(34 days)
Not Found
No
The device description and performance studies focus solely on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended for infection control to reduce exposure to microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
Explanation: The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is a barrier device and does not perform any diagnostic function.
No
The device description clearly outlines physical components made of nonwoven polypropylene materials, ear loops, and a nose piece, indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are 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 samples taken from the body.
- Device Description: The description details the physical construction of the mask (layers of nonwoven material, ear loops, nose piece). This is consistent with a physical barrier device, not a diagnostic instrument or reagent.
- 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 relevant to a protective device, not a diagnostic test's accuracy or precision.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or screening purposes. This surgical face mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.
Product codes
FXX
Device Description
The subject device is three-layers, flat-pleated masks constructed of nonwoven polypropylene materials, the inner and outer layers are made of polypropylene nonwoven, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A polypropylene wire nose piece is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable devices, provided non-sterile.
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 tests were performed.
Fluid Resistance Performance ASTM F1862: ≥29 out of 32 passed in 160 mmHg (Level 3), Acceptance Criteria: 29 out of 32 passed in 160 mmHg (Level 3), Conclusion: Pass.
Particulate Filtration Efficiency ASTM F2299: ≥99% at 0.1µm, Acceptance Criteria: ≥98% at 0.1µm, Conclusion: Pass.
Bacterial Filtration Efficiency ASTM F2101-19: ≥99%, Acceptance Criteria: ≥98%, Conclusion: Pass.
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.
January 23, 2022
Danameco Medical Joint Stock Corporation Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K213970
Trade/Device Name: D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 18, 2021 Received: December 20, 2021
Dear Prithul Bom:
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.
1
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 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.
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 Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213970
Device Name
D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply
Indications for Use (Describe)
The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.
Type of Use (Select one or both, as applicable)
| Registration for Non-STP CMA Sales Only | Registration for Non-STP CMA Sales & STP CMA Sales |
|---|---|
| ------------------------------------------------------------------ | ---------------------------------------------------------------------------------------- |
| | 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 K213970
This 510(k) Summary as per 21 CFR 807.92
Date of submission: January 21, 2022
(1) Applicant information
| 510(k) Owner/ Applicant: | DANAMECO MEDICAL JOINT STOCK CORPORATION |
|---|---|
| Address: | Head office: |
| DANAMECO MEDICAL JOINT STOCK CORPORATION | |
| No 12, Trinh Cong Son Street, Hoa Cuong Nam, | |
| Hai Chau District, 550000, Da Nang City, Viet Nam | |
| Factory: | |
| Quang Nam Medical Device Factory- Brand of Danameco | |
| Medical Joint Stock Corporation | |
| Trang Nhat 2 Industrial Zone, Dien Hoa Commune, Dien | |
| Ban Town, 560000 Quang Nam Province, Viet Nam. | |
| Contact: | Huynh Thi Li Li (Ms.) |
| Email: | info@danameco.com; |
| qa@danameco.com | |
| Phone: | (+84)-236-3849833 |
| Owner/Operator Number: | 10071934 |
| FEI Number: | 3016970619 |
| US Agent: | Emergo Global Representation LLC at address: 2500 |
| Bee Cave Road, Building 1, Suite 300, Austin, | |
| TX US 78746 | |
| Contact of US agent: | Michael van der Woude, Phone: 512 3279997, |
| Email: USAgent@UL.com | |
| Correspondent: | Regulatory Technology Services at address: 1000 |
| Westgate Drive, Suite #510, Saint Paul, Minnesota, 55114 | |
| Contact of Correspondent: Ms. Prithul Bom - Accredited Person, Reviewer |
4
Phone 612-963-0379 Email: prithul.bom@rts3pro.com
(2) Subject device
| Trade name: | D-Care Surgical Face Mask 3 Ply, |
|---|---|
| D-Care Medical Face Mask 3 Ply | |
| Model number: | KTY3PLYKV/KTY3PLYVT |
| Common Name: | Surgical Face Mask |
| Classification Name: | Masks, Surgical |
| Review Panel: | General Hospital |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(3) Predicate device
| Submitter: | Zhejiang Hongyu Medicali Commodity Co.,Ltd |
|---|---|
| Device name: | Surgical Face Mask |
| 510(k) number: | K211897 |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(4) Description of device
The subject device is three-layers, flat-pleated masks constructed of nonwoven polypropylene materials, the inner and outer layers are made of polypropylene nonwoven, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A polypropylene wire nose piece is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
5
This subject device is provided with size 17.5 cm ± 0.5 cm. The subject device is single-use, disposable devices, provided non-sterile.
