(112 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that it is a medical surgical mask for infection control, protecting against the transfer of microorganisms, body fluids, and particulate material, not for treating any condition or disease.
No
The device is a medical surgical mask, which is used for infection control by creating a physical barrier to transfer microorganisms and particulate material, not for diagnosing conditions.
No
The device description clearly outlines a physical medical device (a surgical mask) made of specific materials and dimensions, with performance studies related to filtration and fluid resistance, not software functionality.
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 product is for "infection control practices in the health care industry" and is intended to "protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material." This describes a physical barrier device, not a device used to examine specimens taken from the human body to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description details the physical construction of a surgical mask, including materials, dimensions, and components like ear loops and a nose clip. This aligns with a physical barrier device.
- Performance Studies: The performance studies focus on the physical properties and protective capabilities of the mask, such as filtration efficiency, differential pressure, resistance to synthetic blood, and flame spread. These are relevant tests for a surgical mask, not for an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or providing diagnostic information.
In summary, the device described is a surgical mask, which is a medical device used for personal protection and infection control, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, the Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical surgical mask is a flat style face mask with ear loops and nose clip for fitting around the nose and mouth. The Medical surgical mask has three layers are made of polypropylene nonwoven and the middle layer is made of polypropylene melt-blown. The outer layer is blue, and the colorant material is identified as Pigment Blue K6911D /CAS number: 12239-87-1. The face mask is held in place over the users' nose and mouth by two polyester and spandex elastic bands as ear loops welded to the face mask. The nose clip is made of iron-cored polypropylene, which allows the users to fit the mask around their nose area.
The dimensions of each mask are 175±5 mm in width. The density of the inner and outer layer is 25 gsm, and the density of the middle layer is 35 gsm. The dimensions of nosepiece are 100±5 mm in length and 3±0.5 mm in width. The ear loop is 175±10 mm in length and 3.5±0.5 mm in width. The Medical surgical mask is sold nonsterile and is 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
health care industry, health care facilities
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)
Summary of Non-Clinical Tests Performed
- Bacterial filtration efficiency
- Test method: ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019
- Pass criteria: ≥ 98%
- Test results /Verdict: 99.65% / Pass
- Differential pressure (Delta-P)
- Test method: EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019
- Pass 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
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 20, 2020
Guangdong Kingfa SCI.&Tech.Co., Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202139
Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2020 Received: October 22, 2020
Dear Cassie Lee:
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.
1
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 (OS) 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 CAPT Elizabeth Claverie, M.S. 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) K202139
Device Name Medical Surgical Mask (Model: KF-B P05(L3))
Indications for Use (Describe)
This product is indicated for infection control practices in the health care industry. When worn properly, the Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(K) Summary
K202139
prepared in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: GUANGDONG KINGFA SCI. & TECH.CO., LTD.
Establishment Registration Number: 3016785267
Address: NO.28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China
Post Code: 511500
Contact Person: Yu Xiaoge
Tel: +86 13570952157
Fax: +0763-3203108
Email: yuxiaoge@kingfa.com.cn
Application Correspondent:
Contact Person: Ms. Cassie Lee, Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China
Tel: +86 20 8266 2446
Email: regulatory@glomed-info.com
Date of preparation: October 15, 2020
2. Subject Device Information
Type of 510(k): Traditional
Classification Name: Mask, Surgical
Trade Name: Medical surgical mask
Model Name: KF-B P05(L3)
Review Panel: General Hospital
Product Code: FXX
Regulation Number: 878.4040
Regulatory Class: 2
3. Predicate Device Information
Sponsor: H&H RESEARCH COMPANY Trade Name: The New Medical Mask
Classification Name: Mask, Surgical
510(K) Number: K093179
Review Panel: General Hospital Product Code: FXX
Regulation Number: 878.4040
Regulation Class: 2
4
4. Device Description
The Medical surgical mask is a flat style face mask with ear loops and nose clip for fitting around the nose and mouth. The Medical surgical mask has three layers are made of polypropylene nonwoven and the middle layer is made of polypropylene melt-blown. The outer layer is blue, and the colorant material is identified as Pigment Blue K6911D /CAS number: 12239-87-1. The face mask is held in place over the users' nose and mouth by two polyester and spandex elastic bands as ear loops welded to the face mask. The nose clip is made of iron-cored polypropylene, which allows the users to fit the mask around their nose area.
