(34 days)
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 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.
This document describes non-clinical performance and biocompatibility testing for the D-Care Surgical Face Mask 3 Ply and D-Care Medical Face Mask 3 Ply.
Here's the requested information:
1. A table of acceptance criteria and the reported device performance
| Performance Characteristic | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Fluid Resistance | ≥29 out of 32 passed in 160 mmHg (Level 3) | ≥29 out of 32 passed in 160 mmHg (Level 3) |
| Particulate Filtration | ≥98% at 0.1µm | ≥99% at 0.1µm |
| Bacterial Filtration | ≥98% | ≥99% |
| Differential Pressure | < 6.0 mm H2O/cm² | < 4 mmH2O/cm² |
| Flammability | Class 1 (≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) |
| Cytotoxicity | The device is non-cytotoxic | Under the conditions of the studies, the device is non-cytotoxic |
| Skin Sensitization | The device is non-sensitizing | Under the conditions of the studies, the subject device is non-sensitizing |
| Skin Irritation | The device is non-irritating | Under the conditions of the studies, the device is non-irritating |
2. Sample size used for the test set and the data provenance
- Fluid Resistance (ASTM F1862): At least 32 samples (implied from "≥29 out of 32 passed").
- Other Performance Characteristics (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The document states that performance testing was performed on "three non-consecutive lots" and that the "Sample size of each lot is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%." The exact sample size per lot per test is not explicitly stated, but it follows the ISO 2859-1 standard.
- Biocompatibility (Cytotoxicity, Skin Sensitization, Skin Irritation): The sample size for biocompatibility testing is not explicitly stated in this document.
- Data Provenance: The tests were conducted by the manufacturer, DANAMECO MEDICAL JOINT STOCK CORPORATION, based in Vietnam. The studies are non-clinical, likely laboratory-based. The document does not specify if the studies were retrospective or prospective, but given they are manufacturing tests for a new device, they are inherently prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes performance characteristics and biocompatibility testing for a medical device (surgical face mask). The "ground truth" in this context is established by adherence to recognized international standards (e.g., ASTM, ISO, CFR) and regulatory requirements, not through expert consensus on medical images or clinical outcomes. Therefore, the concept of "experts establishing ground truth" as understood in imaging or clinical studies does not directly apply here. The results are objective measurements from laboratory tests.
4. Adjudication method for the test set
Not applicable. The tests are objective measurements based on specified testing standards and acceptance criteria. There is no subjective interpretation requiring an adjudication method.
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
Not applicable. This is not an AI-based device, nor a diagnostic device that would typically involve human readers. It is a surgical face mask evaluated for its physical and biological performance characteristics.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable, as this is not an AI/algorithm-based device.
7. The type of ground truth used
The ground truth is established by:
- Objective measurement against recognized industry standards: ASTM F1862, ASTM F2299, ASTM F2101-19, 16 CFR 1610, ISO 10993-5, ISO 10993-10.
- Pre-defined acceptance criteria: These criteria are derived from regulatory guidance and standards (e.g., FDA recommendations, ASTM F2100 at level 3 for surgical masks).
8. The sample size for the training set
Not applicable, as this device does not involve machine learning or AI models with a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
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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.
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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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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 |
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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.
