(58 days)
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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 Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose. The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
The provided text describes the acceptance criteria and the study conducted for a Disposable Medical Face Mask (DF3-001) to verify its performance and safety.
1. Table of acceptance criteria and the reported device performance:
| Item | Purpose | Acceptance Criteria | Reported Device Performance | Result |
|---|---|---|---|---|
| Fluid Resistance ASTM F1862 | Assess the performance of a mask to resistance to a synthetic blood preparation targeted toward the mask at a set pressure | 29 out of 32 pass at 160 mmHg for level 3 | Lot1, Lot2, Lot3: 32 out of 32 pass at 160 mmHg (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Particulate Filtration Efficiency ASTM F2299 | Assess the performance of a mask to penetration by sub-micron polystyrene latex particles of 0.1 micron | ≥ 98% | Lot1: 99.35% Lot2: 99.46% Lot3: 98.69% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Bacterial Filtration Efficiency ASTM F2101 | Assess the performance of a mask to penetration by a prepared solution with known concentration of an indicator bacterial organism | ≥ 98% | Lot1: 99.88% Lot2: 99.87% Lot3: 99.88% (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Differential Pressure (Delta P) EN 14683 Annex C | Assess the performance of a mask for resistance to air movement through the materials of the face of the mask | < 6.0 mmH2O/cm² | Lot1: 4.13 mmH2O/cm² Lot2: 4.18 mmH2O/cm² Lot3: 4.24 mmH2O/cm² (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Flammability 16 CFR 1610 | Assess the resistance of a mask to ignition | Class I | Lot1, Lot2, Lot3: Class I (tested over 3 non-consecutive lots, using a sample size of 32 masks/lot) | PASS |
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASS: Under the conditions of the study, the device is non-cytotoxic. | PASS |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASS: Under the conditions of the study, the device is non-irritating. | PASS |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASS: Under the conditions of the study, the device is non-sensitizing. | PASS |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
For all performance tests (Fluid Resistance, Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, and Flammability), the sample size used was 32 units per lot, across 3 non-consecutive lots.
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. However, the document is a 510(k) submission to the US FDA from a Chinese applicant (Wellmed Dental Medical Supply Co., Ltd. in Shenzhen, China), suggesting the tests were likely conducted by or for the manufacturer in China or by a certified lab for regulatory submission purposes. These are non-clinical (laboratory) tests performed specifically for regulatory approval.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is a non-clinical, laboratory-based performance and biocompatibility study for a medical device (face mask). There is no "ground truth" in the clinical sense established by human experts like radiologists. The "ground truth" is determined by established scientific standards and test methods (e.g., ASTM, EN, ISO standards), with results measured by laboratory equipment and qualified personnel following those protocols. Therefore, the concept of "number of experts" and their "qualifications" for establishing ground truth as typically understood in AI/clinical studies does not apply here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a non-clinical, laboratory-based performance and biocompatibility study. Adjudication methods are typically relevant for human-interpreted data, such as medical images or clinical diagnoses.
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 a non-clinical study for a medical face mask. It does not involve human readers, AI, or clinical effectiveness studies in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a physical medical product (a face mask), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" in this context is defined by the objective, reproducible measurements against established performance standards and specifications outlined in the referenced international standards (e.g., ASTM F1862, ASTM F2299, ASTM F2101, EN 14683, 16 CFR 1610, ISO 10993). The acceptance criteria for each test (e.g., "$\geq$ 98%," "< 6.0mmH2O/cm²") numerically define the acceptable performance.
8. The sample size for the training set:
Not applicable. This is a physical medical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set for this type of device.
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November 4, 2022
Wellmed Dental Medical Supply Co., Ltd. % Jarvis Wu Consultant Shanghai SUNGO Management Consulting Co., Ltd. 14th Floor, 1500# Century Avenue Shanghai, Shanghai 200122 China
Re: K222697
Trade/Device Name: Disposable Medical Face Mask (DF3-001) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 7, 2022 Received: September 7, 2022
Dear Jarvis Wu:
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 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.
