(221 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No
The device is a face mask used for protection against microorganisms and fluids, not for treating a disease or condition.
No
Explanation: The device is a face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. Its purpose is protective, not diagnostic.
No
The device description clearly outlines physical components (three-layer mask, straps, nose piece) and the performance studies focus on material properties and physical performance, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices that are used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside of the body.
- Device Function: The description clearly states that this device is a "Disposable Medical Face Mask" intended to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Intended Use: The intended use is for "infection control practices to reduce the potential exposure to blood and body fluids." This is a protective function, not a diagnostic one.
- No Biological Samples: The device does not interact with or analyze any biological samples from the patient.
- Performance Studies: The performance studies listed (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, etc.) evaluate the physical and barrier properties of the mask, not its ability to diagnose a condition based on biological samples.
Therefore, based on the provided information, this device is a medical device but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable 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 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.
Product codes
FXX
Device Description
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene with steel wire.
The proposed devices are sold non-sterile and are intended to be single use. disposable devices.
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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Performance testing results:
- Fluid Resistance Performance (ASTM F1862): 32 out of 32 pass at 120 mmHg
- Particulate Filtration Efficiency (ASTM F2299): 99.8%
- Bacterial Filtration Efficiency (ASTM F2101): 99.9%
- Differential Pressure (EN 14683:2019): 3.7 mmH2O/cm2
- Flammability (16 CFR 1610): Class 1
Biocompatibility testing results:
- Cytotoxicity (ISO 10993-5:2009): No potential toxicity
- Irritation (ISO 10993-10:2010): No potential skin irritation
- Sensitization (ISO 10993-10:2010): No potential skin sensitization
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid Resistance Performance (ASTM F1862): 32 out of 32 pass at 120 mmHg
- Particulate Filtration Efficiency (ASTM F2299): 99.8%
- Bacterial Filtration Efficiency (ASTM F2101): 99.9%
- Differential Pressure (EN 14683:2019): 3.7 mmH2O/cm2
- Flammability (16 CFR 1610): Class 1
- Cytotoxicity (ISO 10993-5:2009): No potential toxicity
- Irritation (ISO 10993-10:2010): No potential skin irritation
- Sensitization (ISO 10993-10:2010): No potential skin sensitization
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.
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April 9, 2021
Shenzhen Jinko Industrial Co., Ltd % Joyce Yang Consultant Shenzhen Joyantech Consulting Co., Ltd 1713A, 17th Floor, Block A, Zhongguan Times Square Nanshan District Shenzhen, Guangdong 518100 China
Re: K202513
Trade/Device Name: Disposable Medical Face Mask (Model FM-04) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 3, 2021 Received: March 12, 2021
Dear Joyce Yang:
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.
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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 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.
Bifeng Qian -S
For Clarence W. Murray, III, 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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K202513
Device Name Disposable Medical Face Mask (Model FM-04)
Indications for Use (Describe)
The Disposable 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 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 nonsterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510(k) Number: K202513 Date of Summary prepared: April 8, 2021
This summary of 510(K) safety and effectiveness information is submitted as required by requirements of SMDA and 21 CFR §807.92.
1. Submission Sponsor
| Applicant Name | Shenzhen Jinko industrial Co., Ltd. |
|---|---|
| Address | Building B2 101, Haocheng(Heping) Industrial |
| Park, No. 66 Hexiu West Road, Heping | |
| Community, Fuhai Street, Baoan District, | |
| Shenzhen, Guangdong, China. | |
| Contact person | Wang Yinghui |
| Phone | +0086-400-990-9777 |
| Submission correspondent | |
| Name | Shenzhen Joyantech Consulting Co., Ltd |
| Address | 1713A, 17th Floor, Block A, Zhongguan Times |
| Square, Nanshan District, Shenzhen | |
| Post Code | 518000 |
| Phone No. | +86-755-86069197 |
| Contact Person | Joyce Yang |
| joyce@cefda.com |
3. Device Identification
| Type of 510(k) submission: | Traditional |
|---|---|
| Trade Name: | Disposable Medical Face Mask |
| Model: | FM-04 |
| Classification name: | Mask, Surgical |
| Review Panel: | Surgical Apparel |
| Product Code: | FXX |
| Device Class: | II |
| Regulation Number: | 878.4040 |
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4. Legally Marketed Predicate Device
| Trade Name | Disposable Surgical Face Mask |
|---|---|
| Regulation number | 878.4040 |
| Regulation class | II |
| Regulation name | Surgical Apparel |
| 510(k) Number | K153496 |
| Product Code | FXX |
| Manufacturer | Xiantao Rayxin Medical Products Co.,Ltd. |
Device Description 5.
The proposed devices are single use, three-layer, flat masks with straps and nose piece. The Disposable Medical Face Masks are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter.
The proposed device is held in place over the user's mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the proposed device is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polyethylene with steel wire.
The proposed devices are sold non-sterile and are intended to be single use. disposable devices.
6. Intended Use/ Indications for Use
The Disposable 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 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.
