(206 days)
The Single-use Medical 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.
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use. The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire. It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled. The product is level 2 according to ASTM F2100-19.
This is a 510(k) premarket notification for a medical device (Single-use Medical Face Mask), not an AI/ML-enabled device. Therefore, many of the requested categories for AI/ML study design and performance evaluation are not applicable.
However, I can extract the acceptance criteria and performance data for the medical face mask as presented in the document.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Acceptance Criteria (Level 2 ASTM F2100) | Reported Device Performance (Average for 3 lots) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 98% | 99.77% |
| Sub-Micron Particle Filtration Efficiency | ≥ 98% | 99.80% |
| Differential Pressure, mm H2O/cm² | < 6.0 mm H₂O/cm² | 4.01 mmH2O/cm² |
| Flammability | Class 1 | Class 1 (Non-Flammable) |
| Resistance to Penetration by Synthetic Blood | Pass at 120 mmHg | Pass at 120 mmHg |
| Cytotoxicity | Pass (Not cytotoxic) | Pass |
| Sensitization | Pass (Not a sensitizer) | Pass |
| Skin Irritation | Pass (Not an irritant) | Pass |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: For the performance tests (Flammability, BFE, Differential Pressure, Sub-Micron Particle Filtration Efficiency, Resistance to Penetration by Synthetic Blood), the study used 3 non-consecutive lots, with 32 samples per lot. The total number of samples tested for each of these performance criteria is 96 (3 lots x 32 samples/lot).
- Data Provenance: The document does not specify the country of origin of the data providers or if the data was retrospective or prospective, as these are not typically relevant for the physical performance testing of a medical mask. This information is usually provided by the manufacturer based on their internal testing protocols.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This is a medical device (face mask) with physical performance criteria, not an AI/ML-enabled device where expert human ground truth is established for image interpretation or diagnosis. The "ground truth" is determined by objective laboratory testing against established standards (ASTM F2100).
4. Adjudication Method for the Test Set
- Not applicable. As described above, the "ground truth" is determined by objective laboratory measurements against predefined thresholds, not by human expert consensus or adjudication.
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 medical device (face mask), not an AI/ML-enabled device requiring a clinical MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (face mask) with physical performance, not an AI/ML algorithm. The "standalone performance" is the direct physical testing of the mask's material properties.
7. The Type of Ground Truth Used
- The "ground truth" for the device's performance is established by objective laboratory measurements against recognized international standards and specifications (primarily ASTM F2100-19 and 16 CFR 1610 for flammability), as well as biocompatibility testing standards for cytotoxicity, irritation, and sensitization. These standards define the acceptable range or threshold for each performance characteristic.
8. The Sample Size for the Training Set
- Not applicable. This is a manufactured medical device, not an AI/ML model that requires a training set of data. The manufacturing process involves quality control and testing, but not "training" in the AI sense.
9. How the Ground Truth for the Training Set was Established
- Not applicable. See point 8.
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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: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.
July 2, 2021
Conod Medical Co., Limited % Olivia Meng Regulatory Affairs Manager Guangzhou Osmunda Medical Device Technical Service Co., Ltd. 8-9th Floor, R&D Building, No.26 Qinglan Street, Panyu District Guangzhou, Guangdong 510006 China
Re: K203591
Trade/Device Name: Single-use Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 6, 2021 Received: May 12, 2021
Dear Olivia Meng:
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.
