(259 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.
A therapeutic device is used to treat, cure, or prevent disease. This device is a surgical mask intended to protect against the transfer of body fluids, microorganisms, and particulate material, which is a protective rather than a therapeutic function.
No
The device description and intended use clearly state that it is a surgical mask designed to protect against the transfer of body fluids, microorganisms, and particulate material. It does not mention any diagnostic capabilities.
No
The device description clearly outlines physical components (layers of polypropylene, ear-loops, nose piece) and the performance studies focus on physical properties and biocompatibility, not software functionality.
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. They are used outside of the body.
- Sheng Jing Tang Surgical Mask Function: The intended use and device description clearly state that this is a surgical mask designed to be worn on the face to protect against the transfer of body fluids, microorganisms, and particulate material. It acts as a physical barrier.
- Lack of Diagnostic Function: The device does not analyze any biological samples or provide any diagnostic information about a patient's health status.
The information provided describes a medical device, specifically a surgical mask, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene), Middle Layer filter (Polypropylene Melt-blown Cloth), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, 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
Adult only.
Intended User / Care Setting
healthcare settings
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)
Nonclinical tests were conducted to verify that the proposed device met all design specifications, as was Substantially Equivalent (SE) to the predicate device.
A bench test was conducted on Sheng Jing Tang Surgical Mask for the proposed device to determine substantial equivalence. The bench tests include the following tests:
- Fluid Resistance Performance ASTM F1862-17. Sample size: 96/96 (32 Samples Each from 3 non-consecutive lots). Key results: Passed.
- Particulate Filtration Efficiency ASTM F2299-17. Sample size: 96/96 (32 Samples Each from 3 non-consecutive lots). Key results: Passed.
- Bacterial Filtration Efficiency ASTM F2101-19. Sample size: 96/96 (32 Samples Each from 3 non-consecutive lots). Key results: Passed.
- Differential Pressure (Delta P) EN 14683:2019, Annex C and ASTM F2100-20. Sample size: 96/96 (32 Samples Each from 3 non-consecutive lots). Key results: Passed.
- Flammability 16 CFR 1610. Sample size: 96/96 (32 Samples Each from 3 non-consecutive lots). Key results: Class 1 Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). 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 in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font.
January 10, 2022
Liaoning Shengjingtang Biotechnology Co., Ltd. Hai Luan CEO Huamei (Dalian) Health Industry Co., Ltd RM. 956 NO. 60-2 Haixing St, Dalian Tax-Free Zone Dalian, 116001 China
Re: K211260
Trade/Device Name: Sheng Jing Tang Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 28, 2021 Received: December 1, 2021
Dear Hai Luan:
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,
For Clarence W. Murray, III, Ph.D. 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) K211260
Device Name Sheng Jing Tang Surgical Mask
Indications for Use (Describe)
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided 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
This 510(k) Summary is being submitted in accordance with the requirements of Title 21. CFR Section 807.92.
The assigned 510(k) number: K211260 Date of Preparation: 11/02/2021
1. Contact Information
1.1 Applicant
Applicant Name: Liaoning Shengjingtang Biotechnology Co., Ltd. Address: 123-11 Huishan St, Shenbei New District, Shenyang, Liaoning, China 110141 Contact Person: Li Ke Title: General Manager Telephone: +86-135-914-61018 Email: 174866792@qq.com
1.2 Consultant
Company: Huamei (Dalian) Health Industry Co., Ltd Address: RM. 956 NO.60-2 Haixing St, Dalian Tax-Free Zone, China, 116001 Contact Person: Luan Hai Telephone: +1 503-559-0930 Email: usfdahuamei@hotmail.com
2. Device Information
Trade Name: Sheng Jing Tang Surgical Mask Common Name: Surgical Face Mask Regulatory information: Classification Name: Mask, Surgical Classification: II Product Code: FXX Regulation Number: 21 CFR 878.4040 Review Panel: General Hospital
3. Legally Marketed Primary Predicate Device
Product name: Avianz® Surgical Face Mask 510(k) Number: K200847 Product Code: FXX Manufacture: MEXPO INTERNATIONAL INC.
4. Indication For Use
Sheng Jing Tang Surgical Mask is intended for use in healthcare settings, procedures during which a face mask is necessary to protect both patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material. The device is indicated to be over-the-counter use. Adult only. The device is disposable and is indicated for single use. The device is not provided sterile.
