(149 days)
Not Found
No
The 510(k) summary describes a standard surgical mask and its physical properties and performance against filtration and fluid resistance standards. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No.
A therapeutic device is used to treat or cure a disease or condition. This device is a surgical mask intended to prevent the transfer of microorganisms and reduce exposure, which is a preventive measure rather than a therapeutic one.
No.
The provided text explicitly states the mask is intended to protect healthcare personnel and patients from the transfer of microorganisms and fluids, indicating a barrier function, not a diagnostic one.
No
The device description clearly outlines a physical product made of multiple layers of non-woven fabric, designed to be worn on the face. It is a tangible, disposable hardware device.
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 individuals from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details the physical construction of the mask and its materials. There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, filtration efficiency, differential pressure, flammability). These are not diagnostic performance metrics.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
In summary, this device is a medical surgical mask designed for personal protection, not for performing diagnostic tests.
N/A
Intended Use / Indications for Use
The Medical surgical mask 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 is a single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
The Medical surgical mask is Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose.
The Medical surgical mask is manufactured with three layers. The outer layer is made of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color.
The Medical surgical mask is single use, disposable device, 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
Not Found
Intended User / Care Setting
Healthcare personnel / 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 Testing:
Methodology: ASTM F1862M-17, ASTM F2299, ASTM F2101-19, EN 14683:2019 Annex C, 16 CFR 1610.
Purpose: Fluid Resistance Performance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability.
Acceptance Criteria: 29 out of 32 pass at 160mmHg (ASTM F1862M-17), >=98% (ASTM F2299), >=98% (ASTM F2101-19),
§ 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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July 8. 2021
Shantou T&K Medical Equipment Factory Co.,Ltd % Stuart Situ Director Landlink Healthcare Technology (Shanghai) Co., Ltd. Room 1308, Baohua International Plaza, West Guangzhong Road 555 Shanghai, 200071 China
Re: K210380
Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 26, 2021 Received: May 28, 2021
Dear Stuart Situ:
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.
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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.
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) K210380
Device Name Medical surgical mask
Indications for Use (Describe)
The Medical surgical mask 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 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)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary K210380
I. Submitter
Shantou T&K Medical Equipment Factory Co.,Ltd No.8 Workshop, Wanji South Second Street Shantou, Guangdong CN515065
Establishment Registration Number: 3016710550
Contact person: Wan Li Position: Manager Tel.: +86 15992258456 E-mail: triangel.wan@163.com
Preparation date: July.8, 2021
II. Proposed Device
| Trade Name of Device: | Medical surgical mask |
|---|---|
| Common name: | Surgical Mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | General Hospital |
III. Predicate Devices
| 510(k) Number: | K160269 |
|---|---|
| Trade name: | Surgical Face masks (Ear loops and Tie-on) |
| Common name: | Surgical Mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | San-M Package Co., Ltd. |
IV. Device Description
The Medical surgical mask is Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all have Nose Piece design for fitting the face mask around the nose.
The Medical surgical mask is manufactured with three layers. The outer layer is made
4
of polypropylene (PP) non-woven fabric with blue color. The middle layer is filtration function and is made of polypropylene (PP) melt-blown non-woven fabric. The inner layer contact with face is made of polypropylene (PP) non-woven fabric with white color.
The Medical surgical mask is single use, disposable device, provided non-sterile.
V. Indication for Use
The Medical surgical mask 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 is a single use, disposable device, provided non-sterile.
VI. Comparison of Technological Characteristics with the Predicate Devices
| Item | Proposed Device (K210380) | Predicate Device (K160269) | Comparison |
|---|---|---|---|
| Trade Name | Medical surgical mask | Surgical Face masks (Ear loops and Tie-on) | Different |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | Class II | Class II | Same |
| Mask Style | Flat-pleated, ear loops, 3 layers | Flat-pleated, ear loops or tie-on, 4 layers | Different |
| Indication for Use | The Medical surgical 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 | The Surgical face masks are intended to be worn to protect the patient and healthcare personnel from transfer of microorganisms, blood fluid, and particulate material. These face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluid. This is a single-use, disposable devices provided non-sterile. | Similar |
Table 10-1 General Comparison
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| single use, disposable | |
|---|---|
| device, provided non-sterile. | |
| Material | Inner
layer | | Polypropylene | Different |
|---------------------|-----------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Middle
layer | Polypropylene melt-
blown
non-woven fabric | 1. Polypropylene spun-bond
2. Polypropylene melt blown | Similar |
| | Outer
layer | Polypropylene
nonwoven | Polypropylene | Similar |
| | Ear loops | Ear loops: Spandex
Tie bands:
Polypropylene
nonwoven | Ear loops: Polyester, polyurethane;
Side tapes: Polyester
spun-bond (ear loops mask
only)
Ties tapes: Polypropylene
spun-bond or polyester
spun-bond | Different |
| | Nose
piece | PP、PE, galvanized | Polyethylene coated
steel wire | Different |
| Color | | Blue | Blue ,white | Different |
| Dimension | | 17.5cmx9.5cm | 17.5cmx9.0cm
18.0cmx9.0cm | Similar |
| OTC Use | | Yes | Yes | Same |
| Sterile | | Non-sterile | Non-sterile | Same |
| For single Use | | Yes | Yes | Same |
| ASTM F2100
Level | | Level 3 | Level 1: Pass at 80mmHg
Level 2: Pass at 120mmHg
Level 3: Pass at 160mmHg | Similar |
6
| Biocompatibility | Confirm to the
requirements of
ISO 10993 series
standards | Confirm to the requirements of
ISO 10993 series standards | Same |
| ------------------ | -------------------------------------------------------------------- | -------------------------------------------------------------- | ------ |
|---|
V. Non-Clinical Testing
Non-clinical performance tests were conducted to verify that the proposed device met all design specifications. The below table shows the test results of test article, which demonstrated that the proposed device complies with the standards of ASTM F2100-19:
| Methodology | Purpose | Acceptance Criteria | Results (3 Lots) |
|---|---|---|---|
| ASTM F1862M-17 | Fluid Resistance | ||
| Performance | 29 out of 32 pass at | ||
| 160mmHg | Pass | ||
| ASTM F2299 | Particulate Filtration | ||
| Efficiency | ≥98% | Pass | |
| ASTM F2101-19 | Bacterial Filtration | ||
| Efficiency | ≥98% | Pass | |
| EN 14683:2019 | |||
| Annex C | Differential Pressure |