(E) Annex C . - 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. #### IX. CONCLUSION The conclusion drawn from the nonclinical tests demonstrates that the Face Mask subject device of this submission, K210007, is as safe, as effective, and performs as well as or better than the legally marketed predicate device Surgical Face Masks (K182514).