(197 days)
Not Found
No
The device is a standard surgical mask and the summary does not mention any AI or ML components.
No.
A therapeutic device is intended to treat or cure a disease or condition. This device is a surgical mask intended for protecting against the transfer of microorganisms, bodily fluids, and particulate matter, which is a preventive measure, not a treatment.
No
The device, a medical surgical mask, is intended for protection against the transfer of microorganisms and bodily fluids, not for diagnosing medical conditions. The performance studies and key metrics listed describe physical properties and barrier efficacy, not diagnostic capabilities.
No
The device description clearly states it is a "flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting". This describes a physical, hardware device, not software.
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 the body.
- Device Intended Use: The intended use of this device is to protect healthcare workers and patients from the transfer of microorganisms, bodily fluids, and particulate matter during procedures. This is a barrier function, not a diagnostic function.
- Device Description: The description details a physical barrier (mask) worn on the face.
- Performance Studies: The performance studies focus on the physical properties of the mask as a barrier (filtration efficiency, resistance to penetration, flammability, biocompatibility), not on analyzing biological samples.
The device described is a medical surgical mask, which is a personal protective equipment (PPE) device used to prevent the spread of infection. It does not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose.
The Medical surgical mask is provided non-sterile and is intended to be a 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 workers
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 specification. 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 Mask-Premarket Notification [510(K)] Submission issued on March 5, 2004:
- ASTM F2100 Standard Specification for Performance of Materials Used in . Medical Face Masks
- 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 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 Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Bacterial Filtration Efficiency ASTM F2101 | Measure bacterial filtration efficiency | >=95% | Pass |
| Differential Pressure(mmH2O/cm²) EN14683:2019 Annex C | Determine breathability of the mask | =95% | Pass |
| Resistance to Penetration by Synthetic Blood ASTM F1862-17 | Evaluate the resistance to penetration by impact of small volume of synthetic blood | 29 out of 32 pass at 80 mmHg | Pass |
| Flammability 16 CFR Part 1610-2008 | Response of materials to heat and flame | Class 1 | Pass |
| In vitro Cytotoxicity ISO 10993-5 | Verify that the proposed device extract is non-cytotoxic. | The extract is non-cytotoxic under the research conditions. | Pass |
| Skin Irritation ISO 10993-10 | Verify that the proposed device extract is non-irritating. | The polar and non-polar extracts are non-irritating under the research conditions. | Pass |
| Skin Sensitization ISO 10993-10 | Verify that the proposed device extract is non-sensitizing. | The polar and non-polar extracts are non-sensitizing under the research conditions. | Pass |
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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 7, 2023
Guangdong Kingfa Sci. & Tech. Co., Ltd. Xiaoge Yu Manager No.28, Delong Ave., Shijiao Town, Qingcheng District Oingyuan, Guangdong 511545 China
Re: K231155
Trade/Device Name: Biodegradable Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 7, 2023 Received: September 27, 2023
Dear Xiaoge Yu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 mediation-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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Biodegradable Medical surgical mask
Indications for Use (Describe)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and 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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3
Section 3-510(k) summary
l. Submitter
GUANGDONG KINGFA SCI. & TECH.CO., LTD. No. 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province 511545, China
Contact person: Xiaoge Yu Position: Manager Tel.: +86-13570952157 E-mail: yuxiaoge@kingfa.com.cn
Preparation date: January 10, 2023
II. Proposed Device
| Device Trade Name: | Biodegradable Medical surgical mask |
|---|---|
| Common name: | Medical surgical mask |
| Regulation Number: | 21 CFR 878.4040 |
| Regulatory Class: | Class II |
| Product code: | FXX |
| Review Panel: | Surgical Apparel |
III. Predicate Devices
| 510(k) Number: | K201622 |
|---|---|
| Trade name: | Medical surgical mask |
| Common name: | Medical surgical mask |
| Classification: | Class II |
| Product Code: | FXX |
| Manufacturer | GUANGDONG KINGFA SCI. & TECH.CO., LTD |
IV. Device description
The Medical surgical mask is flat pleated style mask, utilizing ear loops way for wearing, and has nose piece design for fitting the Medical surgical mask around the nose.
The Medical surgical mask is provided non-sterile and is intended to be a single use, disposable device.
4
V. Indication for use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
VI. Comparison of technological characteristics with the predicate devices
| Item | Proposed device | Predicate device
(K201622) | Discussion |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|
| Trade name | Biodegradable Medical
surgical mask | Medical surgical mask | - |
| Product code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Classification | Class II | Class II | Same |
| Indication for use | Medical surgical mask is
intended for use by
healthcare
workers
during procedures to
protect both patients
and healthcare workers
against transfer
of
microorganisms, bodily
fluids, and particulate
matters. This device is
single use and provided
non-sterile. | Medical surgical mask is
intended for use by
healthcare
workers
during procedures to
protect both patients and
healthcare workers
against transfer
of
microorganisms, bodily
fluids, and particulate
matters. This device is
single use and provided
non-sterile. | Same |
| Mask Style | Ear loop flat | Ear loop flat | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Biodegradation
Properties | Biodegradable | None | Different
Note 1 |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Outer facing layer | Polylactic acid | Spun-bond
polypropylene | Different
Note 1 |
| Middle layer | Melt-blown polylactic acid | Melt polypropylene | blown |
| Inner facing layer | Polylactic acid | Spun-bond polypropylene | |
| Product performance | | | |
| Performance Testing (according to ASTM-2100) | Level 1 | Level 1 | Same |
| Biocompatibility | ISO 10993-5 and ISO 10993-10.
Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | ISO 10993-5 and ISO 10993-10.
Under the conditions of the study, the proposed device extract was determined to be non-cytotoxic, non-sensitizing, and non-irritating. | Same |
Table 1 Comparison of Medical surgical mask
5
Note 1:
Although the "Biodegradation Properties" and "Material" of proposed device are different from the predicate devices, non-clinical performance tests and the biocompatibility tests have been performed on the proposed device according to ASTM F2100, ISO 10993-5 and ISO 10993-10. The results do not show any adverse effect.
Biodegradability is not a medical claim and therefore was not reviewed by FDA.
VII. Non-Clinical Testing
Non-clinical tests were conducted to verify that the proposed device met all design specification. 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 Mask-Premarket Notification [510(K)] Submission issued on March 5, 2004:
- ASTM F2100 Standard Specification for Performance of Materials Used in . Medical Face Masks
- ISO 10993-5:2009, Biological evaluation of medical devices Part 5: Tests for in ●
6
vitro cytotoxicity
- o ISO 10993-10:2010, Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
- 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 o
- 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 o Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres
- 16 CFR 1610, Standard for the Flammability of Clothing Textiles ●
| Test Method | Purpose | Acceptance Criteria | Results |
|---|---|---|---|
| Bacterial Filtration | |||
| Efficiency ASTM F2101 | Measure bacterial filtration | ||
| efficiency | ≥95% | Pass | |
| Differential | |||
| Pressure(mmH2O/cm²) | |||
| EN14683:2019 Annex C | Determine breathability of | ||
| the mask |