(258 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
The device is a surgical mask intended for infection control to protect against the transfer of microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
Explanation: A diagnostic device is used to detect, identify, or monitor health conditions. This device is a surgical mask, which is intended to protect against the transfer of microorganisms, body fluids, and particulate material, functioning as a barrier rather than a diagnostic tool.
No
The device description clearly outlines physical components made of materials like polypropylene, nylon, spandex, and synthetic iron wire, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to protect the wearer and the patient from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on a sample from the human body.
- Device Description: The description details the physical construction and materials of a surgical mask. There are no components or mechanisms described that would be used to analyze a biological sample.
- Performance Studies: The performance studies focus on the physical properties of the mask (filtration efficiency, breathability, fluid resistance, flammability) and biocompatibility. These are relevant to the mask's function as a barrier, not as a diagnostic tool.
- Key Metrics: The key metrics (BFE, PFE, Differential Pressure, Synthetic Blood Penetration Resistance, Flammability) are all related to the physical performance of the mask as a barrier. They are not diagnostic metrics like sensitivity, specificity, or AUC.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This surgical mask does not perform any such function.
N/A
Intended Use / Indications for Use
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the 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, provided nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown 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 ear loop is made of Knited nylon and spandex. The nose clip 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 Synthetic iron wire, PP and PE. The "Disposable Medical 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)
Clinical test:
Clinical testing is not required.
Non-clinical data:
The proposed device Disposable Medical Surgical Mask conducted below testing:
Performance: (Testing was performed using 3 nonconsecutive lots of 32 samples per lot)
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- 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.
Biocompatibility:
- 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.
- ISO 10993-11:2017 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity.
Key Results:
- BFE (ASTM F2101-19): >=98% (Accepted)
- PFE (ASTM F2299-03(2017)): >=98% (Accepted)
- Differential Pressure (EN 14683:2019+AC (2019)(E), Annex C): =98%
- PFE: >=98%
- 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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October 24, 2021
Weihai Dishang Medical Technology Co., Ltd Ricky Xia Manager Room 406-409, Block C, No.213 Torch Road, Torch High-Tech Industrial Development Zone Weihai, Shandong 264209 China
Re: K210348
Trade/Device Name: Disposable Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 25, 2021 Received: September 3, 2021
Dear Ricky Xia:
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 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
2
Indications for Use
510(k) Number (if known) K210348
Device Name Disposable Medical Surgical Mask
Indications for Use (Describe)
The "Disposable Medical Surgical Mask" is intended to be worn to protect both the patient on the 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, provided nonsterile.
| 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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510(K) Summary
Prepared in accordance with the requirements of 21 CFR Part 807.92
Prepared Date: August 25, 2021
1. Submitter's Information
The submitter of this pre-market notification is:
| Name: | Weihai Dishang Medical Technology Co.,Ltd |
|---|---|
| Address: | Room 406-409,Block C,No.213 Torch Road,Torch High-tech |
| Industrial Development Zone,Weihai,Shandong China | |
| Contact person: | Ricky.xia |
| Title: | Manager |
| E-mail: | ricky.xia@dishang.com |
| Tel: | +86- 18663126766 |
2. Device Identification
| 510(K) number: | K210348 |
|---|---|
| Trade/Device Name: | Disposable Medical Surgical Mask |
| Models: | DSAL2-WHITE, DSAL1-WHITE |
| Common name: | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
3. Predicate Device
| 510(K) number: | K202463 |
|---|---|
| Device Name: | Disposable Surgical Mask |
| Manufacturer: | UNISOURCES GROUP LLC |
| Common name | Mask, Surgical |
| Regulation Number: | 878.4040 |
| Regulation Name: | Surgical apparel |
| Regulation Class: | Class 2 |
| Panel: | General Hospital |
| Product Code: | FXX |
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4. Device Description
The "Disposable Medical Surgical Mask" is single use, without face shield, Flat Pleated type, utilizing ear loops for wearing, and it has a Nose clip design for fitting the facemask around the nose. The "Disposable Medical Surgical Mask" is manufactured with three layers. The inner and outer layers are made of Spunbond fabric (Polypropylene), and the middle filter layer is made of a meltblown 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 ear loop is made of Knited nylon and spandex. The nose clip 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 Synthetic iron wire, PP and PE. The "Disposable Medical 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 " Disposable Medical Surgical Mask " is intended to be worn to protect both the patient and healthcare personnel from the transfer of microorqanisms, 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.
