(100 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No.
A surgical mask is intended to protect from the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. It is not designed to treat or cure a medical condition.
No
The device is a surgical mask intended for protection and infection control, not for diagnosis. Its performance studies focus on filtration efficiency and material properties, not on detecting or identifying medical conditions.
No
The device description clearly outlines a physical product made of materials like polypropylene, polyester, and spandex, intended to be worn. There is no mention of software components or functionality.
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, and for reducing exposure to blood and body fluids. This is a barrier function, not a diagnostic function.
- Device Description: The description details the physical construction and materials of a surgical mask, which is a physical barrier device.
- Performance Studies and Key Metrics: The performance studies and metrics (BFE, PFE, pressure, blood penetration, flammability, biocompatibility) are all related to the physical barrier and safety properties of the mask, not to the detection or measurement of substances in vitro.
- No mention of IVD activities: There is no mention of analyzing samples (blood, urine, tissue, etc.) or using reagents, which are characteristic of IVD devices.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "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, provided non-sterile.
Product codes
FXX
Device Description
The "SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The "SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices. This product contains no components made with natural rubber latex.
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 test results demonstrate the device's conformance to ASTM F2100-19 for medical face masks, including Bacterial Filtration Efficiency (BFE) >=98%, Particulate Filtration Efficiency (PFE) >=98%, Differential Pressure =98% (Results: 32pass/32tested Accepted)
PFE: >=98% (Results: 32pass/32tested Accepted)
Differential Pressure:
§ 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.
May 7, 2021
Qingdao Hainuo Biological Engineering Co., Ltd. Raphael Wang Director Industrial Park, Jiangshan Town, Laixi City Qingdao, Shandong 266000 China
Re: K210218
Trade/Device Name: SURGICAL MASK, Model Name:C015 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 26, 2021 Received: April 5, 2021
Dear Raphael Wang:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 mediation-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, Ph.D. 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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K210218
Device Name SURGICAL MASK, Model Name:C015
Indications for Use (Describe)
The "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "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, provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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K210218 510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: 29 April 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Qingdao Hainuo Biological Engineering Co., Ltd |
|---|---|
| Address: | Industrial Park, Jiangshan Town, Laixi City |
| Qingdao, Shandong, 266000 China | |
| Contact person: | Raphael Wang |
| Title: | Director |
| E-mail: | hynaut@outlook.com |
| Tel: | +86-15065420708 |
2. Device Identification
| Trade/Device Name: | SURGICAL MASK, Model Name: C015 |
|---|---|
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K200923 |
|---|---|
| Device Name: | Single-use Surgical Mask |
| Manufacturer: | BYD Precision Manufacturer Co.Ltd. |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class II |
| Panel: | General Hospital |
| Product Code: | FXX |
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4. Device Description
The "SURGICAL MASK" is single use, blue color, without face shield, Flat Pleated type, utilizing elastic ear loops for wearing, and it has a Nose Piece design for fitting the facemask around the nose. The "SURGICAL MASK" is manufactured with three layers. The inner and outer layers are made of Non-woven fabric (Polypropylene), and the middle filter layer is made of a melt blown fabric (Polypropylene). The subject device is held in place over the user's mouth and nose by two ear loops welded to the facemask. The elastic ear loop is made of Polyester and Spandex. The nose piece contained in masks is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of iron strip and polypropylene. The "SURGICAL MASK" is sold non-sterile and are intended to be single-use, disposable devices.
This product contains no components made with natural rubber latex.
5. Indication for use
The "SURGICAL MASK" is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorganisms, body fluids and particulate material. The "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.
5
6. Technological Characteristics Comparison
Comparison to the predicate devices, the subject device has same intended use, similar product design, same performance effectiveness, performance safety as the predicate device as summarized in the following table
| SE
Comparisons | Proposed Devices | Predicate Device
K200923 | Similarities/
Differences |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| Name | Surgical Mask | Single-use Surgical Mask | / |
| Model | C015 | FE2311 | / |
| Classification | Class II | Class II | Same |
| Intended use | The Surgical Mask is
intended to be worn to
protect both the patient and
healthcare personnel from
the transfer of
microorganisms, body fluids
and particulate material. The
face 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 Single-use Surgical
Mask (Model:FE2311) is
intended to be worn to
protect both the patient and
health care 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. | Same |
| ASTM F2100
Level | Level 3 | Level 3 | Same |
| Mask Styles | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | Same |
| Color | Blue | Blue | Same |
| Target
population | Adults | Adults | Same |
| Dimension
(length) | $175 \pm 5$ mm | $175 \pm 4$ mm | Similar |
| Dimension
(width) | $95 \pm 5$ mm | $95 \pm 4$ mm | Similar |
| Sterile | Non-sterile | Non-sterile | 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 | OTC | OTC | Same |
| use | | | |
| Material of
Outer layer | Non-woven fabric
(Polypropylene) | Spun-bond polypropylene | Same |
| Material of
middle layer | Melt blown fabric
(Polypropylene) | Melt blown polypropylene
filter | Same |
| Material of
inner layer | Non-woven fabric
(Polypropylene) | Spun-bond polypropylene | Same |
| Material of
ear loops | Polyester and Spandex | Polyester | Similar |
| Material of
Nose piece | Iron strip and Polypropylene | Metal Core Plastic | Same |
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8. Performance Data
Clinical test:
Clinical testing is not required.
Non-clinical data
The proposed device SURGICAL MASK:
Performance:
ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face 1. Masks was conducted on 3 discontinuous lots.
2 . Bacterial Filtration Efficiency-Determine the bacterial filtration efficiency as directed in Test method F2101.
- Differential Pressure -Determine breathing resistance or differential pressure as directed in
EN 14683:2019,Annex C.
-
Sub-Micron Particulate Filtration-Determine particulate filtration efficiency as directed in Test Method F2299
-
Resistance to Penetration by Synthetic Blood-Determine synthetic bloodpenetration resistance as specified in Test Method F1862.
-
Flammability-Determine flammability as specified in 16 CFR Part 1610.
7
Biocompatibility:
-
- ISO 10993-5:2009 Biological evaluation of medical devices Part 5: Tests for in vitro
-
- ISO 10993-10:2010 Biological evaluation of medical devices Part 10: Tests for irritation
and skin sensitization.
| Stand
| ard | Test item | Test method | Criteria | Results |
|---|---|---|---|---|
| ASTM | ||||
| F2100 | ||||
| -19 | BFE | ASTM F2101-19 | ≥98% | 32pass/ |
| 32tested | ||||
| Accepted | ||||
| PFE | ASTM F2299-03(2017) | ≥98% | 32pass/ | |
| 32tested | ||||
| Accepted | ||||
| Differential | ||||
| Pressure | EN | |||
| 14683 :2019+AC (2019)(E), | ||||
| Annex C | 90% humidity for 24 | |||
| hours. After the culture, the | The 50% extract of the test | |||
| article should have at least | ||||
| the same or a higher viability | ||||
| than the 100% extract. | ||||
| Otherwise the test should be | ||||
| repeated. | ||||
| The lower the Viab. % value, | ||||
| the higher the cytotoxic | ||||
| potential of the test article is. | ||||
| If viability is reduced to |