(93 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
The device is a disposable surgical mask intended for protection from microorganisms and fluids, not for treating a disease or condition.
No
The device is a surgical mask intended for protection against microorganisms and fluids, not for diagnosing medical conditions.
No
The device description clearly outlines a physical product made of materials like polypropylene, polyamide fibers, spandex, and iron wire. It is a tangible, disposable surgical mask, not a software application.
Based on the provided information, 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 from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, test strips, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such analysis.
- Performance Studies: The performance studies focus on the physical properties of the mask as a barrier (fluid resistance, filtration efficiency, breathability, flammability). These are relevant to its function as a protective covering, not as a diagnostic tool.
Therefore, the Disposable Surgical Mask described is a medical device, but it falls under the category of a personal protective equipment (PPE) or a barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical 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(s), provided non-sterile.
Product codes
FXX
Device Description
Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which 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 face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nose and mouth
Indicated Patient Age Range
Adults
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 performed on the proposed device.
Performance Characteristics Test Methods and Results:
- Fluid Resistance Performance: ASTM F1862, 31 out of 32 pass at 120mmHg, Acceptance Criteria: 29 out of 32 pass at 120mmHg. Result: Pass.
- Particulate Filtration Efficiency: ASTM F2299, 99.7%, Acceptance Criteria: ≥ 98%. Result: Pass.
- Bacterial Filtration Efficiency: ASTM F2101, 99.5%, Acceptance Criteria: ≥ 98%. Result: Pass.
- Differential Pressure (Delta-P): MIL-M-36954C, 4.24mmH2O/cm², Acceptance 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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Image /page/0/Picture/0 description: The image shows 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 15, 2021
Heilongjiang Yinjia Medical Equipment Co., Ltd. % Doris Dong Manager Shanghai CV Technology Co., Ltd. Room 903, No.19 Dongbao Road, Songjiang Area Shanghai, Shanghai 201613 China
Re: K212944
Trade/Device Name: Disposable Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 2, 2021 Received: September 13, 2021
Dear Doris Dong:
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) K212944
Device Name Disposable Surgical Mask
Indications for Use (Describe)
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical 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(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 [As required by 21 CFR 807.92]
| 1. Submission Information: | |
|---|---|
| 510(k) Number: | K212944 |
| Date: | December 15, 2021 |
| Type of 510(k) Submission: | Traditional |
| Basis for 510(k) Submission: | New device |
| Applicant/Manufacturer: | Heilongjiang Yinjia Medical Equipment Co., Ltd. |
| F3-4, Plant 6, No.10, Hanan 12th Road, Nangang District, Harbin City | |
| Heilongjiang, China 150000 | |
| Contact person: | Doris Dong |
| [Consultant, from Shanghai CV Technology Co., Ltd.] | |
| Add: Room 903, No. 19 Dongbao Road, Songjiang Area, Shanghai, 201613 China | |
| E-mail: doris.d@ceve.org.cn | |
| Tel: 86 21-31261348 / Fax: 86 21-57712250 |
2. Device Description:
| Proprietary Name: | Disposable Surgical Mas |
|---|---|
| Model | Size M, Size S |
| Common Name: | Surgical mask |
| Classification Name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Product Code: | FXX |
| Device Class: | II |
| Review Panel: | General Hospital |
3. Predicatedevice
Surgical Face Mask, K182515
WUHAN DYMEX HEALTHCARE CO., LTD
This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. Device Description
Disposable Surgical Mask, Ear Loop Type, Size M and S is a single use, three-layer, flat-pleated mask with ear loops and a nose piece. The Disposable Surgical Mask is manufactured with three layers, of which 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 face mask. The latex free elastic ear loops are made of polyamide fibers and spandex. The nose piece in the layers of face mask allows the user to fit the face mask around their nose, which is made of core iron wire with halogen-free polyethylene covering. The Disposable Surgical Mask will be provided in blue of outside and white of inside. The Disposable Surgical Mask is provided non-sterile and for single use.
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5. Intended Use/Indication for use
The Disposable Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Surgical 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(s), provided non-sterile.
6. Technological Characteristics Comparison with the predicate device:
Table 1 General comparison
| Device | Proposed device | Predicate device | Comparison | |
|---|---|---|---|---|
| 510(k) Holder | Heilongjiang Yinjia Medical | |||
| Equipment Co., LTD | WUHAN DYMEX | |||
| HEALTHCARE CO., LTD | -- | |||
| 510(k) Number | K212944 | K182515 | -- | |
| Name | Disposable Surgical Mask | Surgical Face Mask | -- | |
| Model | Size M, Size S | / | -- | |
| Classification | Class II Device, FXX (21 CFR | |||
| 878.4040) | Class II Device, FXX (21 CFR | |||
| 878.4040) | Same | |||
| Intended use/ | ||||
| Indications | ||||
| for Use | The Disposable Surgical Mask is | |||
| intended to be worn to protect | ||||
| both the patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body fluids and | ||||
| particulate material. The | ||||
| Disposable Surgical 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(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), providednon-sterile. | Same | |||
| Mask style | Flat Pleated | Flat Pleated | Same | |
| Design | Ear loop | Ear loop | Same | |
| Layers | Three | Three | Same | |
| Dimension | Size M: 175*95mm | |||
| Size S: 140*95mm | 175*95mm | Similar | ||
| Note 1 | ||||
| Color | Blue outside; white inside | Yellow | Different | |
| Note 2 | ||||
| Sterility | Non-sterile | Non-sterile | Same | |
| Target population | Adults | Adults | Same | |
| Use | Single use, disposable | Single use, disposable | Same | |
| Anatomical site | Nose and mouth | Nose and mouth | Same | |
| Technology | Self-suction filter mask | Self-suction filter mask | Same | |
| Environment of | ||||
| use | OTC | OTC | Same | |
| Material | ||||
| Outer facing layer | Spunbond polypropylene | Spunbond polypropylene | Same | |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spunbond polypropylene | Spunbond polypropylene | Same | |
| Ear loops | Polyamide fibers, Spandex | Spandex | Same Note 2 | |
| Nose piece | Core iron wire with polyethylene | |||
| covering | Malleable polyethylene wire | |||
| Colorants | Polypropylene (PP) master batch | Unknown | ||
| ASTM F2100 | Level 2 | Level 2 | Same | |
| Level | ||||
| Biocompatibility (limited contact ( |