(5) Indications for use
The D-Care Surgical Face Mask 3 Ply, D-Care Medical Face Mask 3 Ply are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. These are single use, disposable devices, provided non-sterile.
(6) Comparison of Technological Characteristics and Performance testing withthe Predicate device
| Item | Subject Device | Predicate Device | Comparison | |
|---|---|---|---|---|
| 510 (k) | ||||
| number | - | K211897 | Not | |
| applicable | ||||
| Applicant | DANAMECO MEDICAL | |||
| JOINT STOCK | ||||
| CORPORATION | ZHEJIANG HONGYU | |||
| MEDICALI COMMODITY | ||||
| CO., LTD | Not | |||
| applicable | ||||
| Product | ||||
| Name | D-Care Surgical Face Mask | |||
| 3 Ply, D-Care Medical Face | ||||
| Mask 3 Ply | Surgical Face mask | Not | ||
| applicable | ||||
| Model | ||||
| number | KTY3PLYKV/KTY3PLYVT | Ear loops | Not | |
| applicable | ||||
| Device class | Class II Device, FXX | |||
| (21 CFR 878.4040) | Class II Device, FXX | |||
| (21 CFR 878.4040) | Same | |||
| Indications | ||||
| for Use | The D-Care Surgical Face | |||
| Mask 3 Ply, D-Care Medical | ||||
| Face Mask 3 Ply are | ||||
| intended to be worn to | ||||
| protect both the patient and | ||||
| healthcare personnel from | ||||
| transfer of microorganisms, | ||||
| body fluids and particulate | ||||
| material. The surgical face | ||||
| masks are intended for use | ||||
| in infection control practices | ||||
| to reduce the potential | ||||
| exposure to blood and body | ||||
| fluids. These are single use, | ||||
| disposable devices, provided | ||||
| non-sterile. | 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. This face mask is | ||||
| intended for use in infection | ||||
| control practices to reduce | ||||
| the potential exposure to | ||||
| blood and body fluids. This | ||||
| is single use, disposable | ||||
| device, provided non-sterile. | Same | |||
| Material | ||||
| Outer layer | Polypropylene non-woven | Spunbond polypropylene | Same | |
| Middle layer | Polypropylene meltblown | Meltblown polypropylene | Same | |
| Inner layer | Polypropylene non-woven | Spunbond polypropylene | Same | |
| Nose piece | Polypropylene | lron core coated with | ||
| polypropylene resin | Different | |||
| Design | ||||
| Features | Ear loops: 80% polyester | |||
| 20% spandex | Ear loops: polyester + | |||
| spandex | Similar | |||
| Mask Style | Flat Pleated | Flat Pleated | Same | |
| Color | Blue | Blue | Same | |
| Specification | ||||
| and | ||||
| Dimension | Length: 17.5cm±0.5cm | |||
| Width: 9.5cm±0.5cm | Length: 17.5cm±0.2cm | |||
| Width: 9.5cm±0.2cm | Similar | |||
| Dimension | ||||
| ear loops | 17cm±0.5cm | 17cm±0.2cm | Similar | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| Performance Characteristics | ||||
| Fluid | ||||
| Resistance | ||||
| Performance | ||||
| ASTM | ||||
| F1862 | Pass at 160 mmHg | |||
| (Level 3 Fluid Resistance) | Pass at 160 mmHg | |||
| (Level 3 Fluid Resistance) | Same | |||
| Particulate | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM | ||||
| F2299 | ≥99% at 0.1µm | ≥99% at 0.1µm | Same | |
| Bacterial | ||||
| Filtration | ||||
| Efficiency | ||||
| ASTM | ||||
| F2101-19 | ≥99% | ≥99% | Same | |
| Differential | ||||
| Pressure | ||||
| (Delta P) |