(86 days)
Not Found
No
The description focuses on the physical construction and performance characteristics of a surgical mask, with no mention of AI or ML technologies.
No.
The primary purpose of the device is to protect the user and others from the transfer of microorganisms and particulate material, not to treat a disease or condition.
No
The device, a surgical mask, is intended to protect from transfer of microorganisms, body fluids, and particulate material, not to diagnose medical conditions.
No
The device description clearly outlines a physical, multi-layer mask with ear loops and a nose piece, indicating it is a hardware medical 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. This is a physical barrier function, not a diagnostic test performed on a sample taken from the body.
- Device Description: The description details the physical construction of the mask (layers, ear loops, nose piece). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring specific substances (analytes)
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
- Performance Studies: The performance studies focus on the physical and filtration properties of the mask (BFE, PFE, fluid resistance, flammability), which are relevant to its barrier function, not diagnostic accuracy.
- Predicate Device: The predicate device is a "Surgical mask," which is also a physical barrier device, not an IVD.
In summary, the device is a medical mask intended for infection control through physical protection, not for performing diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
Medical 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 as sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as 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)
The proposed device was tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Medical face masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance Testing:
Fluid Resistance Performance ASTM F1862: Pass - Lot 1# 31 Out of 32 pass at 160mmHg (21.3 kPa); Lot 2# 31 Out of 32 pass at 160mmHg (21.3 kPa); Lot 3# 32 Out of 32 pass at 160mmHg (21.3 kPa)
Particulate Filtration Efficiency ASTM F2299: Pass - Lot1#99.02%-99.58%; Lot2#99.05%-99.59%; Lot3#99.10%-99.68%
Bacterial Filtration Efficiency ASTM F2101: Pass - Lot1#98.8%-99.7%; Lot2#98.7%-99.5%; Lot3#98.9%-99.5%
Differential Pressure (Delta P) MIL-M-36954C: Pass - Lot1#1.66-4.44mmH20/cm²; Lot2#1.63-4.24mmH20/cm²; Lot3#1.60-4.43mmH20/cm2
Flammability 16 CFR 1610: Pass, Class 1
Biocompatibility Testing:
Cytotoxicity: Pass - Under the conditions of the study, the subject device was non-cytotoxic.
Irritation: Pass - Under the conditions of the study, the subject device was non-irritating.
Sensitization: Pass - Under the conditions of the study, the subject device was non-sensitizing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency (BFE) (%):
Lot 1# 31 Out of 32 pass at 160mmHg (21.3 kPa);
Lot 2# 31 Out of 32 pass at 160mmHg (21.3 kPa);
Lot 3# 32 Out of 32 pass at 160mmHg (21.3 kPa).
Different pressure (mmH2O/cm²):
Lot1#99.02%-99.58%;
Lot2#99.05%-99.59%;
Lot3#99.10%-99.68%.
Sub-micron particulate filtration efficiency at 0.1 micron, % (PFE):
Lot1#98.8%-99.7%;
Lot2#98.7%-99.5%;
Lot3#98.9%-99.5%.
Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result:
Lot1#1.66-4.44mmH20/cm²
Lot2#1.63-4.24mmH20/cm²
Lot3#1.60-4.43mmH20/cm2
Flame spread:
Lot 1# Class I;
Lot 2# Class I;
Lot 3# Class I
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). 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.
February 20, 2022
Hunan Zhenheyikang Medical Instrument Co., Ltd % Boyle Wang Official Correspondent Shanghai Truthful Information Technology Co., Ltd. RM.1801,No.161 Lujiazui East Rd.,Pudong Shanghai, Shanghai 200120 China
Re: K213724
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 10, 2022 Received: February 16, 2022
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,
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) K213724
Device Name Medical Surgical Mask
Indications for Use (Describe)
Medical 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 as 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 K213724
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 submitter's Information
Name: HUNAN ZHENHEYIKANG MEDICAL INSTRUMENT CO., LTD
Address: No.6 Building Jingxiang Energy,No.55 Xiaguang East Road,Gaoxin District, Xiangtan, Hunan, China
Tel:+86-0731-58262222
Contact: Yilin Yin
Date of Preparation: Nov.12, 2021
Designated Submission Correspondent
Mr. Boyle Wang
Shanghai Truthful Information Technology Co., Ltd.
Room 1801, No. 161 East Lujiazui Rd., Pudong,Shanghai 200120 ,China Tel: +86-21-50313932
Email: Info@truthful.com.cn
2.0 Device Information
Trade name: Medical Surqical Mask Common name: Surgical Face Mask Classification name: Surgical Face Mask Model: Ear-loop Type
4
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II
Panel: Surgical Apparel
4.0 Predicate Device Information
Manufacturer: Jiangsu Xingtong Biotechnology Group Co., Ltd. Device: Surgical mask
510(k) number: K211454
5.0 Device Description
The Medical Surgical Mask is single use, three-layer, flat-pleated style with ear loops and nose piece. The Medical Surgical Mask is manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of melt blown polypropylene filter. 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 lavers of facemask is to allow the user to fit the facemask around their nose. which is made of Galvanized iron wire. The Medical Surgical Mask will be provided in blue. The Medical Surgical Mask is sold as sterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
The Medical Surgical 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 as sterile.
