(124 days)
Not Found
No
The device is a physical surgical mask and the description focuses on its materials and physical properties, with no mention of AI or ML.
No.
Justification: Therapeutic devices are generally used for diagnosis, treatment, or prevention of disease. This device is a surgical mask intended to protect against the transfer of microorganisms and fluids, placing it in the category of protective equipment for infection control, not a therapeutic device.
No
The device is a surgical mask intended for protection and infection control, not for diagnosing medical conditions.
No
The device description clearly outlines physical components (spun-bond polypropylene, melt blown polypropylene filter, elastic ear loops, galvanized wire with polypropylene) and the testing performed is related to the physical properties and performance of a surgical mask, not software.
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 mask is for protecting against the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose clip). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of Diagnostic Function: The device does not perform any tests on biological samples (like blood, urine, tissue, etc.) to diagnose a condition, monitor a disease, or screen for a health issue.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are not diagnostic performance metrics.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This surgical mask does not fit that definition.
N/A
Intended Use / Indications for Use
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), provided non-sterile.
Product codes
FXX
Device Description
The proposed devices (model: KH8001& KH8002) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with 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 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyester fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices 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
healthcare personnel
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 specifications as was similar to the predicate device. Provided below in Table 2 is the summary of the non-clinical testing that was performed per specification of the standard and test methodology using 3 non-consecutive lots with 32 samples for each lot listed below. The results of the performance testing demonstrated the subject device met the acceptance criteria of the standard and the test methodologies summarized below. The test results demonstrated that the proposed device complies with the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
-
ASTM F2101-19, Differential Pressure, mm H2O/cm2:
- Purpose: Measuring the pressure of dropping across a medical face mask material.
- Acceptance Criteria: 98%
- Results: Level 3: passed at 99.8%; Level 2: passed at 99.9%
-
ASTM F2299-17, Standard test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres:
- Purpose: Testing the efficiency of the filter material in capturing aerosolized particles smaller than one micron.
- Acceptance Criteria: >98%
- Results: Level 3: passed at 99.5%; Level 2: passed at 99.6%
-
16 CFR 1610, Standard for the Flammability of clothing textiles:
- Purpose: Testing the characteristics of a material that pertain to its relative ease of ignition and relative ability to sustain combustion.
- Acceptance Criteria: Class 1
- Results: Met Class 1
-
ISO 10993-5:2009, Biological Evaluation of Medical Devices, Part 5: Tests for In-Vitro Cytotoxicity:
- Purpose: Assess the biological response of mammalian cells in vitro in contact with a device or extracts of a device
- Acceptance Criteria: Non-Cytotoxic under the conditions of the study
- Results: Passed, Non-Cytotoxic under the conditions of the study
-
ISO 10993-10:2010, Biological Evaluation of Medical Devices, Part 10: Tests for Irritation and Sensitization:
- Purpose: Assess medical devices and their constituent materials for their potential to produce skin irritation or sensitization in animal models
- Acceptance Criteria: Non-Irritating and Non-Sensitizing under the conditions of the study
- Results: Passed, Non-Irritating and Non-Sensitizing under the conditions of the study
No clinical study is included in this submission.
Key Metrics
- Fluid Resistance Performance: 32 out of 32 pass at 120mmHg; 32 out of 32 pass at 160mmHg
- Particulate Filtration Efficiency: ≥ 98%
- Bacterial Filtration Efficiency: ≥ 98%
- Differential Pressure (Delta P):
§ 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 shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
August 28, 2021
Tianchang Kanghui Protective Products CO LTD % Ivy Wang Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K211255
Trade/Device Name: Surgical Mask (model: KH8001& KH8002) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 18, 2021 Received: August 18, 2021
Dear Ivy 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.
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
1
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,
Clarence W. Murray, III, PhD 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) K211255
Device Name Surgical Mask (model: KH8001& KH8002)
Indications for Use (Describe)
The Surgical Mask (model: KH8001& KH8002) is intended to be worn to protect both the patient and healtheare personnel from transfer of microorganisms, body fluids and particulate material. These face intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This a single use, disposable device(s), 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)
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 K211255
Document prepared date: 8/25/2021
A. Applicant
Name: TIANCHANG KANGHUI PROTECTIVE PRODUCTS CO., LTD. Address: NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI Contact Person: Mark Wong Tel: +86-015255006789 Mail: mark@kanghuimedical.com
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: haiyu.wang@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 Mask Common Name: Surgical Face Mask Model: KH8001,KH8002
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
| 510K | Device name | ASTM F2100-19
Level | Manufacturer |
|---------|-----------------------------------|------------------------|----------------------------------------------------------|
| K203685 | Disposable Surgical Face
Masks | Level 3, Level 2 | Xiantao Zhongyi Safety & Protection
Products Co., Ltd |
D. Indications for use of the device:
4
The Surgical Masks (model: KH8001& KH8002) 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 a single use, disposable devices, provided non-sterile.