5. Device Description
The Sheng Jing Tang Surgical Masks are composed of 3-layers and are flat-pleated provided blue color, the mask materials consist of an outer layer (Spun-bond polypropylene), Inner layer (Spun-bond polypropylene),
Sheng Jing Tang Surgical Mask
4
Middle Layer filter (Polypropylene Melt-blown Cloth), Ear-loops (Spandex + Nylon, Ear Loops way for wearing) and Nose piece (a Polyethylene + Galvanized Iron wire nosepiece to provide a firm fit over the nose and then to secure the mask over the users' mouth and face). The Sheng Jing Tang Surgical Masks are single use, disposable device, adult only, provided non-sterile.
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Product Code | FXX | FXX | Same |
| Regulation | 21 C.F.R Section 878.4040 | 21 C.F.R Section 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Intended use | Sheng Jing Tang Surgical Mask is
intended for use in healthcare
settings, procedures during which
a face mask is necessary to
protect both patient and
healthcare personnel from transfer
of body fluids, microorganisms,
and particulate material.
The device is indicated to be
over-the-counter use. Adult only.
The device is disposable and is
indicated for single use.
The device is not provided sterile. | The Disposable Surgical
Face Masks are intended to
be worn to protect both the
patient and healthcare
personnel from the 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. | Same |
| Mask Style | Flat-pleated, earloop, 3 layers | Flat-pleated, earloop, 3 layers | Same |
6. Substantially Equivalent (SE) Comparison
6.1 Material Used
| Comparison Items | Sheng Jing Tang Surgical
Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|----------------------------------------|-------------------------------------------------------------|-------------|
| Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene Melt-blown
cloth | Melt blown polypropylene filter | Same |
| Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Earloop | Spandex + Nylon | Polyester | *Different¹ |
| Nose piece | Polyethylene +
Galvanized Iron wire | Malleable aluminum wire | *Different¹ |
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6.2 Design Features
| Comparison Items | Predicate Device | Comparison | ||
|---|---|---|---|---|
| Sheng Jing Tang Surgical Mask Avianz® Surgical Face Mask | ||||
| (K200847) | ||||
| Use Environment | OTC, or Healthcare or related settings | OTC, or Healthcare or related settings | Same | |
| Single-use/ | ||||
| use | Multiple- | Single-use | Single-use | Same |
| Color | Blue | Blue | Same |
6.3 Sterility
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask (K200847) | Comparison |
|------------------|-------------------------------|----------------------------------------------------------|------------|
| Sterilization | No-Sterile | No-Sterile | Same |
6.4 Dimension
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|------------------|-------------------------------|-------------------------------------------------------------|-------------|
| Length | $17.5\pm0.875$ cm | $17.5\pm1$ cm | *Different1 |
| Width | $9.5\pm0.475$ cm | $9.5\pm1$ cm | *Different1 |
6.5 Effectiveness / Performance
| Comparison Items | Sheng Jing Tang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------|
| Resistance to Penetration
by Synthetic blood
ASTM F1862/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) | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: 32 Out of 32 pass at 120 mmHg
Lot 2: 32 Out of 32 pass at 120 mmHg
Lot 3: 32 Out of 32 pass at 120 mmHg | ≥ 30 Out of 32 pass at 120 mmHg | Same |
| Particulate Filtration
Efficiency ASTM
F2299/F2299M-03
(2017) Standard Test
Method for Determining
the Initial Efficiency of | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: ≥ 98.24% | ≥ 99.9% | *Different² |
| Material Used in medical
Face Masks to
Penetration by
Particulates using Latex
Spheres | Lot 2: ≥ 98.78%
Lot 3: ≥ 98.82% | | |
| Bacterial Filtration
Efficiency ASTM
F2101-2019 Standard
Test Method for
Evaluating the Bacterial
Filtration Efficiency
(BFE) of Medical Face
Mask Materials, Using a
Biological Aerosol of
Staphylococcus aureus | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: ≥ 99.9%
Lot 2: ≥ 99.9%
Lot 3: ≥ 99.9% | ≥98% | *Different³ |
| Differential Pressure EN
14683:2019 Medical face
masks- Requirements
and test methods | Pass (96/96) 32 Samples Each
from 3 non-consecutive lots
Lot 1: Average 5.56 mmH20/cm²
Lot 2: Average 5.51 mmH20/cm²
