(87 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device's intended use is to protect from transfer of microorganisms, body fluids, and particulate material in infection control practices, not for diagnosis, cure, mitigation, treatment, or prevention of disease.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layered face mask made of nonwoven and melt blown fabrics, with ear loops and a nose clip. This is a hardware device, 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 both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. It's used in infection control practices to reduce exposure. This is a physical barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of the mask (layers, materials, ear loops, nose clip). There are no components or mechanisms described that would be used to analyze samples from the human body (like blood, urine, tissue, etc.) to provide diagnostic information.
- Lack of Diagnostic Function: IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This mask does not perform any such analysis.
- Performance Studies: The performance studies focus on the physical barrier properties of the mask (filtration efficiency, fluid resistance, breathability, flammability) and biocompatibility. These are relevant to its function as a protective barrier, not as a diagnostic tool.
In summary, the device's purpose is to act as a physical barrier for protection, which is not the function of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Surgical Face Mask is 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 Proposed device(s) are blue 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 device(s) are manufactured with three layers, the inner and outer layers are made of nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). 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 and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene .iron and zinc. The proposed device(s) are sold nonsterile and are 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
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 tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. 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 Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A 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 A And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed VolumeAt A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand 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 clothingtextiles; A
Performance Testing included:
- Fluid Resistance Performance ASTM F1862 (sample size of 32/lot from 3 non-consecutive lots): 32 out of 32 pass at 120 mmHg. Result: PASS.
- Particulate Filtration Efficiency ASTM F2299 (sample size of 32/lot from 3 non-consecutive lots): Lot1: 98.21%, Lot2: 98.21%, Lot3: 98.16%. Result: PASS.
- Bacterial Filtration Efficiency ASTM F2101 (sample size of 32/lot from 3 non-consecutive lots): Lot1: 98.21%, Lot2: 98.24%, Lot3: 98.20%. Result: PASS.
- Differential Pressure (Delta P) EN 14683 Annex C (sample size of 32/lot from 3 non-consecutive lots): Lot1:2.52 mmH2O/cm², Lot2: 2.60 mmH2O/cm², Lot3: 2.60 mmH2O/cm². Result: PASS.
- Flammability 16 CFR 1610 (sample size of 32/lot from 3 non-consecutive lots): Class I. Result: PASS.
Biocompatibility Testing included:
- Cytotoxicity: PASS (non-cytotoxic).
- Irritation: PASS (non-irritating).
- Sensitization: PASS (non-sensitizing).
No clinical study is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 shows 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.
June 1, 2023
Henan Chaoya Medical Equipment Co., Ltd. % Jarvis Wu Consultant Shanghai Sungo Management Consulting Company Limited 14th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K230617
Trade/Device Name: Surgical Face Mask (L 175*95mm) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: March 6, 2023 Received: March 6, 2023
Dear Jarvis Wu:
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 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
Indications for Use
510(k) Number (if known) K230617
Device Name Surgical Face Mask (L 175*95mm)
Indications for Use (Describe)
The Surgical Face Mask is 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 ininfection 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) | |
|---|---|
| | Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary K230617
Document Date Prepared:2023/5/15
A. Applicant:
Name: Henan Chaoya Medical Equipment Co., Ltd.
Address: No. 19, 13th Street, Economic and Technological Development, Zhengzhou, Henan, China Contact Person: Ruihua Miao Tel: +86 18039303229 EMail: 949940319@qq.com
Submission Correspondent:
Primary contact: Mr. Jarvis Wu
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@@gmail.com
B. Device:
Proprietary Name: Surgical Face Mask (L 17595mm) Common Name: Surgical Face Mask Model(s): L 17595mm
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
4
C. Primary Predicate Device:
| 510K | Device name | ASTM F2100-19
level | Manufacturer |
|---------|-------------------|------------------------|-------------------------------------|
| K221272 | Medical Face Mask | Level 2 &3 | Shandong Xingyu Gloves Co.,
Ltd. |
(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Indications use of the device:
The Surgical Face Mask is 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.
E. Device Description:
The Proposed device(s) are blue 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 device(s) are manufactured with three layers, the inner and outer layers are made of nonwoven fabric (polypropylene), and the middle layer is made of melt blown fabric (polypropylene). 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 and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene .iron and zinc. The proposed device(s) are sold nonsterile and are intended to be single use, disposable device.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate device | Comparison |
|---|---|---|---|
| Manufacturer | Henan Chaoya Medical Equipment | ||
| Co., Ltd. | Shandong Xingyu Gloves Co., | ||
| Ltd. | - | ||
| 510K number | K230617 | K221272 | - |
| Classification | Class II Device, | ||
| FXX (21CFR878.4040) | Class II Device, | ||
| FXX (21CFR878.4040) | Same |
5
| Indications for use | | | The Surgical Face Mask is
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 Medical Face Mask is
intended to be worn to protect
both the patient and healthcare
personnel from transfer of
microorganisms, body fluids and
particulate material. The
Disposable Medical 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(s), provided
non-sterile. | Same |
|-----------------------|----------|-----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| | Material | Outer
layer | Non-woven fabric(polypropylene) | Non-woven fabric | Same |
| | | Middle
layer | Melt blown fabric (polypropylene) | Melt-blown Non-woven fabric | Same |
| | | Inner
layer | Non-woven fabric (polypropylene) | Non-woven fabric | Same |
| | | Nose
clip | Polypropylene ,iron and zinc | Metal Core Plastic
(Iron wire & Polypropylene) | Different |
| | | Ear
loops | Polyester and Spandex | Polyester and Spandex | Same |
| Color | | | Blue | Blue, Black | Same |
| Dimension
(length) | | | $175mm ±8mm$ | $175mm+/-5mm$ | Similar |
| Dimension
(Width) | | | $95mm±4mm$ | $95mm+/-5mm$ | Similar |
| OTC use | | | Yes | Yes | Same |
| Sterility | | | Non-Sterile | Non-Sterile | Same |
| Use | | | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM F2100-19 | | | Level 2 | Level 2 & 3 | Same |
6
| level | |||
|---|---|---|---|
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
From the comparison we found the material of proposed device's nose clip was different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. 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 Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004:
- A 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 A And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed VolumeAt A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
- A ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand 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 clothingtextiles; A
Table 2 - Performance Testing
7
| Item | Purpose | Proposed device | Acceptance
Criteria | Result |
|-----------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|--------|
| Fluid Resistance
Performance
ASTM F1862 | Assess the
performance of a
mask to resistance
to a synthetic blood
preparation targeted
toward the mask at
a set pressure | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
32 out of 32 pass
at 120 mmHg | 29 out of 32 pass
at 120 mmHg for
level 2 | PASS |
| Particulate
Filtration
Efficiency ASTM
F2299 | Assess the
performance of
a mask to
penetration by
sub-micron
polystyrene
latex particles of
0.1 micron | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1: 98.21%
Lot2: 98.21%
Lot3: 98.16% | ≥ 98% | PASS |
| Bacterial
Filtration
Efficiency ASTM
F2101 | Assess the
performance of
a mask to
penetration by a
prepared solution
with known
concentration of
an indicator
bacterial organism | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1: 98.21%
Lot2: 98.24%
Lot3: 98.20% | ≥ 98% | PASS |
| Differential
Pressure (Delta P)
EN 14683 Annex
C | Assess the
performance of
a mask for
resistance to
air movement
through the
materials of the
face of the mask | 3 non-consecutive
lots tested, using a
sample size of
32/lot.
Lot1:2.52
mmH2O/cm²
Lot2: 2.60
mmH2O/cm²
Lot3: 2.60 |