(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a face mask, with no mention of AI or ML.
No.
The device's intended use is to protect from the transfer of microorganisms, body fluids, and particulate material, not to treat or cure a disease or condition.
No
The device is a protective face mask intended to prevent the transfer of microorganisms, body fluids, and particulate material. It does not analyze patient data or provide medical diagnoses.
No
The device description clearly outlines physical components like spun-bond polypropylene, melt-blown polypropylene, non-woven polypropylene filters, spandex, polyester, and aluminum, indicating it is a hardware device.
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 against the transfer of microorganisms, body fluids, and particulate material by being worn on the face. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction and materials of a face mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, fluid resistance, flammability) and its biocompatibility when in contact with the skin. These are not studies related to the accuracy or reliability of a diagnostic test.
- Key Metrics: The key metrics are related to the mask's ability to filter particles and fluids, not to the detection or measurement of substances in a biological sample.
IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening. This face mask does not perform any such function.
N/A
Intended Use / Indications for Use
The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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, provided non-sterile.
Product codes
FXX
Device Description
The Protective Face Mask for Medical Use is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color.
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
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance testing:
- Fluid Resistance Performance (ASTM F1862M-17): 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency (ASTM F2299): 99.22%
- Bacterial Filtration Efficiency (ASTM F2101-19): 99.89%
- Differential Pressure (EN 14683:2019 Annex C): 4.2 mmH2O/cm²
- Flammability (16 CFR 1610): Class 1 (not ignited)
Biocompatibility testing:
- Cytotoxicity (ISO 10993-5:2009): Pass (Non-Cytotoxic)
- Irritation (ISO 10993-10:2010): Pass (Non-Irritating)
- Sensitization (ISO 10993-10:2010): Pass (Non-Sensitizing)
No clinical study is included in this submission.
Key Metrics
- Fluid Resistance Performance: 32 out of 32 pass at 120mmHg
- Particulate Filtration Efficiency: 99.22%
- Bacterial Filtration Efficiency: 99.89%
- Differential Pressure: 4.2 mmH2O/cm²
- Flammability: 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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September 4, 2020
Shandong Shengquan New Material Co., Ltd. % Shelley Li Director Shanghai Landlink Medical Information Technology Co., Ltd. Room 703, 705, Baohua International Plaza West Guangzhong Road 555, Jingan Shanghai 200071 China
Re: K201537
Trade/Device Name: Protective Face Mask for Medical Use Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 4, 2020 Received: June 8, 2020
Dear Ms. Shelley Li:
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.
1
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 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.
Elizabeth Claverie, MS 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) K201537
Device Name Protective Face Mask for Medical Use
Indications for Use (Describe)
The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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, provided non-sterile.
| 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) |
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
I. Submitter
Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhanggiu District, Jinan 250204 Shandong, China. Establishment Registration Number: 3016688828
Contact person: Xiumei Zhang Position: QC Manager Tel.: +86-13864136816 Fax: +86-21-34622840 E-mail: zhangxiumei@shengquan.com Preparation date: Sept. 02, 2020
II. Proposed Device
| Trade Name of Device: | Protective Face Mask for Medical Use |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel | General Hospital |
III. Predicate Device
| 510(k) Number: | K143287 |
|---|---|
| Trade name: | FLUIDSHIELD Surgical Mask with Expanded Chamber |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Halyard Health, Inc. |
IV. Device description
The Protective Face Mask for Medical Use is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use.
4
The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.
The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a malleable aluminum strip covered with sponge, which is welded to the facemask top edge to allow the user to fit the facemask around their nose. The mask is a single use, disposable device, provided non-sterile in white color
V. Indication for use
The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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, provided non-sterile.
VI. Comparison of technological characteristics with the predicate device
| Item | Proposed device | Predicate device
(K143287) | Comparison |
|--------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Protective Face Mask for
Medical Use | FLUIDSHIELD Surgical Mask
with Expanded Chamber | - |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Mask style | Expanded chamber
flat-folded, ear loops,
4 layers | Expanded chamber (Duckbill)
flat-folded, headband ties,
4 layers | Similar |
| Indication for use | The Protective Face Mask
for Medical Use is intended
to be worn to protect both
the patient and healthcare
personnel from transfer of
microorganisms, body fluids
and particulate material.
The face mask is intended | The Expanded Chamber
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. These
face masks are intended for | Same |
Table 1: General Comparison
5
| Material | | | 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. | 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. | |
|----------|------------------|----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | | Inner layer | Spun-bond polypropylene | Polyethylene/Polyester | Different |
| | | Middle layer | polypropylene non-woven
fabric | Spun-bond polypropylene | Different |
| | | Outer layer | Melt-blown polypropylene | Melt-blown polypropylene | Same |
| | | | Spun-bond polypropylene | Top Half: Blue spun-bond
polypropylene (w Print)
Bottom Half: White spun-bond
polypropylene | Similar |
| | | Ear
loop/headband | Spandex + Polyester | Polyester spunlace or
spun-bond polypropylene | Similar |
| | | Nose piece | Plastic coated aluminum
wire covered with sponge
strips | Unknown | |
| | Color | | White outer layer and gray
inner layer | Top Half: Blue
Bottom Half: White | Different |
| | Size | | Length: 16.5±0.8cm
Width: 10.5±0.5cm | Length: 21.0±1.0 cm
Width: 19.0± 0.3 cm | Different |
| | OTC use | | Yes | Yes | Same |
| | Sterility | | Non-sterile | Non-sterile | Same |
| | Use | | Single use, disposable | Single use, disposable | Same |
| | ASTM F2100 Level | | Level 2 | Level 2 | Same |
VII. Non-Clinical Testing
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks -Premarket Notification [510(k)] Submission issued on March 5, 2004.
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Table 2: Performance testing
| Test Items | Acceptance Criteria | Results |
|---|---|---|
| Fluid Resistance Performance | 29 out of 32 pass | 32 out of 32 pass |
| ASTM F1862M-17 | at 120 mmHg | at 120mmHg |
| Particulate Filtration Efficiency | ||
| ASTM F2299 | >98% | 99.22% |
| Bacterial Filtration Efficiency | ||
| ASTM F2101-19 | >98% | 99.89% |
| Differential Pressure | ||
| EN 14683:2019 Annex C |