(164 days)
Not Found
No
The device description and performance studies focus on the physical filtration and material properties of a standard medical face mask, with no mention of AI/ML capabilities or related data/training sets.
No.
The device description and intended use clearly state that the masks are for protection against transfer of microorganisms and particulate material, and for infection control, not for treating any specific disease or condition.
No
The device is a medical face mask, intended to protect from transfer of microorganisms and fluids, not to diagnose a condition.
No
The device is a physical medical device (face mask) composed of materials like polypropylene and galvanized iron wire, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Intended Use: The intended use of the Disposable Medical Face Masks is to be worn on the face to protect against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample.
- Device Description: The description details the physical components of the mask (layers, ear loops, nose piece). It does not describe any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties of the mask as a barrier (filtration efficiency, fluid resistance, flammability) and its biocompatibility when in contact with skin. These are not diagnostic performance metrics.
The device is a personal protective equipment (PPE) intended for use in infection control, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The Disposable 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face / mouth, nose
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Healthcare personnel, patient
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)
Summary of Non-Clinical Performance Test
- Bacterial Filtration Efficiency: Test Method: ASTM F2101 Standard Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus. Pass Criteria: ≥98%. Test Results: Pass.
- Differential Pressure (Delta-P): Test Method: EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019. Pass 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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July 12, 2021
Suzhou Bolisi Medical Technology Co., Ltd % Ryan Li RA Manager Shanghai Mind-link Business Consulting Co., Ltd. Room A08, Floor 14th, No 699, Jiaozhou Road, Jingan District Shanghai. 200040 China
Re: K210244
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 7, 2021 Received: June 10, 2021
Dear Ryan 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.
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,
Ryan Ortega, PhD Acting Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Disposable Medical Face Mask(145mm95mm). Blue. Ear Loop type Disposable Medical Face Mask(175mm95mm), Blue, Ear Loop type
Indications for Use (Describe)
The Disposable 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. The Disposable Medical Face Masks are 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-K210244
I. SUBMITTER:
Suzhou Bolisi Medical Technology Co.,Ltd Baijiaqiao industrial community, Yangshe Town, Zhangjiagang City, Jiangsu Province, China Contact Person: Hong Xu Title: General Manager Tel: +86 13776246881 Email: zjgbolisi@163.com
Submission Correspondent: Ryan Li Email: ryan.li@mind-link.net Tel:+86 13701581791
Summary prepared: June 28, 2021
II. DEVICE
Name of Device: Disposable Medical Face Mask Regulation Number: 21 CFR PART 878.4040 Common Name: Surgical Mask Classification Name: Surgical Mask Regulatory Class: II Product Code: FXX
III. PREDICATE DEVICE
Predicate: K210007
Trade/Device Name: Face Mask
Manufacturer: Jinhua Jingdi Medical Supplies Co.,Ltd
Product Code: FXX
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Classification Name: Mask, surgical
Regulation Number: 21 CFR 878.4040
IV. DEVICE DESCRIPTION
Disposable Medical Face Mask is composed of three layers and is flat-pleated. The mask materials consist of an outer layer (spun-bond polypropylene), a middle layer, between the outer layer and inner layers (melt-blown polypropylene), and an inner layer (Spun-bond polypropylene). Each mask contains ear loops to secure the mask over the users' mouth and face and includes a malleable nose piece (galvanized iron wire) to provide a firm fit over the nose.
V. AVAILABLE MODELS
The Disposable Medical Face Masks are available in two models including different sizes.
For the 145mm95mm model is in blue, barrier level 2 and size 145mm95mm, ear loop type.
For the 175mm95mm model is in blue, barrier level 2 and size 175mm95mm, ear loop type.
VI. INDICATIONS FOR USE
The Disposable 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VII. THE PREDICATE DEVICE
The Disposable Surgical Masks are compared with the predicate device (Face Mask (K210007)). The results are shown below in the Technological Characteristics Comparison Table:
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| DEVICE | Subject Device | Primary Predicate Device | Comparison |
|---|---|---|---|
| Disposable Medical Face Mask | Face Mask (K210007 ) | ||
| Intended Use | The Disposable 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. The Disposable Medical Face Masks are single use, disposable device, provided non-sterile. | The face mask 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. The face mask is a single-use, disposable device, provided non-sterile. | Same |
| Classification | FXX | FXX | Same |
| Product Code | |||
| Ear Loop Model | Ear Loops | Ear Loops | Same |
| Materials | |||
| Outer Layer | Facing Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene non-woven fabric | Similar Note 1 |
| Middle Layer | Melt-blown polypropylene | Melt-blown polypropylene | Similar Note 1 |
| Inner Layer | Facing Spun-bond polypropylene non-woven fabric | Spun-bond polypropylene non-woven fabric | Similar Note 1 |
| Nose Piece | Galvanized iron wire | Iron wire covered polypropylene | Different Note 1 |
| Ear Loops | 82% Spandex | ||
| 18% Polyester | 75% Polyester | ||
| 25% Spandex | Similar Note 1 | ||
| Design Features | |||
| Color | Blue | Blue | Same |
| Style | Flat - Pleated | Flat - Pleated | Same |
| Multiple Layers | 3 Layers | 3 Layers | Same |
| Single Use | Single use | Single use | Same |
| Sterility | |||
| Sterile | Non-sterile | Non-sterile | Same |
| Dimensions | |||
| Length × Width | $145\times95$ mm (±5mm) | ||
| $175\times95$ mm (±5mm) | $145\times95$ mm (±5mm) | ||
| $175\times95$ mm (±5mm) | Same | ||
| Technological Characteristics Product Barrier Specifications Per ASTM F2100 – Meets Level 2 | |||
| Fluid Resistance | |||
| ASTM F1862 | 32 out of 32 Pass at 120mmHg | 32 out of 32 pass at 120mmHg | Same |
| Particulate | |||
| Filtration | |||
| Efficiency (PFE) | |||
| ASTM F2299 | Pass at ≥98% | Pass at 99.70% | Similar |
| Note 2 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency (BFE) | |||
| ASTM F2101 | Pass at ≥98% | Pass at 99.95% | Similar |
| Note 2 | |||
| Differential | |||
| Pressure (Delta | |||
| P)MIL-M-36954C | Pass at $ |