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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 | Notapplicable | |
| Applicant | DANAMECO MEDICALJOINT STOCKCORPORATION | ZHEJIANG HONGYUMEDICALI COMMODITYCO., LTD | Notapplicable | |
| ProductName | D-Care Surgical Face Mask3 Ply, D-Care Medical FaceMask 3 Ply | Surgical Face mask | Notapplicable | |
| Modelnumber | KTY3PLYKV/KTY3PLYVT | Ear loops | Notapplicable | |
| Device class | Class II Device, FXX(21 CFR 878.4040) | Class II Device, FXX(21 CFR 878.4040) | Same | |
| Indicationsfor Use | The D-Care Surgical FaceMask 3 Ply, D-Care MedicalFace Mask 3 Ply areintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. The surgical facemasks are intended for usein infection control practicesto reduce the potentialexposure to blood and bodyfluids. These are single use,disposable devices, providednon-sterile. | The Surgical Face Mask isintended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids and particulatematerial. This face mask isintended for use in infectioncontrol practices to reducethe potential exposure toblood and body fluids. Thisis single use, disposabledevice, 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 withpolypropylene resin | Different | |
| DesignFeatures | Ear loops: 80% polyester20% spandex | Ear loops: polyester +spandex | Similar | |
| Mask Style | Flat Pleated | Flat Pleated | Same | |
| Color | Blue | Blue | Same | |
| SpecificationandDimension | Length: 17.5cm±0.5cmWidth: 9.5cm±0.5cm | Length: 17.5cm±0.2cmWidth: 9.5cm±0.2cm | Similar | |
| Dimensionear 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 | ||||
| FluidResistancePerformanceASTMF1862 | Pass at 160 mmHg(Level 3 Fluid Resistance) | Pass at 160 mmHg(Level 3 Fluid Resistance) | Same | |
| ParticulateFiltrationEfficiencyASTMF2299 | ≥99% at 0.1µm | ≥99% at 0.1µm | Same | |
| BacterialFiltrationEfficiencyASTMF2101-19 | ≥99% | ≥99% | Same | |
| DifferentialPressure(Delta P) | < 4 mmH2O/cm² | < 4 mmH2O/cm² | Same | |
| Flammability16 CFR1610 | Class 1 | Class 1 | Same | |
| Biocompatibility | ||||
| CytotoxicityISO 10993-5 | Under the conditions of thestudies, the subject device isnon-cytotoxic | Under the conditions of thestudy, the device extractwas determined to be non-cytotoxic | Same | |
| IrritationISO 10993-10 | Under the conditions of thestudies, the subject device isnon-irritating | Under the conditions of thestudy, the device extractwas determined to be non-irritant | Same | |
| SensitizationISO 10993-10 | Under the conditions of thestudies, the subject device isnon-sensitizing | Under the conditions of thestudy, the device extractwas determined to be non-sensitizer | Same |
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The subject device is same indication for use, design feature, design style, component of material (except nose piece), performance characteristics and biocompatibility with predicate device, similar dimension of size in comparison with predicate device. The component of ear loop of subject device is similar with predicate device but clearly claim the percent of composition.
The subject device is different material of nose piece to predicate device. The subject device which was included the nose piece had been tested and the result was complied with acceptance criteria.
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(7) Summary of Non-clinical test
| Performance characteristics | ||||||
|---|---|---|---|---|---|---|
| Test Method | Subject Device | Acceptance Criteria | Conclusion | |||
| Fluid ResistancePerformanceASTM F1862 | ≥29 out of 32 passed in160 mmHg(Level 3) | 29 out of 32 passed in160 mmHg(Level 3) | Pass | |||
| Particulate FiltrationEfficiencyASTM F2299 | ≥99% at 0.1µm | ≥98% at 0.1µm | Pass | |||
| Bacterial FiltrationEfficiencyASTM F2101-19 | ≥99% | ≥98% | Pass | |||
| DifferentialPressure (Delta P) | < 4 mmH2O/cm² | < 6.0 mm H2O/cm² | Pass | |||
| Flammability16 CFR 1610 | Class 1(≥ 3.5 seconds) | Class 1 (≥ 3.5 seconds) | Pass |
Performance testing were performed on three non-consecutive lots to support that the performance specification are maintained cross production lots and the lot-to-lot variability in performance is acceptable.
Sample size of each lot is complied with ISO 2859-1, general inspection level II as FDA recommendation and acceptance quality limit (AQL) of 4%.
The results of performance testing of subject device demonstrate that the subject device met all design specification as was same to predicate device, complied with requirements in guidance: "Surgical Masks – Premarket Notification [510(k)] Submissions", complied with standard ASTM F2100 at level 3.
| Biocompatibility | ||||
|---|---|---|---|---|
| Standard | Subject Device | AcceptanceCriteria | Conclusion | |
| CytotoxicityISO 10993-5 | Under the conditions of the studies,the device is non-cytotoxic. | The device isnon-cytotoxic | Pass |
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| SkinSensitizationtest ISO10993-10 | Under the conditions of the studies,the subject device is non-sensitizing | The device isnon-sensitizing | Pass |
|---|---|---|---|
| Skin Irritationtest ISO10993-10 | Under the conditions of the studies,the device is non-irritating. | The device isnon-irritating | Pass |
The biocompatibility evaluation of this subject device was conducted according to ISO 10993-1: nature of body contact of the subject device is belonged to category Surface device, intact skin, with contact duration A-limited (≤24h)
The subject device was evaluated in its final finished form, in blue color.
The results of biocompatibility testing of subject device demonstrate that the subject device is biocompatible and safe for its intended use.
(8) Summary of Clinical test
No clinical study is included in this submission.
(9) Conclusion
The conclusions drawn from the nonclinical tests demonstrate that the proposed subject device is as safe, as effective, and performs as well as or better than the legally marketed predicate device.
§ 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.