Lot 3: Average 4.97 mmH20/cm²
(EN 14683:2019, Annex C and
ASTM F2100-20) | 3.0 mmH20/cm² (MILM-
36954C) | *Different⁴ |
| Flammability 16 CFR
1610 Standard for the
Flammability of Clothing
Textiles Corrections | Class 1 Pass (96/96) 32 Samples
Each from 3 non-consecutive
lots
Lot 1: Class 1 Pass
Lot 2: Class 1 Pass
Lot 3: Class 1 Pass | Class 1 | Same |
| 6.6 Safety | | | |
| Comparison
Items | Sheng Jing Tang Surgical Mask | Predicate Device
Avianz® Surgical Face Mask
(K200847) | Comparison |
| In Vitro Cytotoxicity
Test
ISO 10993-5: 2009 | ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-
cytotoxic. | ISO 10993-5; Under the
conditions of the study, the
proposed device extract was
determined to be non-
cytotoxic. | Same |
| Skin Irritation Test
ISO 10993-10:2010 | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-irritating. | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-irritating. | Same |
| Skin Sensitization Test
ISO 10993-10:2010 | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing. | ISO 10993-10;
Under the conditions of the
study, the proposed device
extract was determined to be
non-sensitizing. | Same |
| Flammability | Class 1 | Class 1 | Same |
6
7
"Different! The difference in the materials, colors, and sizes do not raise additional questions for the device's safety and effectiveness. The subject devices' biocompatibility evaluation test and performed on the final finished device, including all construction materials, color and sizes. The test results indicated that pass the requirements.
*Different? The test was performed in accordance with ASTM F2299-03 (Reapproved 2017) Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres, to determine the Particle Filtration Efficiency. Here, Sheng Jing Tang Surgical Mask compares to Predicate Device that results are very closed by statistics. Thus, this difference does not substantially affect equivalence between the Sheng Surgical Mask and predicate devices.
*Different The test was performed in accordance with ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Materials, using a Biological Aerosol of Staphylococcus aureus the bacterial filtration efficiency (BFE) of the test article. Here, Sheng Jing Tang Surgical Mask compares to Precisate Device that results are very closed by statistics. Thus, this difference does not substantially affect equivalence between the Sheng Jing Tang Surgical Mask and predicate devices.
Different The test result for different pressure for the proposed device is different from predicate devices. The differential pressure test standard has been updated to EN14683:2019, Annex C in ASTM F2100:2020. The differential pressure test of the proposed device was conducted according to EN14683:2019, Annex C, and the test result demonstrates that the differential pressure of the proposed device meets the requirements of level 2 specified in ASTM F2100:2020. Thus, this difference does not substantially affect equivalence between the Sheng Jing Tang Surgical Mask and predicate devices.
7. Nonclinical Test
Nonclinical tests were conducted to verify that the proposed device met all design specifications, as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:
7.1 Performance Test:
A bench test was conducted on Sheng Jing Tang Surgical Mask for the proposed device to determine
Sheng Jing Tang Surgical Mask 510(k) number: K211260
8
substantial equivalence. The bench tests include the following tests:
| Performance Test | Sheng Jing Tang Surgical Mask | Acceptance Criteria | Result |
|---|---|---|---|
| Fluid Resistance Performance | |||
| ASTM F1862-17 | Pass (96/96) 32 Samples Each | ||
| from 3 non-consecutive lots | $\geq$ 29 of 32 pass at 120 mmHg | Passed | |
| Lot 1: 32 Out of 32 pass at 120 mmHg | |||
| Lot 2: 32 Out of 32 pass at 120 mmHg | |||
| Lot 3: 32 Out of 32 pass at 120 mmHg | |||
| Particulate Filtration | |||
| Efficiency ASTM F2299-17 | Pass (96/96) 32 Samples Each | ||
| from 3 non-consecutive lots | $\geq$ 98% | Passed | |
| Lot 1: $\geq$ 98.24% | |||
| Lot 2: $\geq$ 98.78% | |||
| Lot 3: $\geq$ 98.82% | |||
| Bacterial Filtration Efficiency | |||
| ASTM F2101-19 | Pass (96/96) 32 Samples Each | ||
| from 3 non-consecutive lots | $\geq$ 98% | Passed | |
| Lot 1: $\geq$ 99.9% | |||
| Lot 2: $\geq$ 99.9% | |||
| Lot 3: $\geq$ 99.9% | |||
| Differential Pressure (Delta P) EN | |||
| 14683:2019, Annex C and ASTM | |||
| F2100-20. | Pass (96/96) 32 Samples Each | ||
| from 3 non-consecutive lots |