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
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Indications for Use
510(k) Number (if known) K203591
Device Name Single-use Medical Face Mask
Indications for Use (Describe)
The Single-use Medical 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.
| 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
In accordance with 21 CFR 807.92 the following summary of information is provided:
1. SUBMITTER
Conod Medical Co., Limited No.11 Hongfeng Road, Baimao Industrial Park, Guli Town, Changshu City, Jiangsu Province, China Phone: +86-0512-52306320 Fax: +86-0512-52301831
| Primary Contact Person: | Olivia Meng |
|---|---|
| Regulatory Affairs Manager | |
| Guangzhou Osmunda Medical Device Technical Service Co., Ltd. | |
| Tel: (+86)-20-6231 6262 | |
| Fax: (+86)-20-8633 0253 | |
| Secondary Contact Person: | Ms. Carrie Wu |
| Compliance Director | |
| Conod Medical Co., Limited | |
| Phone: +86-0512-52306320 | |
| Fax: +86-0512-52301831 | |
| Date prepared | May 6th, 2021 |
- DEVICE
| Device Name: | Single-use Medical Face Mask |
|---|---|
| Common name: | Mask, Surgical |
| Model: | Earloop: ARR-DMM-175-50 |
| ARR-DMM-165-50 | |
| ARR-DMM-145-50 | |
| Tie Coverall: ARR-DTM-175-50 | |
| Regulation number | 21 CFR 878.4040 |
| Regulation Class: | II |
| Product Code: | FXX |
- PREDICATE DEVICE
K202719, Disposable Medical Face MasksThis predicate has not been subject to a design-related recall.
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DEVICE DESCRIPTION 4.
The Single-use Medical Face Mask is designed and manufactured by Conod Medical Co., Limited. It is non-sterile and for single use.
The Single-use Medical Face Mask has two models, Earloop and Tie Coverall. It is made of three-layer nonwovens, ear loops (for Earloop model)/ tie tapes (for Tie Coverall model) and nose piece. Inner and outer layers are made of spun-bond polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops/ tie tapes are held in place over the users' mouth and nose by two elastic ear loops/ tie tapes welded to the mask. The ear loops are made of polyester, and the tie tapes are made of spun-bond polypropylene. The nose piece in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable aluminum wire.
It is a self-inhalation filter mask, which works by filtering the air containing harmful substances through the filter material of the mask before being inhaled or exhaled.
The product is level 2 according to ASTM F2100-19. The main parameters of the product are listed as followed:
- . Bacterial filtration efficiency (BFE) ≥ 98%
- . Sub-micron particle filtration efficiency ≥ 98%
- . Different pressure: < 6.0 mm H₂O/cm²
- י Flammability: class 1
- . Resistance to penetration by synthetic blood: 120 mmHg
5. INDICATIONS FOR USE
The Single-use Medical 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE 6. DEVICE
| Item | Proposed device | Predicate device | Comparisonresult |
|---|---|---|---|
| Manufacturer | Conod Medical Co., Limited | Jiangxi Sanxin Medtec Co., Ltd. | NA |
| 510K Number | K203591 | K202719 | NA |
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| ProductCommonName | Single-use Medical Face Mask | Disposable Medical Face Masks | NA |
|---|---|---|---|
| Intended Use | The Single-use Medical FaceMasks are intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms, bodyfluids and particulate material.These face masks are intended foruse in infection control practicesto reduce the potential exposureto blood and body fluids. This is asingle use, disposable device(s),provided non-sterile. | The non-sterile disposablemedical face masks are intendedto be worn to protect both thepatient and healthcare personnelfrom transfer of microorganisms,body fluids and particulatematerial. These face masks areintended for use in infectioncontrol practices to reduce thepotential exposure to blood andbody fluids. This is a single use,disposable device, provided non-sterile. | Same |
| Mask style | Flat pleated | Flat pleated | Same |
| Design feature | Earloop, Tie Coverall, 3 layers | Ear-loop, Tie-on, 3 layers | Same |
