(136 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask. There is no mention of AI or ML in the text.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and fluids, reducing potential exposure. It does not treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
The device description indicates it is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, multi-layered face mask made of nonwoven and melt blown fabrics with ear straps and a nose piece. The performance studies focus on physical properties like filtration efficiency, pressure resistance, and flammability, which are characteristic of hardware devices, not software. There is no mention of software components, algorithms, or data processing.
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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. 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, ear straps, nose piece). There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical and barrier properties of the mask (filtration efficiency, pressure resistance, blood penetration, flammability, biocompatibility). These are not diagnostic performance metrics like sensitivity, specificity, or accuracy in detecting a disease or condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information for the diagnosis, monitoring, or treatment of a disease or condition based on in vitro testing.
In summary, this device is a physical barrier intended for infection control, not a diagnostic tool.
N/A
Intended Use / Indications for Use
Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
Product codes
FXX
Device Description
The Surgical face mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of HDPE (high density polyethylene). The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
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
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
Non-Clinical Test Conclusion: The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Key results:
Bacterial filtration efficiency (BFE) (%): 98.999.7% Pass (Acceptance Criteria: ≥98)5.0 mmH2O/cm² Pass (Acceptance Criteria:
Different pressure (mmH2O/cm²): 4.1
§ 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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September 11, 2021
Sunsmed Protective Products Ltd. % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K211296
Trade/Device Name: Surgical face mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 5, 2021 Received: August 10, 2021
Dear Boyle 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
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,
Clarence W. Murray III -S
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K211296
Device Name Surgical face mask
Indications for Use (Describe)
Surgical face mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
| 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 — K211296
This 510(k) summary is being submitted in accordance with 21 CFR 807.92.
1.0 Submitter's information
Name: Sunsmed Protective Products Ltd. Address: No.18, Industrial park, Maozui Town, Xinatao City, 433000, Hubei Province, China Phone Number: +86-15271236397 Contact: Ms. Joyce Lee Date of Preparation: 16/03/2021
Designated Submission Correspondent
Mr. Boyle Wanq Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device information
Trade name: Surgical face mask Common name: Surgical face mask Classification name: Mask, Surgical Model(s): ear strap, 175×95mm
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Surgical apparel Panel:
4.0 Predicate device information
Manufacturer: Wuhan Dymex Healthcare Co., Ltd Device: Surgical Face Mask 510(k) number: K182515
5.0 Indication for Use Statement
Surgical face mask is intended to be worn to protect both the patient and healthcare
4
personnel from transfer of microorganisms, body fluids and particulate material. It 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.
6.0 Device description
The Surgical face mask is single use, three-layer, flat-pleated style with ear straps and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear straps are held in place over the users' mouth and nose by two elastic ear straps welded to the facemask. The elastic ear straps are not made with natural rubber latex. The nose piece on the layers of facemask is to allow the user to fit the facemask around their nose, which is made of HDPE (high density polyethylene). The Surgical face mask will be provided in blue. The masks are sold non-sterile and are intended to be single use, disposable devices.
| Table 1 - General Comparison | ||||
|---|---|---|---|---|
| Item | Proposed device | Predicated device | Comparison | |
| Product Code | FXX | FXX | Same | |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Class | II | II | Same | |
| Product name | Surgical face mask | Surgical Face Mask | - | |
| 510(k) No. | K211296 | K182515 | - | |
| Models | ear strap, 175×95mm | ear strap | - | |
| Intended Use | The Surgical face mask is | |||
| intended to be worn to | ||||
| protect both the patient and | ||||
| healthcare personnel from | ||||
| transfer of microorganisms, | ||||
| body fluids and particulate | ||||
| material. It 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 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 | |||
| OTC use | Yes | Yes | Same | |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Similar | |
| Material | Internal | |||
| layer | Spun-bond | |||
| polypropylene | Spun-bond polypropylene | Similar | ||
| Middle | ||||
| layer | Melt blown | |||
| polypropylene | Melt blown polypropylene | Similar | ||
| External | Spun-bond | Spun-bond polypropylene | Similar |
7.0 Technological Characteristic Comparison Table
5
| layer | polypropylene | |||
|---|---|---|---|---|
| Nose | ||||
| piece | High Density | |||
| Polyethylene | Malleable polyethylene | |||
| wire | * Gap 1 | |||
| ear strap | Polyester, spandex | spandex | * Gap 2 | |
| Color | Blue | Yellow | * Gap 3 | |
| Dimension (Length) | $17.5cm\pm0.5cm$ | $17.5cm\pm0.2cm$ | * Gap 4 | |
| Dimension | ||||
| (Width) | $9.5cm\pm0.5cm$ | $9.5cm\pm0.2cm$ | * Gap 5 |
| Dimension
| (Width) | |||
|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Same |
| Single Use | Yes | Yes | Same |
| Sterile | No | No | Same |
| ASTM F2100 | |||
| Level | Level 2 | Level 2 | Same |
- Gap analysis:
Gap 1-3: the two devices have some difference in materials and product color. Gap 4-5: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance..
8.0_Clinical Test Conclusion
No clinical study implemented for the Surgical face mask.
9.0Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
| Table 2 - Performance Testing | |
|---|---|
| ------------------------------- | -- |
| Items | Purpose | Acceptance Criteria
(Level 2, ASTM
F2100-19) | Result |
|----------------------------------------------|-----------------------------------------------------------------------------------------------------|----------------------------------------------------|---------------------------|
| Bacterial filtration
efficiency (BFE) (%) | The purpose of
the test is to
evaluate the
Bacterial filtration
efficiency (BFE)
(%) | ≥98 | 98.9~99.7%
Pass |
| Different pressure
(mmH2O/cm²) | The purpose of
the test is to
evaluate the
Different pressure
(mmH2O/cm²) |