Katherine D. Kavlock -S
for
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222697
Device Name Disposable Medical Face Mask (DF3-001)
Indications for Use (Describe)
The Disposable Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The Disposable Medical 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)
| Research Use (Part 21 CFR 301 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 331 Subpart C) |
__ 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
Document Date Prepared:2022/8/25
A. Applicant:
Name: Wellmed Dental Medical Supply Co.,Ltd
Address: 301 Zhongxing Science and Technology Building.No.64.Xin'an 2nd Road, Baoan District,
Shenzhen, China.
Contact Person: Renxian Tang
Tel: +86 13603081892
- Mail: wellmed@hotmail.com
Submission Correspondent:
Primary contact: Mr. Jarvis Wu
Shanghai SUNGO Management Consulting Co., Ltd.
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-58817802
Email: haiyu.wang@sungoglobal.com
Secondary contact: Mr. Raymond Luo
14th floor, 1500# Century Ave., Shanghai 200122, China
Tel: +86-21-68828050
Email: fda.sungo@@gmail.com
B. Device:
Proprietary Name: Disposable Medical Face Mask (DF3-001) Common Name: Disposable Medical Face Mask
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
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C. Predicate device (Primary):
| 510K | Device name | ASTM F2100-19level | Manufacturer |
|---|---|---|---|
| K213806 | Disposable Medical FaceMask | Level 3 | XIANTAO ZHIBO NONWOVENPRODUCTS CO., LTD. |
(Note: Predicate device has NOT been subject to any Medical Device Recalls, including design-related recall.)
D. Indications use of the device:
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. The Disposable Medical Face Mask 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.
E. Device Description:
The Proposed device(s) are blue color, and pleated type mask, utilizing ear loops way for wearing, and they all has Nose clips design for fitting the face mask around the nose.
The proposed device(s) are manufactured with three layers, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene filter. The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the face mask. The elastic ear loops are made of Nylon and Spandex. The nose piece contained in the proposed device(s) is in the layers of face mask to allow the user to fit the face mask around their nose, which is made of polypropylene ,metal wire. The proposed device(s) are sold non-sterile and are intended to be single use, disposable device.
F. Comparison with predicate device
| Device | Predicate Device | Proposed device | Comparison |
|---|---|---|---|
| Manufacturer | XIANTAO ZHIBONONWOVEN PRODUCTS CO.,LTD. | Wellmed Dental Medical SupplyCo.,Ltd | - |
| 510K number | K213806 | - | |
| Classification | Class II Device, | Class II Device, | Same |
Table 1 General Comparison
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Wellmed Dental Medical Supply Co.,Ltd
301 Zhongxing Science and Technology Building,No.64,Xin'an 2nd Road, Baoan District, Shenzhen, China.
| FXX (21CFR878.4040) | FXX (21CFR878.4040) | |||
|---|---|---|---|---|
| Indications for use | The Disposable Medical FaceMask is intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material. | The Disposable Medical Face Maskis intended to be worn to protectboth the patient and healthcarepersonnel from transfer ofmicroorganisms, body fluids andparticulate material. | ||
| These face masks are intended foruse in infection control practicesto reduce the potential exposureto blood and body fluids. This isa single use, disposable device(s),provided non-sterile. | The Disposable Medical Face Mask is intended foruse in infection control practices toreduce the potential exposure toblood and body fluids.This is asingle use, disposable device(s),provided non-sterile. | Same | ||
| Material | Outerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middlelayer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Innerlayer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Noseclip | High Density Polyethylene(HDPE) | Polypropylene, metal wire | Different | |
| Earloops | Nylon and Spandex | Nylon and Spandex | Same | |
| Color | White | Blue | Different | |
| Dimension(length) | $175mm \pm 5mm$ | $175mm \pm 2mm$ | Same | |
| Dimension(Width) | $95mm\pm5mm$ | $95mm\pm2mm$ | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100-19level | Level 3 | Level 3 | Same | |
| Biocompatibility | Meet ISO10993 ,proved non-cytotoxicity, non-irritating andnon-sensitizing | Meet ISO10993 ,proved non-cytotoxicity, non-irritating and non-sensitizing | Same |
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From the comparison we found the material of proposed device's nose clip and its color were different from the predicate device. The biocompatibility tests were conducted to both components to ensure their compliance to the ISO10993-5 and ISO10993-10. There is no new risk generated from the difference of the material.
