(145 days)
Not Found
No
The device description and performance studies focus on material properties and filtration efficiency, with no mention of AI or ML.
No
The device is a medical face mask intended to protect against transfer of microorganisms and particulate material, not for treating a disease or condition.
No
The provided text explicitly states the intended use of the Medical Face Masks is to "protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material" and for "infection control practices to reduce the potential exposure to blood and body fluids." There is no mention of the device being used for diagnosis, detection, or monitoring of any medical condition.
No
The device description clearly indicates it is a physical face mask made of multiple layers of non-woven fabric, not software.
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 individuals from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask related to filtration, fluid resistance, and breathability. These are not studies related to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information.
In summary, the device is a physical barrier intended for personal protection, not a diagnostic tool used to test samples from the body.
N/A
Intended Use / Indications for Use
The 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 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 Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric.
The Medical Face Masks are single use, disposable device, provided non-sterile.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance tests were conducted to verify that the proposed device met all design specifications. The tests performed include:
- Fluid Resistance Performance (ASTM F1862M-17): 29 out of 32 samples passed at 120mmHg.
- Particulate Filtration Efficiency (ASTM F2299): Average 99.82% at 0.1μm.
- Bacterial Filtration Efficiency (ASTM F2101-19): Average 99.78%.
- Differential Pressure (EN 14683:2019 Annex C): Average 3.3 mmH2O/cm².
- Flammability (16 CFR 1610): Met Class I (Non Flammable).
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: 29 out of 32 samples passed at 120mmHg.
Particulate Filtration Efficiency: Average 99.82% at 0.1μm.
Bacterial Filtration Efficiency: Average 99.78%.
Differential Pressure: Average 3.3 mmH2O/cm².
Flammability: Class I Non Flammable.
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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February 3, 2021
Guilin HBM Sanitary Protections, Inc % 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: K202627
Trade/Device Name: Medical Face Masks Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 9, 2020 Received: November 13, 2020
Dear 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.
For CAPT Elizabeth Claverie, M.S. 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
2
Indications for Use
510(k) Number (if known) K202627
Device Name Medical Face Masks
Indications for Use (Describe)
The 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 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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510(k) Summary: K202627
I. Submitter
Guilin HBM Sanitary Protections, Inc No.1-2, Shuijing East Road, Economic and Technological Development Area, Guilin 541805, China Contact person: Liu Xin Position: General Manager Assistant Tel.: +86-13761713489 E-mail: 724095871@qq.com
Preparation date: Jan.30, 2021
Submission Correspondent
Ms. Shelley Li Tel.: +86-021-80317637 Shanghai Landlink Medical Information Technology Co., Ltd. E-mail: shelley.li@landlink-healthcare.com
II. Proposed Device
| Trade Name of Device: | Medical Face Masks |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel | General Hospital |
III. Predicate Devices
| 510(k) Number: | K153496 |
|---|---|
| Trade name: | Disposable Surgical Face Mask |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | Xiantao Rayxin Medical Product Co., Ltd |
IV. Device description
4
The Medical Face Masks are Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose. The Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric. The middle layer with filtration function is made of melt blown polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric.
The Medical Face Masks are single use, disposable device, provided non-sterile.
V. Indication for use
The 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 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.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device
(K202627) | Predicate device
(K153496) | Comparison | |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Medial Face Masks | Disposable Surgical
Face Mask | Similar | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | Class II | Class II | Same | |
| Mask style | Flat-pleated, ear loop,
3 layers | Flat-pleated, ear loop,
tie-on, 3 Layers | Similar | |
| Indication for use | The 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. | 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 | Same | |
| | | 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. | 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. | |
| Materials | Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Ear loop | 85% Spandex + 15% Polyester | Polyester | Different1 |
| | Nose piece | Iron wire covered polypropylene | Malleable aluminum wire | Different1 |
| Color | | Blue | Blue | Same |
| Length | | 17.5cm | 17.5±1cm | Same |
| Width | | 9.5cm | 9.5±1cm | Same |
| OTC use | | Yes | Yes | Same |
| Sterile | | Non-sterile | Non-sterile | Same |
| Single for use | | Yes | Yes | Same |
| Biocompatibility | | Confirm to the requirements of ISO 10993 series standards | Confirm to the requirements of ISO 10993 series standards | Same |
| Fluid Resistance Performance
ASTM E1862 | | Pass at 120mmHg | pass at 120mmHg | Similar |
| Particulate
Filtration Efficiency
ASTM F2299 | Average 99.82% at
0.1μm | Average 99.74% at
0.1μm | | |
| Bacterial Filtration
Efficiency
ASTM F2101 | Average 99.78% | Average 99.4% | | |
| Differential
Pressure | Average 3.3
mmH2O/cm² | Average 2.7
mmH2O/cm² | | |
| Flammability
16 CFR 1610 | Class I
Non Flammable | Class 1
Non Flammable | | |
| In Vitro
Cytotoxicity
ISO 10993-5 | Under the conditions
of this study the
device is
non-cytotoxic | Under the conditions
of this study the
device is
non-cytotoxic | Same | |
| Skin Irritation
ISO 10993-10 | Under the conditions
of this study the
device is non-irritating | Under the conditions
of this study the
device is non-irritating | Same | |
| Skin Sensitization
ISO 10993-10 | Under the conditions
of this study the
device is
non-sensitizing | Under the conditions
of this study the
device is
non-sensitizing | Same | |
Table 1 Comparison of characteristics
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6
1 The difference in the materials does not raise additional questions for safety and effectiveness of the device. The biocompatibility evaluation test of the subject devices have been performed on the final finished device which includes all construction materials and color additives. The test results shows pass the requirements.
VII. Summary of Non-Clinical Testing
Non-clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the related standards:
| Methodology/
Standard | Purpose | Acceptance
Criteria | Results |
|--------------------------|---------------------------------|---------------------------------|-------------------------|
| ASTM
F1862M-17 | Fluid Resistance
Performance | 29 out of 32 pass at
120mmHg | 29 out of 32
pass at |
7
| 120mmHg | |||
|---|---|---|---|
| ASTM F2299 | Particulate Filtration Efficiency | ≥98% | Average |
| 99.82% at | |||
| 0.1μm | |||
| ASTM | |||
| F2101-19 | Bacterial Filtration Efficiency | ≥98% | Average |
| 99.78% | |||
| EN 14683:2019 | |||
| Annex C | Differential Pressure |