(277 days)
Not Found
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
A surgical face mask is for protection and infection control, not for treating or diagnosing a disease or condition.
No
The device is a surgical face mask, an infection control barrier, not a diagnostic tool for identifying diseases or conditions.
No
The device description clearly outlines physical components (three-layer material, ear loops, nose piece) and performance studies relate to physical properties (filtration, pressure, flammability, biocompatibility), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, pressure resistance, flammability, biocompatibility), not on diagnostic accuracy or analytical performance.
This device is a Class II medical device (based on the predicate device K153496, which is a surgical mask) intended for infection control.
N/A
Intended Use / 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, provided non-sterile.
Product codes
FXX
Device Description
The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece.
The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices.
The Surgical 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 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 made of polyester. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
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 on three nonconsecutive lots to demonstrate that the proposed device met all design specifications or acceptance criteria in the standard and test methodology.
Performance Test Result Summary:
- ASTM F2100-19e1 ASTM F2101-19 Bacterial Filtration Efficiency Test (BFE), %: Results Pass (Acceptance Criteria Level 2: >= 98)
- ASTM F2100-19e1 EN 14683:2019+AC:2019(E) Annex C Differential Pressure Test (mm H2O/cm²): Results Pass (Acceptance Criteria Level 2: = 98)
- ASTM F2100- 19e1 ASTM F1862/F1862M-17 Resistance to Penetration by Synthetic Blood Test (minimum pressure in mmHg for pass result): Results Pass (Acceptance Criteria Level 2: 120)
- ASTM F2100-19e1 16 CFR Part 1610-2012 Flammability Test: Results Pass (Acceptance Criteria Level 2: Class 1)
Biocompatibility Testing:
- Cytotoxicity: Under the conditions of the study, the device is noncytotoxic. (Result: Pass)
- Irritation: Under the conditions of the study, the device is nonirritating. (Result: Pass)
- Sensitization: Under the conditions of the study, the device is nonsensitizing (Result: Pass)
Key Results: The nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed predicate device, Xianto Rayxin Medical Products Disposable Surgical Face Mask cleared under K153496.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance ASTM F1862-13: Proposed Device 182 out of 182 pass at 120 mmHg, Predicate Device 32 out of 32 pass at 120 mmHg.
Particulate Filtration Efficiency ASTM F2299: Proposed Device 98.40%, Predicate Device 98.46%.
Bacterial Filtration Efficiency ASTM F2101: Proposed Device 99.86%, Predicate Device 98.70%.
Differential Pressure (Delta P) MIL-M-36954C: Proposed Device 5.3 mmH2O/cm2, Predicate Device 4.2 mmH2O/cm2.
Flammability 16 CFR 1610: Proposed Device Class 1, Predicate Device Class 1.
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 & 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.
December 14, 2021
Chongqing Pa Xijia Biotechnology Co., Ltd. % May Wu Manager of Business Development Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Chenglong Avenue Chengdu, Sichuan 610101 China
Re: K210744
Trade/Device Name: Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 21, 2021 Received: October 29, 2021
Dear May Wu:
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,
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) K210744
Device Name Surgical Mask
Indications for Use (Describe)
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, 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 - K210744
This summary of 510(k) is being submitted in accordance with requirements of the SMDA 21 CFR 807.92.
1. Date of Prenaration: February 28, 2021
Sponsor Identification 2.
Chongqing Pa Xijia Biotechnology Co., Ltd. No. 27-5, Fengsheng Road, Jiulongpo District,Chongqing,China
Contact Person: Zheng Tao Position: Head of Firm Tel: +86-23-68085022
3. Designated Submission Correspondent
Miss. May Wu Sichuan JIULUEHUI Consulting Co., Ltd. Room 1401, Building 4, No. 666, Longcheng Avenue, Chengdu City, Sichuan Province, China Tel: +86-18123234232 Email: consulting(@sc9lh.cn
4. Device Information
Trade name: Surgical Mask Common name: Surgical Face Mask Model: Ear-loop
5. Classification
Production code: FXX Regulation number: 21 CFR 878.4040 Classification: Class II Classification name: Surgical Face Mask Review Panel: Surgical Apparel
Indication for Use Statement 6.
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, provided non-sterile.
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7. Device Descrintion
The Surgical Masks are single use, three-layer, flat-pleated style with ear loops and nose piece.
The Surgical Masks will be provided in blue. The medical face masks are sold nonsterile and are intended to be single use, disposable devices.
The Surgical 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 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 made of polyester. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable aluminum wire.
8. Identification of Predicate Device(s)
Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Disposable Surgical Face Mask Device: 510(k) number: K153496
9. Technological Characteristics Comparison Table
| Table 1 General Comparison | |||
|---|---|---|---|
| Item | Proposed Device | ||
| K210744 | Predicate Device | ||
| K153496 | Comparison | ||
| Product | |||
| Name | Surgical Mask | Disposable Surgical Face | |
| Masks | -- | ||
| Product | |||
| Code | FXX | FXX | Same |
| Regulation | |||
| No. | 21 CFR | ||
| 878.4040 | 21 CFR 878.4040 | Same | |
| Product | |||
| Class | II | II | Same |
| Product | |||
| Code | 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, | |||
| 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 | Same |
Table 1 General Comparison
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| | | | disposable device(s), provided
non-sterile. | |
|------------------------|-------------------------------------------------|------------------------------------|------------------------------------------------|-----------|
| Design
features | Ear Loops, 3 layers | | Ear Loops, Tied-On, 3 layers | Same |
| Mask
Styles | Flat pleated | | Flat pleated | Same |
| Material | Outer
facing
layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| | Middle
layer | Melt blown polypropylene
filter | Melt blown polypropylene filter | Similar |
| | Inner
Facing
layer | Spun-bond polypropylene | Spun-bond polypropylene | Similar |
| | Nose
piece | Malleable aluminum wire | Malleable aluminum wire | Similar |
| | Ear
loops | Polyester | Polyester | Similar |
| Color | Blue | | Blue | Similar |
| Mask Size | M(152mmX70mm),L(175mmX90mm),
XL(180mmX100mm) | | 175mmX90mm | Different |
| OTC use | Yes | | Yes | Same |
| Sterility | Non-Sterile | | Non-Sterile | Same |
| Single Use | Yes | | Yes | Same |
| Sterile | No | | No | Same |
| ASTM
F2100
Level | Level 2 | | Level 2 | Same |
Table2 Performance Characteristic Comparison
| ITEM | Proposed Device | Predicate Device | ASTM F2100
Requirements for
Level 2
Classification | Comparison |
|----------------------------------------------------|------------------------------------|----------------------------------|-------------------------------------------------------------|------------|
| Fluid Resistance
Performance ASTM
F1862-13 | 182 out of 182 pass
at 120 mmHg | 32 out of 32 pass at
120 mmHg | Pass at 120
mmHg* | Similar |
| Particulate Filtration
Efficiency
ASTM F2299 | 98.40% | 98.46% | ≥ 98%* | Similar |
| Bacterial Filtration
Efficiency ASTM F2101 | 99.86% | 98.70% | ≥ 98%* | Similar |
| Differential Pressure
(Delta P)
MIL-M-36954C | 5.3 mmH2O/cm2 | 4.2 mmH2O/cm2 |