G. Non-Clinical Test Conclusion
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with 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:
- ISO 10993-5: 2009 Biological Evaluation of Medical Devices -- Part 5: Tests For In Vitro A Cytotoxicity
-
ISO 10993-10: 2010 Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- A ASTM F2100, Standard Specification for Performance of Materials Used In Medical Face Masks
- A ASTM F1862, Standard Test Method for Resistance of Medical Face Masks To Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume At A Known Velocity);
-
EN 14683, Medical Face Masks-Requirements and Test Methods;
-
ASTM F2101, Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol of Staphylococcus Aureus;
- A ASTM F2299, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres;
- A 16 CFR 1610, Standard for the Flammability of clothing textiles;
| Item | Purpose | Proposed device | AcceptanceCriteria | Result |
|---|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862 | Assess theperformance of amask to resistanceto a synthetic bloodpreparationtargeted toward themask at a setpressure | 3 non-consecutivelots tested, using asample size of32/lot.32 out of 32 pass at160 mmHg | 29 out of 32 pass at160 mmHg forlevel 3 | PASS |
| ParticulateFiltrationEfficiency ASTMF2299 | Assess theperformance ofa mask topenetration bysub-micronpolystyrenelatex particles of0.1 micron | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 99.35%Lot2: 99.46%Lot3: 98.69% | ≥ 98% | PASS |
| BacterialFiltrationEfficiency ASTMF2101 | Assess theperformance ofa mask topenetration by aprepared solutionwith knownconcentration ofan indicatorbacterial organism | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 99.88%Lot2: 99.87%Lot3: 99.88% | ≥ 98% | PASS |
| DifferentialPressure (Delta P)EN 14683 AnnexC | Assess theperformance ofa mask forresistance toair movementthrough thematerials of theface of the mask | 3 non-consecutivelots tested, using asample size of32/lot.Lot1: 4.13mmH2O/cm²Lot2: 4.18mmH2O/cm²Lot3: 4.24mmH2O/cm² | < 6.0mmH2O/cm² | PASS |
| Flammability 16CFR 1610 | Assess theresistance of amask to ignition | 3 non-consecutivelots tested, using asample size of32/lot.Class I | Class I | PASS |
Table 2 - Performance Testing
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Wellmed Dental Medical Supply Co.,Ltd
301 Zhongxing Science and Technology Building,No.64,Xin'an 2nd Road, Baoan District, Shenzhen, China.
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Wellmed Dental Medical Supply Co.,Ltd
301 Zhongxing Science and Technology Building,No.64,Xin'an 2nd Road, Baoan District, Shenzhen, China.
Table 3 – Biocompatibility Testing
| Test Method | Purpose | Acceptance Criteria | Result |
|---|---|---|---|
| Cytotoxicity | Assess the potential risk of Cytotoxicity of mask material | Non-Cytotoxic | PASSUnder the conditions of the study, the device is non-cytotoxic. |
| Irritation | Assess the potential risk of Irritation of mask material | Non-Irritating | PASSUnder the conditions of the study, the device is non-irritating. |
| Sensitization | Assess the potential risk of Sensitization of mask material | Non-Sensitizing | PASSUnder the conditions of the study, the device is non-sensitizing |
H. Clinical Test Conclusion
No clinical study is included in this submission.
I. Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission, the Disposable Medical Face Mask (Model: DF3-001) is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K213806.
§ 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.