| Material of outerfacing layer | Spun-bond polypropylene | Polypropylene non-woven fabric | Similar |
| Material of middlelayer | Melt blown polypropylene filter | Melt-blown polypropylene | Same |
| Material of innerfacing layer | Spun-bond Polypropylene | Polypropylene non-woven fabric | Similar |
| Nose piece | Malleable aluminum wire | Galvanized iron wire coated withpolypropylene | Different |
| Attachment | Ear loops: PolyesterTie tapes: Spun-bondPolypropylene | Ear strap (ear-loop): Polyesterand spandexEar strap (tie-on): Polypropylenenon-woven fabric | Similar |
| Color | Blue | Blue | Same |
| Dimension (Length× Width) | Earloop:17.5 cm × 9.5 cm16.5 cm × 9.0 cm14.5 cm × 9.5 cmTie Coverall:17.5 cm × 9.5 cm | Ear-loop:17.5 cm × 9.5 cm16.0 cm × 9.5 cm15.5 cm × 9.5 cm14.5 cm × 9.5 cm14.0 cm × 9.5 cmTie-on:Same as above | Similar |
| OTC use | Yes | Yes | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Single use | Yes | Yes | Same |
| ASTM F 2100 level | Level 2 | Level 2 | Same |
| Fluid ResistancePerformanceASTM F1862 | 32 out of 32 pass at 120mmHg | Pass at 120 mmHg | Same |
| ParticulateFiltrationEfficiency ASTMF2299 | Average 99.80% | 98.17% | Similar |
| BacterialFiltrationEfficiency ASTMF2101 | Average 99.77% | 98.38% | Similar |
| DifferentialPressure (DeltaP) ASTMF2100 | Average 4.01 mmH2O/cm² | 1.78 mmH2O/cm² | Similar |
| Flammability 16CFR 1610 | Class 1Non-Flammable | Class 1Non-Flammable | Same |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, not cytotoxic | Under the conditions of thestudy, not cytotoxic | Same |
| Irritation | Under the conditions of thestudy, not an irritant | Under the conditions of thestudy, not an irritant | Same |
| Sensitization | Under conditions of the study,not a sensitizer | Under conditions of the study,not a sensitizer | Same |
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The proposed Single-use Medical Face Mask and the predicate device are identical in the intended use, mask style, design feature, material, ASTM F2100 level and biocompatibility, and similar only in dimension and some components material.
7. PERFORMANCE DATA
The following performance data demonstrated in 3 non-consecutive lots were provided demonstrate that the subject device met the specification found in the standard. The results demonstrated that the subject device meets the acceptance criteria found in the standard.
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| Test item | Test purpose | Acceptance criteria | Results | |
|---|---|---|---|---|
| Performance test | Flammability | Testing the characteristics ofa material that pertain to itsrelative ease of ignition andrelative ability to sustain combustion. | Class 1ASTM F21003 non-consecutivelots, 32 samplesper lot | Pass |
| Bacterial FiltrationEfficiency | Testing the effectiveness ofmedical face mask materialin preventing the passage ofaerosolized bacteria. | Level 2: ≥ 98%ASTM F21003 non-consecutivelots, 32 samplesper lot | Pass | |
| Different Pressure,mm H2O/cm² | Measuring the pressure ofdropping across a medicalface mask material. | Level 2: < 6.0ASTM F21003 non-consecutivelots, 32 samplesper lot | Pass | |
| Sub-MicronParticle FiltrationEfficiency | Testing the efficiency of thefilter material in capturingaerosolized particles smallerthan one micron. | Level 2: ≥ 98%ASTM F21003 non-consecutivelots, 32 samplesper lot | Pass | |
| Resistance toPenetration bysynthetic blood | Testing the efficiency ofresistance to penetration bysynthetic blood. | Level 2: pass at120 mmHgASTM F21003 non-consecutivelots, 32 samplesper lot | Pass | |
| Biocompatibility | Cytotoxicity | Determining the cytotoxicityof proposed device. | Pass | Pass |
| Sensitization | Determining whether theproposed device hassensitization potential. | Pass | Pass | |
| Skin Irritation | Determining whether theproposed device hasirritation potential. | Pass | Pass |
8. CONCLUSION
The conclusions drawn from the nonclinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed 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.