(343 days)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
The surgical 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 non-sterile and are intended to be single use, disposable devices.
The provided text describes the acceptance criteria and the results of non-clinical tests for a surgical mask (K202746). It explicitly states that no clinical study was implemented.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
| Items | Acceptance Criteria (Level 2, ASTM F2100-19) | Reported Device Performance (Result) |
|---|---|---|
| Bacterial filtration efficiency (BFE) (%) | ≥98 | 99.8~99.9% |
| Differential pressure (mmH2O/cm²) | <6.0 mmH2O/cm² | 4.0~4.4 mmH2O/cm² |
| Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE) | ≥98 | 99.68~99.83% |
| Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result | 29 of 32 test articles passed at 120mmHg | 32 of 32 test articles passed at 120mmHg |
| Flame spread | Class 1 | Class 1, Non Flammable |
| Cytotoxicity | Comply with ISO 10993-5 (non-cytotoxic) | Noncytotoxic |
| Irritation | Comply with ISO 10993-10 (non-irritating) | Nonirritating |
| Sensitization | Comply with ISO 10993-10 (non-sensitizing) | Nonsensitizing |
2. Sample size used for the test set and the data provenance
- Sample Size for Synthetic Blood Resistance: 32 test articles (masks).
- Data Provenance: The document doesn't explicitly state the country of origin or whether the tests were retrospective or prospective, but it refers to recognized standards (ASTM F2100-19, ISO 10993-5, ISO 10993-10). These are likely laboratory tests conducted to specific protocols.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The tests are non-clinical, laboratory-based performance and biocompatibility tests against established standards, not expert-adjudicated clinical outcomes.
4. Adjudication method for the test set
- Not applicable. This is not a study requiring human adjudication of results. The acceptance criteria are objective measurements against defined metrics.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This is a medical device (surgical mask), not an AI-assisted diagnostic tool. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a surgical mask, not an algorithm.
7. The type of ground truth used
- Objective Performance Standards: The ground truth is established by recognized international and national standards for medical face masks and biocompatibility, specifically:
- ASTM F2100-19 Standard Specification for Performance of Materials Used in Medical Face Masks
- ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10:2010 Biological Evaluation of Medical Device - Part 10: Stimulation and allergic reaction
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not a machine learning model.
9. How the ground truth for the training set was established
- Not applicable. As above, there is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
August 27, 2021
Ningbo Jingeao Electronics Inc. % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K202746
Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 8, 2021 Received: July 26, 2021
Dear Boyle Wang:
We have reviewed vour 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
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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,
Liqun Zhao -S
For Clarence W. Murray III, Ph.D. 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
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Indications for Use
510(k) Number (if known) K202746
Device Name
Surgical mask
Indications for Use (Describe)
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
| 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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510(k) Summary
510(k) number: K202746
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 21 CFR 807.92.
1.0 Submitter's information
Name: Ningbo Jingeao Electronics Inc. Address: No.2 Jinyuan Road, Longshan Industrial zone, Cixi City, Zhejiang Province, 315311, China Phone Number: 86-18800333393 Fax number: 86-574-63973722 Contact: Ms. Yiyun Yu Date of Preparation: Auq.23, 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: Surgical mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): Ear loop, 175×95mm
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surqical apparel
4.0 Predicate device information
Manufacturer: Wuhan Dymex Healthcare Co., Ltd Surqical Face Mask Device: 510(k) number: K182515
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5.0 Intended Use
The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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.
6.0 Device description
The surgical 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 non-sterile and are intended to be single use, disposable devices.
| Table 1 - General Comparison | |||
|---|---|---|---|
| Item | Proposed device | Predicated device | Remark |
| Product Code | FXX | FXX | Identical |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Identical |
| Class | II | II | Identical |
| Product name | Surgical mask | Surgical Face Mask | - |
| 510(k) No. | K202746 | K182515 | - |
| Models | Ear loop, 175×95mm | Ear loop | - |
| Indications for Use | The surgical mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. It 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. | 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. | Identical |
| OTC use | Yes | Yes | Identical |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | Identical |
| Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Identical |
7.0 Technological Characteristic Comparison Table
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| External layer | Spun-bond polypropylene | Spun-bond polypropylene | Identical | |
|---|---|---|---|---|
| Material | Nose piece | Galvanized iron wire | Malleable polyethylenewire | * Gap 1 |
| Material | Ear loop | Polyester, spandex | spandex | * Gap 2 |
| Material | Color | Blue | Yellow | * Gap 3 |
| Material | Dimension (Length) | $17.5cm\pm0.5cm$ | $17.5cm\pm0.2cm$ | * Gap 4 |
| Material | Dimension (Width) | $9.5cm\pm0.5cm$ | $9.5cm\pm0.2cm$ | * Gap 5 |
| Sterility | Non-Sterile | Non-Sterile | Identical | |
| Single Use | Yes | Yes | Identical | |
| Sterile | No | No | Identical | |
| ASTM F2100 Level | Level 2 | Level 2 | Identical | |
| Material | Cytotoxicity | Comply with ISO 10993-5 | Comply with ISO 10993-5 | Identical |
| Material | Irritation | Comply with ISO 10993-10 | Comply with ISO 10993-10 | Identical |
| Material | Sensitization | Comply with ISO 10993-10 | Comply with ISO 10993-10 | Identical |
- Gap analysis:
Gap 1-3: the two devices have some difference in materials and product color, product materials safety is proved by its biocompatibility, and the difference does not raise additional questions for safety and effectiveness of device.
Gap 4-5: the two devices share same dimensions otherwise the tolerance is different, the little deviation in tolerance does not raise additional questions for safety and effectiveness of device.
8.0 Non-Clinical Test Conclusion
The proposed device was tested and conformed to the related recognized 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.
| Items | Performance | Acceptance Criteria(Level 2, ASTMF2100-19*1) | Result |
|---|---|---|---|
| Bacterial filtrationefficiency (BFE) (%) | 99.8~99.9% | ≥98 | Pass |
| Different pressure(mmH2O/cm²) | 4.0~4.4 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micron particulatefiltration efficiency at 0.1micron, % (PFE) | 99.68~99.83% | ≥98 | Pass |
| Resistance to penetrationby synthetic blood,Minimum pressure inmmHg for pass result | 32 of 32 test articlespassed at 120mmHg | 29 of 32 test articlespassed at 120mmHg | Pass |
| Flame spread | Class 1, Non Flammable | Class 1 | Pass |
Table 2 - Performance Testing
*1: ASTM F2100-19 Standard Specification for Performance of Materials Used in
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Medical Face Masks
| Item | Result | Conclusion |
|---|---|---|
| Cytotoxicity*2 | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation*3 | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization*3 | Under the conditions of the study, the device is nonsensitizing | Pass |
Table 3 - Biocompatibility Testing
*2: the Cytotoxicity test follows standard of ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
*3: the Irritation and Sensitization test follows standard of ISO 10993-10:2010 Biological Evaluation of Medical Device-Part 10:stimulation and allergic reaction
8.0 Clinical Test Conclusion
No clinical study implemented for the Surgical mask.
10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K202746, the Surgical mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K182515.
§ 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.