(170 days)
Not Found
No
The description focuses on the physical construction and filtration properties of a medical mask, with no mention of AI or ML capabilities.
No.
The device description indicates its purpose is to protect against microorganisms, body fluids, and particulate material, and not to treat or diagnose a disease or condition.
No
This device is a protective mask designed to prevent the transfer of microorganisms and body fluids. It does not perform any diagnostic functions like detecting, identifying, or monitoring medical conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt-blown polypropylene, spandex, polyester, iron core) and physical dimensions, indicating it is a hardware device. The performance studies also focus on physical properties like filtration efficiency and resistance to penetration.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections. They are used outside of the body (in vitro).
- Device Description and Intended Use: The description and intended use clearly state that this is a Medical Protective Mask intended to be worn on the face to filter microorganisms, body fluids, and particulate material. It is a physical barrier device.
- No Mention of Samples or Testing: The document does not mention any testing of biological samples or any diagnostic procedures.
- Performance Studies: The performance studies listed (filtration efficiency, pressure, resistance to blood, flame spread, biocompatibility) are all related to the physical properties and safety of the mask as a barrier, not to diagnostic testing.
Therefore, based on the provided information, this device is a medical device (specifically, a protective mask) but not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask 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, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use. The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively. The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was conducted including:
- Bacterial filtration efficiency: Passed with 99.1% efficiency, meeting the ASTM F2100 level 2 requirement of >= 98%.
- Differential pressure (Delta-P): Passed with an average of 5.04 mm H2O/cm², meeting the ASTM F2100 level 2 requirement of = 98%.
- Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result: Passed, claimed at 120 mm Hg, meeting the ASTM F2100 level 2 requirement.
- Flame spread: Passed, Class 1, meeting the ASTM F2100 level 2 requirement for Class 1.
- Shelf-life: Passed, meeting the requirements of ASTM F2100 level 2 after 2 years of aging.
- Biocompatibility Testing (ISO 10993-1:2009):
- In vitro Cytotoxicity Test: Passed, determined to be non-cytotoxic.
- Skin Sensitization Test: Passed, determined to be non-sensitizing.
- Skin Irritation Test: Passed, determined to be non-irritating.
No clinical study was included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Bacterial filtration efficiency: 99.1%
- Differential pressure: On average of 5.04 mm H2O/cm²
- Sub-micron particulate filtration efficiency at 0.1 µm of Polystyrene Latex Spheres: 99.9%
- Flame spread: Class 1
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.
January 15, 2021
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: K202107
Trade/Device Name: Medical Protective Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 17, 2020 Received: December 28, 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) K202107
Device Name Medical Protective Mask (Model: KF-A F02(N))
Indications for Use (Describe)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask 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, provided nonsterile.
| Type of Use (Select one or both, as applicable) | Reproduction Use (21 CFR 201 Subpart D) Own-Use Compounding (21 CFR 201 Subpart G) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
__ 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 for K202107
This summary of 510(K) safety and effectiveness information is being submitted 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
2. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Medical Protective Mask Model Name: KF-A F02(N) Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
3. Predicate Device Information
Sponsor: Shandong Shengquan New Material Co., Ltd. Trade Name: Protective Face Mask for Medical Use Common name: Surgical Mask Classification Name: Mask, Surgical 510(K) Number: K201537
4
Review Panel: General & Plastic Surgery Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
4. Device Description
The Medical Protective Mask is a single use, two-panel, flat-folded mask with ear loops and nose piece. The mask is designed into a C-shape when flat-folded. The C-shaped design allows for an expanded chamber for the mask in use.
The mask materials include four layers, the inner and outer layers are made of spun-bond polypropylene, and the two middle layers are melt-blown polypropylene and non-woven polypropylene filters, respectively.
