(189 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No
The device, a disposable medical face mask, is intended for protection by preventing the transfer of microorganisms and fluids, not for treating any medical condition or disease.
No
The device is a medical face mask, intended to protect from microorganisms and fluids. It does not provide any diagnosis of a condition.
No
The device description clearly indicates it is a physical face mask made of non-woven fabrics, 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 against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, samples, or any components used for analyzing biological specimens.
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) to provide information about a person's health, diagnose conditions, or monitor treatment. This face mask does none of those things.
The device is a medical device, specifically a personal protective equipment (PPE) device, but it does not fit the definition of an In Vitro Diagnostic device.
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. This is a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The Disposable 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 Disposable Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric with blue color. 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 with white color. The Disposable 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
Non clinical tests were conducted to verify that the proposed device met all design specifications as the predicate device. The test results demonstrated that the proposed device complies with the following standards:
- ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For . In Vitro Cytotoxicity
- ISO 10993-10: 2010 Biological Evaluation Of Medical Devices Part 10: Tests . For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification for Performance of Materials Used In ● Disposable Surgical Mask.
- ASTM F1862M-17, Standard Test Method For Resistance Of Disposable . Surgical Mask To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019 Medical Face Masks-Requirements and Test Methods ●
- ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration . Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus;
- ASTM F2299-03, Stand test method for determining the initial efficiency of . materials used in Disposable Surgical Mask to penetration by particulates using latex spheres;
- 16 CFR 1610, Standard for the Flammability of clothing textiles; .
Key Metrics
Fluid Resistance Performance ASTM F1862: Pass at 120mmHg
Particulate Filtration Efficiency ASTM F2299: ≥98%
Bacterial Filtration Efficiency ASTM F2101: ≥98%
Differential Pressure EN 14683:
§ 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 and 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.
March 19, 2021
Qinghai Zhong Dao Win-win Medical Protective Equipment Co., % 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: K202628
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: February 5, 2021 Received: February 16, 2021
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.
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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 (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,
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
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Indications for Use
510(k) Number (if known) K202628
Device Name Disposable Medical Face Mask
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. This is a single use, disposable device(s), provided nonsterile.
| 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: K202628
I Submitter
Qinghai Zhong Dao Win-win Medical Protective Equipment Co., Ltd. No.36 Jingsan Road, Biological Park, Xining City 810000, Qinghai Province, China Establishment Registration Number: 3016998435 Contact person: Zhaochu Chen Position: QC Manager Tel.: +86-13381230018 Fax: ++086-010-67083032 E-mail: chenzhaochu@jingzhuzangyao.com
Preparation date: March 17, 2021
II Proposed Device
| Trade Name of Device: | Disposable Medical Face Mask |
|---|---|
| Regulation Name: | Surgical Apparel |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
III Predicate Devices
| 510(k) Number: | K173062 |
|---|---|
| Trade name: | Non Woven Face Mask (Models: VQN0185W (earloop) and VQN0185B (ties) |
| Regulation Name: | Surgical Apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | V&Q Manufacturing Corporation |
IV Device description
The Disposable 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 Disposable Medical Face Masks are manufactured with three layers. The outer layer is made of spun-bonded polypropylene (PP) non-woven fabric with blue color. The middle layer with filtration function is made of melt blown
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polypropylene (PP) non-woven fabric. The inner layer contact with face is made of spun-bonded polypropylene (PP) non-woven fabric with white color.
The Disposable Medical Face Masks are single use, disposable device, provided non-sterile.
V Indication 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. This is a single use, disposable device(s), provided non-sterile.
| Item | | Proposed device
(K202628) | Predicate device
(K173062) | Remark |
|-------------------------------------------------------|------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | | Disposable Medical Face Mask | Non Woven Face Mask
(Models: VQN0185W
(earloop) and VQN0185B
(ties) | / |
| 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, 3
Layers | Same |
| Indication 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. This is a single
use, disposable device(s),
provided non-sterile. | Non Woven Face Mask
(Models: VQN0185W
(earloop) and VQN0185B
(ties) is intended for
single use by operating
room personnel and other
general healthcare
workers to protect
both patients and
healthcare workers
against transfer of
microorganisms, blood
and body fluids, and
particulate material. | Same |
| Material | Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | layer | | | |
| | Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Ear loop | Polyamide fiber+
Polyurethane | Urethane elastic fiber or
spun-bond polypropylene | Different1 |
| | Nose piece | Iron wire covered by
polyethylene | White aluminum strip
covered by PP covering | Different1 |
| Color | | Blue | Blue | Same |
| Length | | 17.5cm | 17.5cm | Same |
| Width | | 9.5cm | 9.5cm | Same |
| OTC use | | Yes | Yes | Same |
| sterile | | Non-sterile | Non-sterile | Same |
| Single for use | | Yes | Non-sterile | Same |
| Latex | | Not made with natural
rubber latex | Not made with natural
rubber latex | Same |
| Fluid Resistance
Performance
ASTM F1862 | | Pass at 120mmHg | pass at 120mmHg | Similar 2 |
| Particulate
Filtration
Efficiency
ASTM F2299 | | ≥98% | Average 99.74% at 0.1µm | |
| Bacterial Filtration
Efficiency
ASTM F2101 | | ≥98% | Average 99.4% | |
| Differential
Pressure
EN 14683 | |