(124 days)
None
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
Explanation: The device is described as a surgical face mask intended to protect from the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not designed to treat, cure, mitigate, or prevent disease or affect the structure or any function of the body, which are characteristics of a therapeutic device.
No
The device is a surgical face mask, designed to prevent the transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layer face mask made of nonwoven and melt blown fabrics with ear loops or ties and a nose piece. The performance studies focus on physical properties and material biocompatibility, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It's a physical barrier for infection control.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops/ties, nose piece).
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, pressure resistance, blood penetration, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). These are tests related to the mask's function as a physical barrier and its safety for contact with skin.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment. IVDs typically involve reagents, instruments, or systems used to perform tests on these specimens.
This device is a surgical face mask, which is a medical device but falls under a different regulatory classification than IVDs.
N/A
Intended Use / Indications for Use
Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 mask is single use, three-layer, flat-pleated style with ear loops/ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The ear straps/ear loops are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Poly Ethylen. The Surgical face mask will be provided in blue. The 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
Non-clinical testing was performed.
Performance Testing:
Items: Bacterial filtration efficiency (BFE) (%), Different pressure (mmH2O/cm²), Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE), Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result, Flammability.
Acceptance Criteria (Level 3, ASTM F2100-19):
- BFE: >=98
- Different pressure: =98
- Resistance to penetration by synthetic blood: 29 of 32 test articles passed at 160mmHg
- Flammability: Class 1
Results: - BFE: 99.3-99.7% Pass
- Different pressure: 2.9-3.8 mmH2O/cm² Pass
- PFE: 99.74-99.90% Pass
- Resistance to penetration by synthetic blood: 32 of 32 test articles passed at 160mmHg; Pass
- Flammability: Class 1, Non Flammable Pass
Biocompatibility Testing:
Study type: Cytotoxicity, Irritation, Sensitization
Results:
- Cytotoxicity: Under the conditions of the study, the device is noncytotoxic. Pass
- Irritation: Under the conditions of the study, the device is nonirritating. Pass
- Sensitization: Under the conditions of the study, the device is nonsensitizing. Pass
Key Metrics
- Bacterial filtration efficiency (BFE) (%)
- Different pressure (mmH2O/cm²)
- Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
July 19, 2022
Hubei Qianjiang Kingphar Medical Material Co., Ltd % Mr. Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, Number 738, Shangcheng Road, Pudong Shanghai 200120 China
Re: K220777
Trade/Device Name: Surgical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 20, 2022 Received: June 27, 2022
Dear Mr. Wang:
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 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,
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220777
Device Name Surgical face mask
Indications for Use (Describe)
Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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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510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's information
Name: Hubei Qianjiang Kingphar Medical Material Co., Ltd Address: Yuanguang Road, 433100 Qianjiang, People's Republic of China Phone Number: +86-13349716939 Contact: Zhao Fusong Date of Preparation: 04/03/2022
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Surgical face mask Common name: Surgical face mask Classification name: Mask, Surgical Model(s): Ear loop/Tie on, 175×95mm
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Device: Disposable Surgical Face Mask 510(k) number: K153496
5.0 Indication for Use Statement
Surgical face mask is intended to be worn to protect both the patient and healthcare
4
personnel from transfer of microorganisms, body fluids and particulate material. It is 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.
6.0 Device description
The Surgical face mask is single use, three-layer, flat-pleated style with ear loops/ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics.
The model of proposed device, tie-on, is held in place over the uers's mouth and nose by four ties welded to the facemask. The tie is made of spun-bond polypropylene.
The model of proposed device, ear loops, is held in place over the uers's mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex.
The ear straps/ear loops are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of Poly Ethylen. The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
| Item | Proposed device | Predicated device | Comparison | |
|---|---|---|---|---|
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| 510(k) No. | K220777 | K153496 | - | |
| Models | ear loop/Tie on, 175×95mm | Ear Loops, Tie-On, Flat Pleated, | ||
| 3 layers | - | |||
| Intended Use | The Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It is 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 | |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Similar | |
| Internal | ||||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
7.0 Technological Characteristic Comparison Table
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510(k) Summary
| Material | Middle layer | Melt blown polypropylene | Melt blown polypropylene | Similar |
|---|---|---|---|---|
| External | ||||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar | |
| Nose piece | Poly Ethylen | Malleable polyethylene | ||
| wire | * Gap 1 | |||
| ear strap | Polyester | Polyester | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | ||||
| Dimension (Width) | 17.5cm±0.5cm | |||
| 9.5cm±0.5cm | 17.5cm±1cm | |||
| 9.5cm±1cm | * Gap 2 |
The proposed and predicate devices are based on the following same technological elements,
- Structures and dimensions
- Components materials
- Colors
- Sterility
- Single use
- ASTM F2100 level
The following technological differences exist between the proposed and predicate devices:
Gap 1: the two devices have some difference in materials of nose piece and ear straps of Tie-on models.
Gap 2: the two devices share same dimensions but the tolerance is different, the little deviation in tolerance.
Gap 3: the proposed device has higher performance level (Level 3) higher than the predicate device, the higher performance does not bring additional risks to the device. Gap 4: the predicate device does not claim specific shelf life while the proposed device define its 5 years shelf life which is proved by its shelf life performance study, the clear shelf life does not bring additional risks to the product use.
8.0 Clinical Test Conclusion
No clinical study implemented for the Surgical face mask.
9.0Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
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| Items | Purpose | Acceptance Criteria
(Level 3, ASTM
F2100-19) | Result |
|-------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------|
| Bacterial filtration
efficiency (BFE) (%) | The purpose of
the test is to
evaluate the
Bacterial filtration
efficiency (BFE)
(%) | ≥98 | 99.3-99.7%
Pass |
| Different pressure
(mmH2O/cm²) | The purpose of
the test is to
evaluate the
Different pressure
(mmH2O/cm²) |