(149 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard face mask, with no mention of AI or ML.
No
The device is a face mask intended for infection control to protect against transfer of microorganisms and fluids, not for treating a disease or condition.
No
The device is a face mask intended to protect against the transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines physical components made of materials like polypropylene, polyester, elastane, and polyethylene wire, indicating it is a physical medical device, not software-only.
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 of the body.
- Device Function: The description clearly states the face mask is intended to be worn to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Intended Use: The intended use is for infection control practices to reduce exposure, not to diagnose or provide information about a person's health based on a specimen.
- Device Description: The description focuses on the materials and construction of the mask itself, not on any components or processes related to analyzing biological samples.
- Performance Studies: The performance studies listed (fluid resistance, filtration efficiency, flammability, biocompatibility) are all related to the physical barrier properties and safety of the mask when worn, not to diagnostic capabilities.
Therefore, based on the provided information, this procedure face mask is a medical device, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Procedure 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 Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. which is made of malleable polyethylene wire. The face masks will be provided in blue. The 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing summary:
- Fluid Resistance Performance (mmHg) ASTM F1862: Passed at 120mm Hg (Acceptance Criteria for Level 2: 29 out of 32 pass at 120 mmHg) - PASS
- Particulate Filtration Efficiency Performance (%) ASTM F2299: Passed at 99.8% (Acceptance Criteria for Level 2: >= 98%) - PASS
- Bacterial Filtration Efficiency Performance (%) ASTM F2101: Passed at 99.8% (Acceptance Criteria for Level 2: >= 98%) - PASS
- Differential Pressure (Delta-P) (mm H2O/cm2) MIL-M-36954C: Passed at 3.8 mmH2O/cm2 (Acceptance Criteria for Level 2:
§ 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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 13, 2021
Han Zhaoqing Sporting Goods Company Limited % 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: K202314
Trade/Device Name: Procedure face mask (Model: KKF-2A) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: August 11, 2020 Received: August 17, 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 and Part 809); 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.
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) K202314
Device Name Procedure face mask (Model: KKF-2A)
Indications for Use (Describe)
The Procedure 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| ☐ Residential Use For 24 CFR 583.300 Subpart D Purposes | ☑ Own Use Construction (24 CFR 583.300 Subpart C) |
|---|---|
| --------------------------------------------------------- | --------------------------------------------------- |
| | 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
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
Subject Device: Procedure face mask (Model: KKF-2A) 510(k) Number: K202314
1. Date of the summary prepared: December 30, 2020
2. Submitter's Information
510(k) Owner's Name: Han Zhaoqing Sporting Goods Company Limited Establishment Registration Number: 3016690756 Address: NO.2-1, Kang tai Street, High-tech zone, Zhaoging City, Guangdong Province, P.R.China Contact Person: Zhang Ming Email: info@koumask.co
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
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common Name: Surgical Face Mask Trade Name: Procedure face mask Model Name: KKF-2A Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Requlatory Class: II
4. Predicate Device Information
Sponsor: Wuhan Dymex Healthcare Co., Ltd Trade Name: Surqical Face Mask Classification Name: Mask, Surqical 510(K) Number: K182515 Review Panel: General Hospital Product Code: FXX Requlation Number: 878.4040 Regulatory Class: II
5. Indications for Use
The Procedure 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
4
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.
6. Device Description
The Procedure face mask is a three-layer, flat-pleated style mask with ear loops and nose piece design for fitting the face mask around the nose and mouth. The proposed device is manufactured with three layers, the inner (Layer #3) and outer (Layer #1) layers are made of spun-bond polypropylene, and the middle layer (Filter layer) is made of melt-blown polypropylene. The ear loops are made of Polyester & elastane, and the nose piece is made of Malleable polyethylene wire. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose. which is made of malleable polyethylene wire. The face masks will be provided in blue. The face masks are sold non-sterile and are intended to be single-use, disposable devices.
7. Summary of Technological Characteristics
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 | Result | |
|---|---|---|---|---|
| Company | Han Zhaoqing Sporting Goods Company Limited | Wuhan Dymex Healthcare Co., Ltd | -- | |
| 510 (k) Number | K202314 | K182515 | -- | |
| Trade Name | Procedure face mask | Surgical Face Mask | -- | |
| Classification Name | Mask, Surgical | Mask, Surgical | Same | |
| Classification | Class II Device, FXX (21 CFR 878.4040) | Class II Device, FXX (21 CFR 878.4040) | Same | |
| Indication for use | The Procedure 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. | 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. | Same | |||
| Model | KKF-2A | |||
| (Ear Loops, Flat Pleated, 3 Layers) | Ear Loops, Flat Pleated, 3 layers | Same | ||
| Material | Outer facing layer | |||
| Spun-bond polypropylene | Spun-bond polypropylene | Same | ||
| Middle layer | ||||
| Melt blown polypropylene filter | Melt blown polypropylene filter | Same | ||
| Elements of Comparison | Subject Device | Predicate Device | Result | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | Malleable polyethylene wire | Malleable polyethylene wire | Same | |
| Ear loops | Polyester & elastane | Spandex | Similar | |
| Note 1 | ||||
| Color | Blue | Yellow | Similar | |
| Note 1 | ||||
| Dimensions | Length: 17.5 cm ± 2 cm | |||
| Width: 9.5 cm ± 2 cm | ||||
| Length of Nose piece: 10cm | ||||
| Length of Ear loop (for single side): 20cm | Length: 17.5 cm ± 0.2 cm | |||
| Width: 9.0 cm ± 0.2 cm | Similar | |||
| Note 1 | ||||
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Fluid Resistance Performance | Passed at 120mm Hg | 32 out of 32 pass at 120 mm Hg | Same | |
| Particulate Filtration Efficiency | Passed at 99.8% | 99.7% | Similar | |
| Note 2 | ||||
| Bacterial Filtration Efficiency | Passed at 99.8% | 99.9% | Similar | |
| Note 2 | ||||
| Differential Pressure | Passed at 3.8 mmH2O/cm² | 4 mmH2O/cm² | Similar | |
| Note 1 | ||||
| Flammability | Class 1 | Class 1 | Same | |
| Cytotoxicity | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Under the conditions of the study, the device is noncytotoxic. | Same | |
| Biocompatibility | 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 device is nonirritating. | 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 device is nonsensitizing. | Same |
5
Comparison in Detail(s):
Note 1:
Although the "Ear loops", "Size and Dimensions" and "Color" of subject device is a little different from the predicate device, and they all meet the requirements of essential performance standard ASTM F2100 and ISO 10993 series. So, 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", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from the predicate device, and they all meet the requirements of essential
6
performance standard ASTM F2100. So, the differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
8. Summary of Non-Clinical Performance Testing Performance Testing summary:
| Item | Proposed device | Acceptance Criteria
for Level 2 | Test
Results |
|--------------------------------------------------------------------|----------------------------|------------------------------------|-----------------|
| Fluid Resistance Performance
(mmHg)
ASTM F1862 | Passed at 120mm Hg | 29 out of 32 pass at 120
mmHg | PASS |
| Particulate Filtration Efficiency
Performance (%)
ASTM F2299 | Passed at 99.8% | ≥ 98% | PASS |
| Bacterial Filtration Efficiency
Performance (%)
ASTM F2101 | Passed at 99.8% | ≥ 98% | PASS |
| Differential Pressure (Delta-P)
(mm H2O/cm2)
MIL-M-36954C | Passed at 3.8
mmH2O/cm2 |