(446 days)
Not Found
No
The device description and performance studies focus on the physical filtration properties and biocompatibility of a surgical face mask, with no mention of AI or ML.
No
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical face mask, which primarily provides a barrier to protect against the transfer of microorganisms and fluids, rather than directly treating a condition.
No
Explanation: The "Intended Use" states that the device is "intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material." It is designed for protection, not for diagnosing any condition.
No
The device description clearly states it is a physical surgical face mask made of materials like polypropylene and PVC, with ear loops and a nose piece. It is a tangible, disposable hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of a face mask, including layers, ear loops, and a nose piece. There is no mention of reagents, samples (like blood, urine, etc.), or any components used for analyzing biological specimens.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability) and biocompatibility (irritation, sensitization, cytotoxicity). These are relevant to a physical barrier device, not an IVD.
- Lack of IVD Indicators: There is no mention of analyzing samples, detecting analytes, or providing diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Surgical Face Masks are is 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.
Product codes
FXX
Device Description
The Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PVC wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks 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
healthcare personnel
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
Fluid Resistance Performance (ASTM F1862): 3 non-consecutive lots tested, 29 out of 32 pass at 120 mmHg. Result: Pass.
Particulate Filtration Efficiency (ASTM F2299): 3 non-consecutive lots tested (Lot1: 99.64%, Lot2: 99.70%, Lot3: 99.63%). Acceptance Criteria: >= 98%. Result: Pass.
Bacterial Filtration Efficiency (ASTM F2101): 3 non-consecutive lots tested (Lot1: 99.6%, Lot2: 99.8%, Lot3: 99.4%). Acceptance Criteria: >= 98%. Result: Pass.
Differential Pressure (Delta P) (MIL-M-36954C): 3 non-consecutive lots tested (Lot1: 3.4mmH2O/cm², Lot2: 3.2mmH2O/cm², Lot3: 3.4mmH2O/cm²). Acceptance Criteria: = 98%)
Bacterial Filtration Efficiency: Lot1: 99.6%, Lot2: 99.8%, Lot3: 99.4% (Acceptance Criteria: >= 98%)
Differential Pressure (Delta P): Lot1: 3.4mmH2O/cm², Lot2: 3.2mmH2O/cm², Lot3: 3.4mmH2O/cm² (Acceptance Criteria:
§ 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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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in blue. The word "ADMINISTRATION" is written below "U.S. FOOD & DRUG".
December 13, 2021
Jiande Chaomei Daily Chemicals Co., Ltd Sam Lin Official Correspondent Shanghai Spica Management Consulting Co., Ltd. 609Room, NO.133 Shengang Avenue, Pudong New District Shanghai, 200120 China
Re: K202794
Trade/Device Name: Surgical Face Mask: F-Y1-A Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 26, 2021 Received: November 26, 2021
Dear Sam Lin:
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 (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.
For Clarence W. Murray III, PhD 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
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Indications for Use
510(k) Number (if known) K202794
Device Name Surgical face mask: F-Y1-A
Indications for Use (Describe)
The Surgical Face Masks are is 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)
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| Type of submission | Traditional |
|---|---|
| Date prepared | May 1, 2021 |
| Submission sponsor | |
| Manufacturer Name | Jiande Chaomei Daily Chemicals Co., Ltd. |
| Address | Shangshan Village, Yancunqiao Town, Jiande City, Zhejiang |
| Province, China | |
| Tel | 86-18858158190 |
| zhuliping@cmmask.com | |
| Contact Person | Zhu Lipin |
| Device identification | |
| Classification Name | Mask, Surgical |
| Trade Name | Surgical face mask: F-Y1-A |
| Device Classification | Class II |
| Regulation Number | 21 CFR 878.4040 |
| Panel | General Hospital |
| Product Code | FXX |
| Previous Submissions | None |
| Application correspondent | |
| Company Name | Shanghai Spica Management Consulting Co., Ltd. |
| Address | 609 Room, No.133 Shengang Avenue, Pudong New District, |
| Shanghai, China | |
| Tel | 86-15626132181 |
| sam@spicagloble.com | |
| Contact Person | Sam Lin |
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Predicate device information
| Sponsor | WUHAN DYMEX HEALTHCARE CO., LTD. |
|---|---|
| Trade/Device Name | SURGICAL FACE MASK |
| 510(K) number | K182515 |
| Regulation Number | 21 CFR 878.4040 |
Indications for use
The Surgical Face Masks are is 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 description
The Surgical Face Masks are single use, three-layer, flat -folded masks with ear loops and nose piece. The Surgical Face Masks are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of PVC wrapped with metal wire. The surgical face masks will be provided in blue. The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Technological Characteristic Comparison
Provided below is a comparison of the subject device with the predicate device.
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| Table 6A: General Comparison | ||
|---|---|---|
| Proposed Device | Predicate Device | Differences | ||
|---|---|---|---|---|
| Discussion | ||||
| Device name | Surgical face mask: F-Y1-A | SURGICAL FACE MASK | N/A | |
| 510(k) number | K202794 | K182515 | N/A | |
| Manufacturer | Jiande Chaomei Daily Chemicals Co., Ltd. | Wuhan Dymex Healthcare Co., Ltd | N/A | |
| Product regulation | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Classification name | Mask, Surgical | Mask, Surgical | Same | |
| Regulation class | Class II | Class II | Same | |
| Product code | FXX | FXX | Same | |
| Indications for use | 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. | 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 | |
| Rx or OTC | OTC | OTC | Same | |
| Model | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Flat Pleated, 3 layers | Same | |
| Material | Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | PVC wrapped with metal wire | Malleable polyethylene wire | Similar | |
| Ear loops | Low elastic spandex yarn | Spandex | Similar | |
| Color | Blue | Yellow | Similar | |
| Dimension(Width) | 17.5cm±0.5cm | 17.5cm±0.2cm | Same | |
| Dimension(Length) | 9.0cm±0.2cm | 9.5cm±0.2cm | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
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Summary of Non-Clinical Testing: provided below is a summary of the subject devices to demonstrate that the device meets the specification or acceptance criteria of the standards and test methods shown below.
| Item | Proposed device | Acceptance Criteria | Result | ||
|---|---|---|---|---|---|
| Fluid Resistance Performance | |||||
| ASTM F1862 | 3 non-consecutive lots tested | 29 out of 32 pass at 120 mmHg | Pass | ||
| Particulate Filtration Efficiency | |||||
| ASTM F2299 | 3 non-consecutive lots tested | ||||
| Lot1: 99.64% | |||||
| Lot2: 99.70% | |||||
| Lot3: 99.63% | ≥ 98% | Pass | |||
| Bacterial Filtration Efficiency | |||||
| ASTM F2101 | 3 non-consecutive lots tested | ||||
| Lot1: 99.6% | |||||
| Lot2: 99.8% | |||||
| Lot3: 99.4% | ≥ 98% | Pass | |||
| Differential Pressure (Delta P) | |||||
| MIL-M-36954C | 3 non-consecutive lots tested | ||||
| Lot1: 3.4mmH2O/cm² | |||||
| Lot2: 3.2mmH2O/cm² | |||||
| Lot3: 3.4mmH2O/cm² |