The elastic ear loops are made of spandex and polyester, which are welded to the facemask to hold the mask in place over the users' mouth and nose. The elastic ear loops are not made with natural rubber latex. The nose piece is a Iron core covered with polypropylene. The dimensions of each mask are length 162±5 mm and width 102±5 mm. The dimensions of nosepiece is length 90±10 mm and width 5±0.5 mm, and the ear loop is length 185±5 mm and width 5±0.5 mm. The mask is a single use, disposable device, provided non-sterile in white color.
5. Intended Use / Indications for Use
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask 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, provided non-sterile.
6. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | GUANGDONG KINGFA | ||
| SCI.&TECH.CO., LTD. | Shandong Shengquan New | ||
| Material Co., Ltd. | -- | ||
| 510 (k) | K202107 | K201537 | -- |
| Trade Name | Medical Protective Mask | Protective Face Mask for | |
| Medical Use | -- | ||
| Model | KF-A F02(N) | -- | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 | Class II Device, FXX (21 | Same |
| Elements of Comparison | Subject Device | Predicate Device | Verdict |
| Intended use/ Indication for Use | CFR878.4040) | ||
| The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Medical Protective Mask 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, provided non-sterile. | CFR878.4040) | ||
| The Protective Face Mask for Medical Use is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The face mask 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, provided non-sterile. | Same | ||
| Material | |||
| Outer facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Polypropylene non-woven fabric | ||
| Melt-blown polypropylene | Polypropylene non-woven fabric | ||
| Melt-blown polypropylene | Same | ||
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose clip | Iron core polypropylene strip | Plastic coated aluminum wire covered with sponge strips | Different |
| Note 1 | |||
| Ear Loops | Polyester and spandex | Polyester and spandex | Same |
| Design features | Color: white | Color: White | Same |
| Mask Style | Expanded chamber flat-folded, ear loops, 4 layers | Expanded chamber flat-folded, ear loops, 4 layers | Same |
| Specification and Dimension | Length: $16.2\pm0.5$ cm | ||
| Width: $10.2\pm0.5$ cm | Length: $16.5\pm0.8$ cm | ||
| Width: $10.5\pm0.5$ cm | Same | ||
| Note 2 | |||
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance Testing | ASTM F2100 Level 2 | ASTM F2100 Level 2 | Same |
| Fluid Resistance Performance | Pass at 120 mmHg | Pass at 120 mmHg | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| Particulate | |||
| Filtration | |||
| Efficiency | 99.1% | 99.22% | Similar |
| Note 3 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency | 99.9% | ≥9.89% | Similar |
| Note 3 | |||
| Differential | |||
| Pressure | On average of 5.04 mm H2O/cm² | Pass at 4.2 mmH2O/cm² | Similar |
| Note 3 | |||
| Flammability | Class 1 | Class 1 | Same |
| Latex | Not Made With Natural Rubber | ||
| Latex | Not Made With Natural Rubber | ||
| Latex | Same | ||
| 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. | Same | ||
| 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. | Same | ||
| 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 | Same |
5
6
Comparison in Detail(s):
Note 1:
Although the "Nose clip" 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 "Specification and Dimension" of subject device is slightly difference with predicate device. The differences between the predicate device and subject device is minimal, there may be some measurement errors, it will not affect the safety and effectiveness of the subject device.
Note 3:
7
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
7. Summary of Non-Clinical Performance Testing
Medical Protective Mask (Model: KF-A F02(N)) has been evaluated the safety and performance by lab bench testing as following:
- Performance Testing summary
| Title of the test | Purpose of the test | The source of references
(Test method) | Acceptance criteria | Test results /Verdict |
|-------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------|-----------------------------------------------|
| Bacterial filtration efficiency | In order to verify
whether the subject
equipment meets the
performance
requirements of
ASTM F2100 level 2,
Bacterial filtration
efficiency: $\ge$ 98% | 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 | $\ge$ 98% | 99.1% /
Pass |
| Differential
pressure
(Delta-P) | In order to verify
whether the subject
equipment meets the
performance
requirements of
ASTM F2100 level 2,
Differential pressure
(Delta-P):