(416 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard medical face mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the mask is for protection and reduction of exposure to microorganisms and fluids, not for treating any medical condition.
No
Explanation: The device is a face mask intended to protect against the transfer of microorganisms and fluids, not to diagnose a condition. Its performance studies focus on filtration efficiency and biocompatibility, not diagnostic capabilities.
No
The device description clearly outlines a physical, three-layer face mask made of nonwoven and melt-blown fabrics with ear loops and a nose piece. The performance studies focus on physical properties and material biocompatibility, not software functionality.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states the device is a "Disposable Medical Face Mask" intended to be worn on the mouth and nose to protect against the transfer of microorganisms, body fluids, and particulate material. It acts as a physical barrier.
- Lack of Testing on Samples: The device does not perform any tests on biological samples. Its function is purely protective and preventative.
- Performance Studies: The performance studies listed (Resistance penetration synthetic blood, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability, 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, the Disposable Medical Face Mask is a medical device, but it falls under the category of a protective barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable 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. 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 (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-Clinical Test Conclusion: The proposed device was tested and conformed to 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.
Performance Testing:
- Resistance penetration synthetic blood: to Determine synthetic byblood penetration resistance as specified in Test Method F1862. Acceptance Criteria: 29 Out of 32 pass at 120 mmHg. Result: Lot 1: 31 out of 32 pass at 120mmHg; Lot 2: 31 out of 32 pass at 120mmHg; Lot 3: 32 pass at 120mmHg. Pass.
- Particulate Filtration Efficiency ASTM F2299: Determine particulate filtration efficiency as directed in Test Method F2299. Acceptance Criteria: >= 98%. Result: Lot 1: average 99.23%; Lot 2: average 99.29%; Lot 3: average 99.29%. Pass.
- Bacterial Filtration Efficiency ASTM F2101: Determine the bacterial filtration efficiency as directed in Test Method ASTM F2101. Acceptance Criteria: >= 98%. Result: Lot 1: average 99.75%; Lot 2: average 99.79%; Lot 3: average 99.75%. Pass.
- Differential Pressure (Delta - P): Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex C. Acceptance Criteria: =3.5 s, IBE, or DNI). Result: Lot 1: Class 1; Lot 2: Class 1; Lot 3: Class 1. Pass.
Biocompatibility Testing:
- Cytotoxicity: Determine the effects on cells following ISO 10993-5. Acceptance Criteria: The test article should not have potential toxicity to L-929 in the MTT method. Result: Pass under the conditions of the study, the device is noncytotoxic.
- Irritation: Estimate the potential for contact sensitization following ISO 10993-10. Acceptance Criteria: The irritation response category in the rabbit should be negligible. Result: Pass under the conditions of the study, the device is nonirritating.
- Sensitization: Estimate the irritation potential of medical device following ISO 10993-10. Acceptance Criteria: The test article should not cause delayed dermal contact sensitization in the guinea pig. Result: Pass under the conditions of the study, the device is nonsensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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 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 and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
November 5, 2021
Zhejiang Senhong Medical&Instrument Co., Ltd. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.608, No.738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K202676
Trade/Device Name: Disposable Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 20, 2021 Received: October 5, 2021
Dear Boyle 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,
For 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) K202676
Device Name Disposable Medical Face Mask
Indications for Use (Describe)
The Disposable 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. 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) |
|---|
| ------------------------------------------------- |
| | 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 (K202676)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's Information
Name: Zhejiang Senhong Medical&Instrument Co., Ltd. Address: Floor 1-2, Building 2, No 889 North Huancheng Rd, Fu'xi Subdistrict, Deqing County, Huzhou, Zhejiang, 313200, China Tel: 86-18006712375 Contact: Eric Jian Date of Preparation: Nov.3,2021
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Device Information
| Trade name: | Disposable Medical Face Mask |
|---|---|
| Common name: | Surgical Face Mask Classification |
| name: | Surgical Face Mask |
3.0 Classification
| Production code: | FXX |
|---|---|
| Regulation number: | 21CFR 878.4040 |
| Classification: | Class II |
| Panel: | Surgical Apparel |
4.0 Predicate Device Information
| Manufacturer: | WUHAN DYMEX HEALTHCARE CO., LTD. |
|---|---|
| Device: | SURGICAL FACE MASK |
| 510(k) number: | K182515 |
4
5.0 Device Description
The Disposable Medical Face Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The mask is manufactured with three layers, the inner and outer layers are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask. The elastic ear loops are not made with natural rubber latex. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of galvanized iron wire. The disposable medical face mask will be provided in blue. The masks are sold nonsterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
The Disposable 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. 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.
| Item | Subject Device
K202676 | Predicate Device
K182515 | Remark |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| Product Name | Disposable Medical Face
Mask | Surgical Face Mask | -- |
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Intended Use&
Indications for use | The Disposable 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.
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 |
Table 1 General Comparison
7.0 Technological Characteristics Comparison to the Predicate Device
5
| Design features | ||||
|---|---|---|---|---|
| Mask Styles | Ear Loops, 3 layers | Ear Loops, 3 layers | Same | |
| Flat pleated | Flat pleated | Same | ||
| Material | Outer facing layer | Nonwoven fabrics | Spun-bond polypropylene | Same |
| Middle layer | Melt blown fabrics | Melt blown polypropylene filter | Same | |
| Inner Facing layer | Nonwoven fabrics | Spun-bond polypropylene | Same | |
| Nose piece | Galvanized iron wire | Malleable polyethylene wire | Different* | |
| Ear loops | not made with natural rubber latex | not made with natural rubber latex | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 17.5 cm +/- 1cm | 17.5 cm +/- 1cm | Same | |
| Dimension (Width) | 9.5 cm +/- 1cm | 9.5 cm +/- 1cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same |
*The difference in the materials does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation has been performed on the final finished device which includes all construction materials.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to 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.
Table 2 - Performance Testing
6
| Test
Methodology | Purpose | Acceptance
Criteria | Result |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Resistance
penetration
synthetic blood | to Determine synthetic
byblood penetration
resistance as specified
in Test
Method F1862 | 29 Out of 32 pass
at 120 mmHg | Lot 1:
31 out of 32 pass at
120mmHg
Lot 2:
31 out of 32 pass at
120mmHg
Lot 3:
32 pass at 120mmHg
Pass |
| Particulate
Filtration
Efficiency
ASTM F2299 | Determine particulate
filtration efficiency as
directed in Test Method
F2299. | ≥ 98% | Lot 1: average 99.23%
Lot 2: average 99.29%
Lot 3: average 99.29%
Pass |
| Bacterial
Filtration
Efficiency
ASTM F2101 | Determine the bacterial
filtration efficiency as
directed in Test Method
ASTM F2101. | ≥ 98% | Lot 1: average 99.75%
Lot 2: average 99.79%
Lot 3: average 99.75%
Pass |
| Differential
Pressure
(Delta - P) | Determine
breathing
resistance or differential
pressure as directed in
EN 14683:2019, Annex
C. |