7.0 Technological Characteristic Comparison
5
| Item | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| K213724 | K211454 | |||
| Product Name | Medical Surgical Mask | Surgical 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 | Medical 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), | The surgical 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, | Same | |
| provided as sterile. | ||||
| disposable device, | ||||
| provided as sterile. | ||||
| Design features | Ear Loops, | |||
| 3 layers | Ear loops: XT10A1; Tie-on: XT10B1; | |||
| 3 layers | Different | |||
| Analysis 1 | ||||
| Mask Styles | Flat pleated | Flat pleated | Same | |
| Material | Outer | |||
| facing | ||||
| layer | Polypropylene | Polypropylene | Same | |
| Middle | ||||
| layer | Melt-blown cloth | |||
| (polypropylene) | Melt-blown cloth | |||
| (polypropylene) | Same | |||
| Inner | ||||
| Facing | ||||
| layer | Polypropylene | Polypropylene | Same | |
| Nose | ||||
| piece | Galvanized iron wire | Polyethylene coated | ||
| steel wire | Different | |||
| Analysis 1 | ||||
| Ear | ||||
| loops | 78% Polyester + 22% | |||
| spandex | -Ear loops: Polyester silk & | |||
| Polyurethane filament | Similar | |||
| Analysis 1 | ||||
| Color | Blue | Blue | Same | |
| Dimension | 175mm×95mm±5% | Mask body for ear-loop | ||
| type: 17.5cm×9.5cm & | ||||
| 14.5cm×9.5cm | ||||
| Mask body for Tie-on type: | ||||
| 17.5cm×9.5cm | Similar | |||
| Analysis2 | ||||
| OTC use | Yes | Yes | Same | |
| Shelf life | 2 years | 2 years | Same | |
| Single Use | Yes | Yes | Same | |
| Sterility | Sterile | Sterile | Same | |
| Sterilization | ||||
| method and | ||||
| S.A.L. | Sterilized by ethylene oxide | |||
| gas, SAL=10-6 | Sterilized by ethylene oxide | |||
| gas, SAL=10-6 | Same | |||
| ASTM F2100 Level | Level 3 | Level 3 | Same | |
| Bacterial filtration | ||||
| efficiency (BFE) (%) | Lot 1# 31 Out of 32 pass at | |||
| 160mmHg (21.3 kPa); | ||||
| Lot 2# 31 Out of 32 pass at | ||||
| 160mmHg (21.3 kPa); | ||||
| Lot 3# 32 Out of 32 pass at | ||||
| 160mmHg (21.3 kPa). | Lot 1# pass at 160mmHg; | |||
| Lot 2# pass at 160mmHg; | ||||
| Lot 3# pass at 160mmHg. | Similar | |||
| Different pressure | ||||
| (mmH2O/cm²) | Lot1#99.02%-99.58%; | |||
| Lot2#99.05%-99.59%; | ||||
| Lot3#99.10%-99.68%. | Lot 1# 99.7%-99.9%; | |||
| Lot 2# 99.7%-99.9%; | ||||
| Lot 3# 99.7%-99.9%. | Similar | |||
| Sub-micron particulate | ||||
| filtration efficiency at | ||||
| 0.1 micron, % (PFE) | Lot1#98.8%-99.7%; | |||
| Lot2#98.7%-99.5%; | ||||
| Lot3#98.9%-99.5%. | Lot 1# 99.2%-99.8%; | |||
| Lot 2# 99.0%-99.7%; | ||||
| Lot 3# 99.3%-99.7%. | Similar | |||
| Resistance to | ||||
| penetration by | ||||
| synthetic blood, | ||||
| Minimum pressure | ||||
| in mmHg for pass | ||||
| result | Lot1#1.66-4.44mmH20/cm² | |||
| Lot2#1.63-4.24mmH20/cm² | ||||
| Lot3#1.60-4.43mmH20/cm² | Lot 1# 2.3-4.6; | |||
| Lot 2# 2.3-4.5; | ||||
| Lot 3# 2.0-3.9 | Similar | |||
| Flame spread | Lot 1# Class I; | |||
| Lot 2# Class I; | ||||
| Lot 3# Class I | Lot 1# Class I; | |||
| Lot 2# Class I; | ||||
| Lot 3# Class I | Same | |||
| Item | Purpose | Acceptance | ||
| Criteria | Result | |||
| Fluid Resistance | ||||
| Performance ASTM | ||||
| F1862 | The purpose of the | |||
| methodology is to | ||||
| evaluate the Fluid | ||||
| Resistance | 29 Out of 32 pass at 120 | |||
| mmHg (21.3 kPa) | Pass | |||
| Lot 1# 31 Out of 32 pass | ||||
| at 160mmHg (21.3 kPa) | ||||
| Lot 2# 31 Out of 32 pass | ||||
| at 160mmHg (21.3 kPa) | ||||
| Lot 3# 32 Out of 32 pass | ||||
| at 160mmHg (21.3 kPa) | ||||
| Particulate | ||||
| Filtration Efficiency | ||||
| ASTM F2299 | The purpose of the | |||
| methodology is to | ||||
| evaluate the | ||||
| Particulate Filtration | ||||
| Efficiency | ≥ 98% | Pass | ||
| Lot1#99.02%-99.58%; | ||||
| Lot2#99.05%-99.59%; | ||||
| Lot3#99.10%-99.68% | ||||
| Bacterial Filtration | ||||
| Efficiency | ||||
| ASTM F2101 | The purpose of the | |||
| methodology is to | ||||
| evaluate the Bacterial | ||||
| Filtration Efficiency | ≥ 98% | Pass | ||
| Lot1#98.8%-99.7%; | ||||
| Lot2#98.7%-99.5%; | ||||
| Lot3#98.9%-99.5% | ||||
| Differential | ||||
| Pressure | ||||
| (Delta P) MILM- 36954C | The purpose of the | |||
| methodology is to | ||||
| evaluate the | ||||
| Differential Pressure | ||||
| (Delta P) |