The dimensions of each mask are 175±5 mm in width. The density of the inner and outer layer is 25 gsm, and the density of the middle layer is 35 gsm. The dimensions of nosepiece are 100±5 mm in length and 3±0.5 mm in width. The ear loop is 175±10 mm in length and 3.5±0.5 mm in width. The Medical surgical mask is sold nonsterile and is intended to be single use, disposable device.
5. Intended Use / Indications for Use
The Medical surgical mask is indicated for infection control practices in the health care facilities. When worn properly, the Medical surgical mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
| Elements of | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Comparison | |||
| Company | GUANGDONG KINGFA SCI.&TECH.CO., | ||
| LTD. | H&H RESEARCH COMPANY | -- | |
| 510 (k) | K202139 | K093179 | -- |
| Trade Name | Medical surgical mask | The New Medical Mask | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Identical |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Identical |
| Intended use/ | |||
| Indications for | |||
| Use | This product is indicated for infection | ||
| control practices in the health care | |||
| industry. When worn properly, The | |||
| Medical surgical mask is intended to | |||
| protect both patient and wearer from the | |||
| transfer of microorganisms, body fluids | |||
| and particulate material. | This product is indicated for infection | ||
| control practices in the health care | |||
| industry. When worn properly, The | |||
| New Medical Mask is intended to | |||
| protect both patient and wearer from | |||
| the transfer of microorganisms, body | |||
| fluids and particulate material. | Identical | ||
| Material | |||
| Outer facing | |||
| layer | Polypropylene | Polypropylene | Identical |
| Middle layer | Polypropylene melt-blown | Polypropylene | Similar |
| Note 1 | |||
| Inner facing | |||
| layer | Polypropylene | Polypropylene | Identical |
| Nose clip | Iron core polypropylene strip | Adhesive tape | Different |
| Note 1 | |||
| Ear Loops | Polyester and spandex elastic bands | Non-latex elastic ear bands | Different |
| Note 1 | |||
| Design | |||
| features | Color: blue | Color: blue | Identical |
| Mask Style | Ear loop flat style | Ear loop flat style | Identical |
| Specification | |||
| and | |||
| Dimension | 17.5cm×9.5cm | Length: 7.1 inches (18 cm) | |
| Width: 3.9 inches (10 cm) | Similar | ||
| Note 1 |
6. Comparison to predicate device and conclusion
5
| OTC use | Yes | Yes | Identical |
|---|---|---|---|
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| Protection | |||
| level | Level 3 | Level 3 | Identical |
| Fluid | |||
| Resistance | |||
| Performance | Pass at 160 mmHg | Pass at 160 mmHg | Identical |
| Particulate | |||
| Filtration | |||
| Efficiency | 99.65% | 99.9% | Similar |
| Note 2 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency | >99.9% | >99.9% | Identical |
| Differential | |||
| Pressure | On average of 3.72 mm H2O/cm² | Pass at 2.7 mmH2O/cm² | Similar |
| Note 2 | |||
| Flammability | Class 1 | Class 1 | Identical |
| Latex | Not Made with Natural Rubber Latex | Not Made with Natural Rubber Latex | Identical |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of the study, the | ||
| subject device extract was determined to | |||
| be non-cytotoxic. | Under the conditions of the study, the | ||
| subject device extract was determined | |||
| to be non-cytotoxic. | Identical | ||
| Irritation | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be non- | |||
| irritating. | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be non- | |||
| irritating. | Identical | ||
| Sensitization | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be | |||
| non-sensitizing. | Under the conditions of the study, the | ||
| subject device non-polar and polar | |||
| extracts were determined to be non- | |||
| sensitizing. | Identical |
Note 1:
Although the "Middle layer", "Nose clip", "Ear Loops" and "Specification and Dimension" of subject device is slightly difference with predicate device, it meets the requirement standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "Particulate Filtration Efficiency" and "Differential Pressure" of subject device is with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affectiveness of the subject device.
7. Summary of Non-Clinical Tests Performed
| Test Performance | Test method | Pass criteria | Test results /Verdict |
|---|---|---|---|
| Bacterial filtration | |||
| efficiency | ASTM F2101-14 Standard Test Method for | ||
| Evaluating the Bacterial Filtration | |||
| Efficiency (BFE) of Medical Face Mask | |||
| Materials, Using a Biological Aerosol of | |||
| Staphylococcus aureus according to ASTM | |||
| F2100:2019 | $\geq 98%$ | 99.65% / Pass |
6
| Differential pressure
(Delta-P) | EN 14683: 2019, Annex C Medical face masks -
Requirements and test methods according to
ASTM F2100:2019 |