7. Technological characteristics of the subject device compared to the predicate device
7.1 Predicate Device Information:
| 510(K) No.: | K153496 |
|---|---|
| Common name: | Disposable Surgical Face Mask |
| Classification name: | Mask, Surgical |
| Production regulation: | 21 CFR § 878.4040 |
| Product code: | FXX |
| Panel: | Surgical Apparel |
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7.2 Comparison to predicate device:
The Disposable Medical Face Mask is compared with the predicate device Disposable Surgical Face Mask(K153496). The product characteristics are shown as follow:
| Comparison
| item | Subject Device (K202513) | Predicate Device (K153496) | Comments |
|---|---|---|---|
| Applicant | Shenzhen Jinko industrial Co., | ||
| Ltd. | Xiantao Rayxin Medical | ||
| Products Co.,Ltd. | / | ||
| Product | |||
| name | Disposable Medical Face Mask | Disposable Surgical Face | |
| Mask | / | ||
| Product | |||
| Code | FXX | FXX | Same |
| Regulation | |||
| Number | 21 CFR § 878.4040 | 21 CFR § 878.4040 | Same |
| Classificatio | |||
| n | Class II | Class II | Same |
| OTC use | Yes | Yes | Same |
| Intended | |||
| use & | |||
| Indications for Use | The Disposable 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 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. | The Disposable 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 mask 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 | ||
| Design | |||
| feature | Ear-loop | Ear-loop, Tie-on | Similar |
| Issue 1 | |||
| Usage | Single use | Single use | Same |
| Color | Blue | Blue | Same |
| Size | $(175±8)mm×(95+4.5)cm$ | $(17.5±1)cm×(9.5±1)cm$ | Similar |
| Issue 2 | |||
| Comparison | |||
| item | Subject Device (K202513) | Predicate Device (K153496) | Comments |
| Sterile | Non-sterile | Non-sterile | Same |
| Material | Outer layer: Spun-bond | ||
| polypropylene | Outer layer: Spun-bond | ||
| polypropylene | Same | ||
| Middle layer: Melt blown | |||
| polypropylene filter | Middle layer: Melt blown | ||
| polypropylene filter | Same | ||
| Inner layer: Spun-bond | |||
| polypropylene | Inner layer:Spun-bond | ||
| polypropylene | Same | ||
| Nose piece:PE+Steel wire | Nose piece:Malleable | ||
| aluminum wire | Difference | ||
| Issue 3 | |||
| Ear loops: Spandex | Ear loops:Polyester | Similar | |
| Issue 4 | |||
| ASTM F | |||
| 2100 Level | Level 2 | Level 2 | Same |
| Fluid | |||
| Resistance | |||
| Performance | |||
| ASTM F | |||
| 1862-13 | 32 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 | |
| mmHg | Same | ||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM F | |||
| 2299 | 99.8% | 98.46% | Similar |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM F | |||
| 2101 | 99.9% | 98.7% | Similar |
| Differential | |||
| Pressure | |||
| (Delta P) EN | |||
| 14683:2019+ | |||
| AC: 2019 | 3.7 mmH2O/cm2 | 4.2 mmH2O/cm2 | Similar |
| Flammability | |||
| 16CFR 1610 | Class 1 | Class 1 | Same |
| Cytotoxicity | Non cytotoxic | Non cytotoxic | Same |
| Irritation | Non irritating | Non irritating | Same |
| Sensitization | Non sensitizing | Non sensitizing | Same |
Table 1: General Comparison
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Issue 1: The design feature of the proposed device is covered by the predicate device.
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lssue 2: The size of the proposed device is the same as that of the predicate device, but the tolerance range is different, and this difference will not cause new safety risks.
lssue 3: The nose piece of the proposed device is made by polypropylene and iron, which of the predicate device is made by Malleable aluminum wire. The Nose piece is between the inner and outer layers of the mask, which does not contact with the human body directly when used. Moreover, the whole product has been tested for biocompatibility, and the test results confirm that they have good biocompatibility, so their differences will not cause new safety risks.
lssue 4: The Ear loops of the proposed device are made by spandex, which of the predicate device is made by polyester. Both of these materials are commonly used for mask straps. In addition, the proposed devices have been tested for biocompatibility, and the test results confirm that they have good biocompatibility, so their differences will not cause new safety risks.
8. Non-clinical Testing
The purpose of non-clinical testing is to evaluate whether the face mask in accordance with the requirements of technical specification.
Non clinical tests were conducted and conformed to the following standards and the requirements state in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 05, 2004.
Standards:
- ASTM F2100-19 Standard Specification For Performance of Materials used in Medical Face Masks.
- ASTM F1862-13 Standard Test Method For Resistance of Medical Face Masks to Penetration by Synthetic Blood.
- ASTM F2299-03 Stand Test Method For Determining The Initial Efficiency Of Materials Used In Medical Face Masks To Penetration By Particulates Using Latex Spheres.
- 16 CFR 1610 Standard For The Flammability Of Clothing Textiles.
- ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier ● Systems for Medical Devices.
- ANSI/AAMI/ISO 11135:2014 Sterilization of health care products - Ethylene oxide - Requirements for Development, validation, and routine control of a sterilization process for Medical devices
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity.
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices – Part 10: Tests For Irritation And Skin Sensitization.
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| Items | Acceptance criteria | Results |
|---|---|---|
| Fluid Resistance | ||
| Performance | ||
| (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 32 out of 32 pass at 120 mmHg |
| Particulate Filtration | ||
| Efficiency | ||
| (ASTM F2299) | $\ge$ 98% | 99.8% |
| Bacterial Filtration | ||
| Efficiency | ||
| (ASTM F2101) | $\ge$ 98% | 99.9% |
| Differential Pressure | ||
| (EN 14683:2019) |