E. Device Description:
The proposed devices (model: KH8001& KH8002) are White color, and Flat Pleated type mask, utilizing Ear Loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed devices are manufactured with 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 model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of polyester fiber and spandex. The nose piece in the proposed devices is made of Galvanized wire with polypropylene and is contained within the layers of face mask to allow the user to fit the face mask around their nose. The proposed devices are sold non-sterile and are intended to be single use, disposable devices.
F. Technical Characteristic Comparison
Table 1 Summary of Technological Characteristics
| Device | Proposed Device | Predicted Device | Comparison | |
|---|---|---|---|---|
| Manufacturer | TIANCHANG KANGHUI | |||
| PROTECTIVE | ||||
| PRODUCTS CO.,LTD. | Xiantao Zhongyi Safety & | |||
| Protection Products Co., Ltd | - | |||
| 510K number | K211255 | K203685 | - | |
| Classification | Class II Device, FXX (21 | |||
| CFR878.4040) | Class II Device, FXX (21 | |||
| CFR878.4040) | Same | |||
| Indications for use | The Surgical Masks (model: | |||
| KH8001& KH8002) 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 | ||||
| a single use, disposable device(s), | ||||
| provided non-sterile. | The Disposable Surgical Face | |||
| Masks (model: ZYD- 02 & ZYD- |
- 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 a single
use, disposable device(s),
provided non-sterile. | Similar |
| Outer | | spun-bond polypropylene | Spun-bond polypropylene | Same |
| NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI | | | | |
| | Middle | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Material | Inner | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| | Nose
clip | Galvanized wire
with polypropylene | Polypropylene and Iron | Different |
| | Ear
loops | polyester fiber and spandex | Spandex | Different |
| Color | | White | Blue | Different |
| Dimension
(Length) | | $17.5+/-0.3cm$ | $17.5 cm +/- 0.5 cm$ | Similar |
| Dimension
(Width) | | $9.0+/-0.3cm$ | $9.5 cm +/- 0.5 cm$ | Similar |
| 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 3 | Level 2, Level 3 | Same |
| Fluid Resistance
Performance | | 32 out of 32 pass
at 120mmHg;
32 out of 32 pass
at 160mmHg; | 32 out of 32 pass at
120mmHg;
32 out of 32 pass at
160mmHg; | Same |
| Efficiency | Particulate Filtration | ≥ 98% | ≥ 98% | Same |
| Bacterial Filtration
Efficiency | | ≥ 98% | ≥ 98% | Same |
| Differential
Pressure (Delta P) | | 98% | Level 3: passed at 99.8%
Level 2: passed at
99.9% |
| ASTM F2299-17, Standard
test method for determining
the initial efficiency of
materials used in medical
face masks to penetration by | Testing the efficiency of the
filter material in capturing
aerosolized particles smaller
than one micron. | >98% | Level 3: passed at 99.5%
Level 2: passed at
99.6% |
Table 2: Summary of Non-Clinical Testing
7
| NO.16 WAYECONOMIC DEVELOPMENT ZONE, TIANCHANG, ANHUI | |||
|---|---|---|---|
| particulates using latex | |||
| spheres | |||
| 16 CFR 1610, Standard for | |||
| the Flammability of clothing | |||
| textiles | Testing the characteristics of a | ||
| material that pertain to its | |||
| relative ease of ignition and | |||
| relative ability to sustain | |||
| combustion. | Class 1 | Met Class 1 | |
| ISO 10993-5:2009, | |||
| Biological Evaluation of | |||
| Medical Devices, Part 5: | |||
| Tests for In-Vitro | |||
| Cytotoxicity | Assess the biological response | ||
| of mammalian cells in vitro in | |||
| contact with a device or | |||
| extracts of a device | Non-Cytotoxic under the | ||
| conditions of the study | Passed, Non- | ||
| Cytotoxic under | |||
| the conditions of | |||
| the study | |||
| ISO 10993-10:2010, | |||
| Biological Evaluation of | |||
| Medical Devices, Part 10: | |||
| Tests for Irritation and | |||
| Sensitization | Assess medical devices and | ||
| their constituent materials for | |||
| their potential to produce skin | |||
| irritation or sensitization in | |||
| animal models | Non-Irritating and | ||
| Non-Sensitizing | |||
| under the | |||
| conditions of the | |||
| study | Passed, Non- | ||
| Irritating and Non- | |||
| Sensitizing under | |||
| the conditions of | |||
| the study | |||
| ISO 10993-10:2010, | |||
| Biological Evaluation of | |||
| Medical Devices, Part 10: | |||
| Tests for Irritation and | |||
| Sensitization | Assess medical devices and | ||
| their constituent materials for | |||
| their potential to produce skin | |||
| irritation or sensitization in | |||
| animal models | Non-Irritating and | ||
| Non-Sensitizing | |||
| under the | |||
| conditions of the | |||
| study | Passed, Non- | ||
| Irritating and Non- | |||
| Sensitizing under | |||
| the conditions of | |||
| the study |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K211255, Surgical Mask, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K203685.