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6. Technological Characteristic Comparison to Predicate Device
Comparison to the predicate devices summarized in the following table
| SE
Comparisons | Proposed Device
DSAL2-WHITE
K210348 | Proposed Device
DSAL1-WHITE
K210348 | Predicate Device
K202463 | Comparison |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Name | Disposable Medical Surgical
Mask | Disposable Medical Surgical
Mask | Disposable Surgical Mask | / |
| Model | DSAL2-WHITE | DSAL1-WHITE | FILTECH M201 | / |
| Classification | Class 2 | Class 2 | Class 2 | Same |
| Intended use | The "Disposable Medical
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 "Disposable Medical
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 Disposable Surgical
Mask, FILTECH M201 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 2 | Level 1 | Level 2 | Different
Note 1 |
| Mask Styles | Flat Pleated | Flat Pleated | Flat Pleated | Same |
| Design features | Ear loop | Ear loop | Ear loop | Same |
| Layers | 3 | 3 | 3 | Same |
| Color | White | White | Blue outside; white inside | Similar
Note 2 |
| Target
population | Adults | Adults | Adults | Same |
| Dimension
(length) | $175 mm\pm 5 mm$ | $175 mm\pm 5 mm$ | $175 \pm 5 mm$ | Same |
| Dimension
(width) | $95 mm\pm 5 mm$ | $95 mm\pm 5 mm$ | $95 \pm 5 mm$ | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Use | Single use, disposable | Single use, disposable | Single use, disposable | Same |
| Anatomical site | Nose and mouth | Nose and mouth | Nose and mouth | Same |
| Technology | Self-suction filter mask | Self-suction filter mask | Self-suction filter mask | Same |
| Environment of
use | OTC | OTC | OTC | Same |
| Material of
Outer layer | Spunbond fabric
(Polypropylene) | Spunbond fabric
(Polypropylene) | Spunbond polypropylene | Same |
| Material of
middle layer | Meltblown fabric
(Polypropylene) | Meltblown fabric (Polypropylene) | Melt blown polypropylene
filter | Same |
| Material of
inner layer | Spunbond fabric
(Polypropylene) | Spunbond fabric
(Polypropylene) | Spunbond polypropylene | Same |
| Material of
ear loops | Knitted nylon and spandex | Knitted nylon and spandex | Spandex | Similar
Note 3 |
| Material of
Nose clip | Synthetic iron wire,PP and PE | Synthetic iron wire,PP and PE | Malleable polyethylene wire | Similar
Note 3 |
| Colorants | / | / | Polypropylene (PP) master
batch | Similar
Note 2 |
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| Performance | |||||
|---|---|---|---|---|---|
| Test item | Test standard | Proposed Device | |||
| DSAL2-WHITE | |||||
| K210348 | Proposed | ||||
| Device | |||||
| DSAL1-WHITE | |||||
| K210348 | Predicate | ||||
| Device | |||||
| K202463 | Remark |
7
| BFE | ASTM F2101-19 | ≥98% | ≥98% | ≥98% | Same |
|---|---|---|---|---|---|
| PFE | ASTM F2299-03(2017) | ≥98% | ≥98% | ≥98% | Same |
| Differential Pressure | EN | ||||
| 14683 :2019+AC (2019)(E) | |||||
| Annex C | 90% humidity for 24 | ||||
| hours. After the culture the | |||||
| morphology and cell lysis of | |||||
| the cells were observed | |||||
| under the microscope, and | |||||
| the cytotoxicity of the test | 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 |