(56 days)
Not Found
No
The description focuses on the physical materials and construction of a surgical face mask, with no mention of AI, ML, or any computational processing.
No
The device is a surgical face mask intended for protection and infection control, not for treating any specific condition or disease.
No
Explanation: The device is a surgical face mask, an infection control barrier. Its intended use is to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose any condition.
No
The device description clearly outlines physical components (three-layer mask, nose piece, ear loops) and performance testing related to material properties and physical barriers, indicating it is a 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 masks are for protecting against the transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of components designed to detect, measure, or analyze biological samples (like blood, urine, tissue, etc.) for diagnostic purposes.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, flammability, biocompatibility). These are relevant to a medical device used as a physical barrier, not an IVD.
- Lack of IVD-Specific Information: There is no information about sample types, analytical methods, or diagnostic performance metrics (like sensitivity, specificity, etc., in the context of diagnosing a condition).
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not fit that definition.
N/A
Intended Use / Indications for Use
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.
Product codes
FXX
Device Description
The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the face mask is composed of 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.
The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.
The surgical face 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 tests were conducted to verify that the proposed device met all design specification for the standards and test methods. 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
- ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation
- 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, stand 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:
- Fluid Resistance: 32 out of 32 pass at 160 mmHg, 3 lots
- Particulate Filtration Efficiency: minimum 99.21%
- Bacterial Filtration Efficiency: 99.9%
- Differential Pressure: Maximum 3.7mmH2O/cm²
- Flammability: Class 1
- Cytotoxicity: Under the conditions of the study, the device is non-cytotoxic.
- Irritation: Under the conditions of the study, the device is non-irritating.
- Sensitization: Under the conditions of the study, the device is non-sensitizing.
Key Metrics
- Fluid Resistance: 32 out of 32 pass at 160 mmHg
- Particulate Filtration Efficiency: ≥ 98% (Result: minimum 99.21%)
- Bacterial Filtration Efficiency: ≥ 98% (Result: 99.9%)
- 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 2, 2023
Kingstar Medical (Xianning) Co., Ltd. % Ms. Ivy Wang Technical Manager Shanghai Sungo Management Consulting Co. Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai China
Re: K232359
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 7, 2023 Received: August 7, 2023
Dear Ms. 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.
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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.
Brent Showalter -S
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K232359
Device Name Surgical Face Mask
Indications for Use (Describe)
The Surgical Face Masks are intended to be worn to protect both the patient and healthcare persomel 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.
Type of Use (Select one or both, as applicable)
| Transactional Use (Identify STEs which belong to a Single Transaction) |
|---|
| Data Store (Comprehensive Use of STE data for a variety of purposes) |
| | 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 summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Prepared date: 2023-08-04 A. Applicant: Kingstar Medical (Xianning) Co., Ltd. Address: No.79 Yong'andong Road, Xian'an District, Xianning City, Hubei Province, China Contact Person: Mr. Fan Rong Tel: +86 15871408114 Email: fan.rong@kingstarmedical.cn
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: zxfda@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1401, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: Surgical Face Mask Common Name: Surgical Mask Model: Ear loop
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device: (Primarv)
K210433 Surgical Face Mask Wuhan Dymex Healthcare Co., Ltd.
D. Indications for use of the device:
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 intended
4
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.
E. Device Description:
The Surgical Face Mask is blue color, single use, three-layer, flat-folded masks with nose piece and ear loops. The blue colorant is polypropylene (PP) master batch.
The body of the face mask is composed of 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 two elastic ear loops are welded to the face mask, can held the face mask in place over the users' mouth and nose. The elastic ear loops are made of Spandex and polyester, is not made with natural rubber latex.
The nose piece is in the layers of the facemask to allow the user to fit the facemask around their nose, which is made of PP-Ferrum wire.
The surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Device Proposed Device Predicate Device Result 510K number K210433 --Model name Surgical Face Mask Surgical Face Mask Same Class II Device, FXX (21 Class II Device, FXX (21 Same Classification CFR878.4040) CFR878.4040) The Surgical Face Masks are The Surgical Face Masks are Same intended to be worn to protect intended to be worn to protect both the patient and healthcare both the patient and healthcare personnel from transfer of personnel from transfer of microorganisms, body fluids and microorganisms, body fluids particulate material. These face and particulate material. These Intended use masks are intended for use in face masks are intended for use infection control practices to in infection control practices to reduce the potential exposure to reduce the potential exposure blood and body fluids. This is a to blood and body fluids. This single use, disposable device(s), is a single use, disposable provided non-sterile. device(s), provided non-sterile. Ear Loops, Tie-on, Similar Model Ear loop, Flat pleated,3 layers Flat-pleated, 3 layers Outer Same Spun-bond polypropylene Spun-bond polypropylene layer Same Middle Material Melt blown polypropylene Melt-blown Polypropylene layer Inner Same Spun-bond polypropylene Spun-bond polypropylene layer
F. Comparison with predicate device
Table 1 General Comparison
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| Nose piece | PP-Ferrum wire | Malleable polyethylene wire | Different | |
|---|---|---|---|---|
| Ear loops | Spandex, polyester | Spandex | Different | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 17.5cm±0.2cm | 17.5cm±0.2cm | Same | |
| Dimension (Width) | 9.5cm±0.1cm | 9.5cm±0.2cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 level | Level 3 | Level 3 | Same | |
| Fluid | ||||
| F1862 | Resistance | |||
| Performance ASTM | 32 out of 32 pass at 160 mmHg | 32 out of 32 pass at 160 mmHg | Same | |
| Efficiency | ||||
| F2299 | Particulate Filtration | |||
| ASTM | ≥ 98% | ≥ 98% | Same | |
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| F2101 | ASTM | ≥ 98% | ≥ 98% | Same |
| Differential Pressure | ||||
| (Delta P) EN 14683 | ||||
| Annex C | ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Tests for irritation |
- ASTM F2100, Standard Specification for Performance of Materials Used in Medical Face A 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;
6
- 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, stand 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;
| Test Methodology | Purpose | Acceptance Criteria:
ASTM F2100 Level 3 | Result |
|-----------------------------------|---------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------------------------------|
| Fluid Resistance | The purpose of the performance testing is to demonstrate the functionality of the subject device. | 29 out of 32 pass at 160 mmHg for level 3 | Pass
32 out of 32 pass at 160 mmHg, 3 lots |
| Particulate Filtration Efficiency | | ≥ 98% | Pass
minimum 99.21% |
| Bacterial Filtration Efficiency | | ≥ 98% | Pass
99.9% |
| Differential Pressure | |