(181 days)
Not Found
No
The device description and intended use clearly describe a standard medical face mask with no mention of AI or ML technology. The "Mentions AI, DNN, or ML" section also explicitly states "Not Found".
No
The device is a medical face mask, intended to protect from transfer of microorganisms and fluids, which is a preventive measure, not a therapeutic treatment for a disease or condition.
No
A diagnostic device is used for diagnosing a condition, disease, or medical problem. The provided text describes a medical face mask, which is a protective barrier device intended to prevent the transfer of microorganisms and particulate matter, not to diagnose any condition.
No
The device description clearly outlines the physical components of a medical face mask (spun-bonded polypropylene, melt blown polypropylene, ear loops, nose piece) and describes it as a single-use, disposable device. There is no mention of software as a component or the primary function of the device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the Medical Face Masks are intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. They act as a physical barrier.
- Lack of Specimen Analysis: The device does not involve the collection or analysis of any biological specimens from a patient.
- Intended Use: The intended use is for infection control practices by healthcare personnel, not for diagnosing or monitoring a patient's health through laboratory analysis.
The information provided describes a personal protective equipment (PPE) device, specifically a medical face mask, which is a physical barrier and not an IVD.
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 polypropylene (PP) fabric. The face mask is provided white color.
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 tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to 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 . Medical Face Masks.
- ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face ● Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019, Medical Face Mask-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 medical face masks to penetration by particulates using latex spheres:
- 16 CFR 1610, Standard for the Flammability of clothing textiles; .
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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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Image /page/0/Picture/0 description: The image shows 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.
December 14, 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: K201629
Trade/Device Name: Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 4, 2020 Received: December 9, 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 (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
2
Indications for Use
510(k) Number (if known) K201629
Device Name Medical Face Mask
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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3
510(k) summary: K201629
l Submitter
Shandong Shengquan New Material Co., Ltd. Diaozhen Industrial Development Zone, Zhangqiu 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: Dec. 03, 2020
II Proposed Device
| Trade Name of Device: | Medical Face Mask |
|---|---|
| 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
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
4
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 polypropylene (PP) fabric. The face mask is provided white color.
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.
| Item | Proposed device | Predicate device
(K153496) | Discuss | |
|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|------------|
| Product name | Medial Face Mask | Disposable Surgical Face
Mask | - | |
| 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 | Same | |
| 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 | 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 particulate
material. These face
masks are intended for
use in infection control | Same | |
| | | potential
exposure to
blood and body fluids.
This is a single use,
disposable device(s),
provided non-sterile. | potential
exposure to
blood and body fluids.
This is a single use,
disposable device(s),
provided non-sterile. | |
| Material | Inner
layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Middl
e
layer | Melt blown polypropylene
filter | Melt blown polypropylene
filter | Same |
| | Outer
layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Ear
loop | Spandex + Polyester | Polyester | Similar1 |
| | Nose
piece | Malleable polyethylene | Malleable aluminum wire | Different1 |
| Color | | White | Blue | Different1 |
| Length | | 17.5±0.88cm | 17.5±1cm | Same |
| Width | | 9.5±0.48cm | 9.5±1cm | Same |
| OTC use | | Yes | Yes | Same |
| Sterile | | Non-sterile | Non-sterile | Same |
| For single use | | Yes | Yes | Same |
| ASTM
Level | F2100 | Level 2 | Level 2 | Same |
VI Comparison of technological characteristics with the predicate devices
5
1 The difference in the materials and colors 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 Non-Clinical Testing
6
Non clinical tests were conducted to verify that the proposed device met all design specifications and is Substantially Equivalent (SE) to 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 . Medical Face Masks.
- ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face ● Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity)
- EN 14683:2019, Medical Face Mask-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 medical face masks to penetration by particulates using latex spheres:
- 16 CFR 1610, Standard for the Flammability of clothing textiles; .
VIII Clinical Testing
No clinical study is included in this submission.
IX Conclusion
The proposed device has the same indication for use and has similar design features and technological characteristic as the predicate device. Performance testing data demonstrates that the proposed device is as safe and as effective as the predicate device. Accordingly, the proposed device is substantially equivalent to the predicate device.