(90 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
The device is a surgical face mask designed to protect against the transfer of microorganisms, body fluids, and particulate material, primarily for infection control. It is not intended for treating or diagnosing a medical condition.
No
Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is used for infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, ear loops, nose piece) and performance testing related to material properties and physical barriers, indicating it is a hardware device.
No, 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 by being worn on the face. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose clip). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are not studies related to the accuracy or reliability of a diagnostic test.
- Lack of IVD Characteristics: An IVD device typically involves testing biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases. This face mask does none of those things.
This device is a medical device, specifically a surgical face mask, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The Surgical Face Mask (non-sterile) is 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 a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
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 as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- 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, Standard Specification for Performance of Materials Used in Medical Face Masks
- ASTM F1862, 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. Medical Face Masks-Requirements and Test Methods;
- ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus;
- ASTM F2299, Standard 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 results from performance testing:
- Fluid Resistance Performance ASTM F1862: 32 out of 32 pass at 120 mmHg (Acceptance Criteria: 29 out of 32 pass at 120 mmHg) - PASS
- Particulate Filtration Efficiency ASTM F2299: 99.16% (Acceptance Criteria: >= 98%) - PASS
- Bacterial Filtration Efficiency ASTM F2101: 99.74% (Acceptance Criteria: >= 98%) - PASS
- Differential Pressure (Delta P) EN 14683 Annex C: 3.7 mmH2O/cm squared (Acceptance Criteria:
§ 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.
0
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February 18, 2021
Nantong Taiweishi Medical Technology Co., Ltd. % Mandy Wu Consultant Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shangghai, Shanghai 200122 China
Re: K203426
Trade/Device Name: Surgical Face Mask (non-sterile) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: November 20, 2020 Received: November 20, 2020
Dear Mandy Wu:
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 Ryan Ortega, PhD 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
2
Indications for Use
510(k) Number (if known) K203426
Device Name Surgical Face Mask (non-sterile)
Indications for Use (Describe)
The Surgical Face Mask (non-sterile) is 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 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) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
for K203426
4
Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China ,226400
510(K) Summary
K203426
Summary prepared date: 2021-02-18
A. Applicant:
Name: Nantong Taiweishi Medical Technology Co., Ltd. Address: Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China ,226400 Contact Person: ZhangXuewen
Tel: +8618761789767
Submission Correspondent: Primary contact: Ms. Mandy Wu Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: min.wu@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Face Mask (non-sterile ) Common Name: Surgical Face Mask Model(s): NA
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K182514 Surgical Face Mask
D. Indications use of the device:
The Surgical Face Mask (non-sterile) is 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.
5
Nantong Taiweishi Medical Technology Co., Ltd. Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China ,226400
This a single use, disposable device(s), provided non-sterile.
E. Device Description:
The proposed device(s) are blue color, and flat pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of nylon and spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device
| Device | Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | Nantong Taiweishi Medical | |||
| Technology Co., Ltd. | Xiantao Zhibo Non-woven | |||
| Products Co., Ltd | - | |||
| 510K number | K203426 | K182514 | - | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| Indications for use | The Surgical Face Mask | |||
| (non-sterile) is 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 a single use, | ||||
| disposable device(s), provided | ||||
| non-sterile. | 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 practices to reduce | ||||
| the potential exposure to blood and | ||||
| body fluids. This is a single use, | ||||
| disposable device(s), provided | ||||
| non-sterile. | Same | |||
| Material | Outer layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clip | Polyethylene | Malleable aluminum wire | Different | |
| Ear loops | Nylon and Spandex | Polyester | Different | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | $175mm+/-5%$ | $17.5cm+/-1cm$ | Similar | |
| Dimension (Width) | $95mm+/-5%$ | $9.5cm+/-1cm$ | Similar |
Table 1 General Comparison
6
Nantong Taiweishi Medical Technology Co., Ltd.
Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province, China 226400
| China ,226400 | |||
|---|---|---|---|
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100 level | Level 2 | Level 2 | Same |
| Biocompatibility | ISO10993 | ISO10993 | Same |
| Fluid | |||
| Resistance | |||
| Performance ASTM | |||
| F1862 | 32 out of 32 passes at 120 mmHg | 32 out of 32 passes at 120 mmHg | Similar |
| Particulate | |||
| Filtration Efficiency | |||
| ASTM F2299 | 99.16% | 99.88% | Similar |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM | |||
| F2101 | 99.74% | 99.6% | Similar |
| Differential | |||
| Pressure (Delta P) | |||
| EN 14683 Annex C | 3.7mm H2O/cm² | 3.0mm H2O/cm² | Similar |
| Flammability 16 | |||
| CFR 1610 | Class 1 | Class 1 | Similar |
From the comparison we found the material of the current nose clip and the ear loop were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
For the performance testing, the test results are not identical to each other, but they are similar and they both meet the requirement of Level 2 medical mask according to the ASTM F 2100.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests for in Vitro cytotoxicity
- A ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests for irritation and skin sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face Masks
- A ASTM F1862, 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. Medical Face Masks-Requirements and Test Methods;
7
Nantong Taiweishi Medical Technology Co., Ltd.
Taihangshan Road, New District, Economic Development Zone, Rudong County, Nantong City, Jiangsu Province,
China ,226400
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus Aureus;
-
ASTM F2299, Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres;
- A 16 CFR 1610, Standard for the Flammability of Clothing Textiles;
| Item | Proposed device | Predicate Device | Acceptance
Criteria (level 2) | Result |
|--------------------------------------------------------|----------------------------------|----------------------------------|----------------------------------|--------|
| Fluid Resistance
Performance ASTM
F1862 | 32 out of 32 pass at
120 mmHg | 32 out of 32 pass at
120 mmHg | 29 out of 32 pass
at 120 mmHg | PASS |
| Particulate Filtration
Efficiency ASTM
F2299 | 99.16% | 99.88% | ≥ 98% | PASS |
| Bacterial Filtration
Efficiency ASTM
F2101 | 99.74% | 99.6% | ≥ 98% | PASS |
| Differential Pressure
(Delta P) EN 14683
Annex C | 3.7 mmH2O/cm² | 3.0 mmH2O/cm² |