(125 days)
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose. The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8) The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask. The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line. The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device. The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).
This document is a 510(k) summary for a Medical Surgical Mask (Models: MP002-5, MP002-6). The acceptance criteria and performance data provided relate to the physical and performance characteristics of the mask itself, rather than a diagnostic device with an AI algorithm. Therefore, many of the requested points regarding AI model evaluation (like sample size for test/training sets, expert consensus, MRMC studies, standalone performance) are not applicable to this submission.
Here is the information that can be extracted from the provided document, tailored to the type of device (a surgical mask):
1. A table of acceptance criteria and the reported device performance
The document compares the subject device to a predicate device and also lists specific performance test results against established standards.
| Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) | Test Method / Standard | Verdict for Subject Device |
|---|---|---|---|
| Fluid Resistance Performance | ASTM F1862 | ||
| 160 mmHg | 160 mmHg | Identical / Pass | |
| Particulate Filtration Efficiency | ASTM F2299-03 | ||
| 99.9% | ≥98% | Identical (Note 2) / Pass | |
| Bacterial Filtration Efficiency | ASTM F2101-14 | ||
| >99.9% | >99.9% | Identical / Pass | |
| Differential Pressure | EN 14683: 2019, Annex C | ||
| Pass at 2.7 mmH2O/cm² | <6.0 mmH2O/cm² | Identical (Note 2) / Pass | |
| Flammability | 16 CFR Part 1610 | ||
| Class 1 | Class 1 | Identical / Pass | |
| Cytotoxicity | ISO 10993-5:2009 | ||
| Non-cytotoxic | Non-cytotoxic | Identical / Pass | |
| Irritation | ISO 10993-10:2010 | ||
| Non-irritating | Non-irritating | Identical / Pass | |
| Sensitization | ISO 10993-10:2010 | ||
| Non-sensitizing | Non-sensitizing | Identical / Pass |
Note 2 in the original document states: "Although the "Particulate Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device."
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes (number of masks tested) for each physical performance test. However, it indicates that the tests conducted ("lab bench testing") are standard for demonstrating performance of such devices. The data provenance is implied to be from a testing facility in China, as the manufacturer is based there. The studies are by nature prospective, as they are conducted specifically for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the "ground truth" for this device is based on objective, quantifiable physical and biological tests conducted in a laboratory setting according to international standards (e.g., ASTM, ISO). It does not involve human expert interpretation or consensus as would be the case for an AI diagnostic device.
4. Adjudication method for the test set
Not applicable. Test results are based on objective measurements from laboratory instruments and procedures, not human adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
Not applicable. This is a physical medical device (surgical mask), not a diagnostic device involving human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. There is no algorithm or AI component to this device.
7. The type of ground truth used
The ground truth for this device is established through:
- Standardized Bench Testing: Performance metrics (e.g., filtration efficiency, pressure differential, fluid resistance, flammability) are measured using established ASTM and European (EN) standards.
- Biocompatibility Testing: Safety (cytotoxicity, irritation, sensitization) is assessed using ISO 10993 series standards.
These are objective, quantitative measurements against defined criteria.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device; therefore, there is no "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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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.
January 11, 2021
Jiangmen Sure&Me Medical Product CO., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920. Building D3, Miniie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong 510700 China
Re: K202577
Trade/Device Name: Medical Surgical Mask-Model MP002-5, MP002-6 Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: December 18, 2020 Received: December 22, 2020
Dear Cassie Lee:
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 (OS) 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 CAPT Elizabeth Claverie, M.S. 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) Applying
Device Name
Medical Surgical Mask (Model: MP002-5, MP002-6)
Indications for Use (Describe)
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
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 for K202577
1. Submitter's Information
510(k) Owner's Name: JIANGMEN SURE&ME MEDICAL PRODUCT CO., LTD,
Address: Jingshuiwan, Chakeng Village Committee, Huicheng Town, Xinhui District, Jiangmen City, Guangdong Province, China
Post Code: 529000
Contact Person: Liang Meixia
Phone: +86 18138977291
Fax: 0750-6393444
E-mail: mxliang1974@126.com
Application Correspondent:
Contact Person: Ms. Cassie Lee
Share Info (Guangzhou) Medical Consultant Ltd.
Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China
Tel: +86 20 8266 2446
Email: regulatory@glomed-info.com
2. Date of the summary prepared: 2021-01-09
3. Subject Device Information
Type of 510(k): Traditional
Classification Name: Mask, Surgical
Common name: Surgical Mask
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Trade Name: Medical Surgical Mask Models: MP002-5, MP002-6 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
4. Predicate Device Information
Sponsor: H&H RESEARCH COMPANY Trade Name: The New Medical Mask Classification Name: Mask, Surgical 510(K) Number: K093179 Review Panel: General Hospital Product Code: FXX Regulation Number: 878.4040 Regulatory Class: II
5. Device Description
The Medical Surgical Mask is flat style mask, model MP002-5 utilizing tie-on and model MP002-6 utilizing ear Loops way for wearing, and they all has nose clip design for fitting the face mask around the nose.
The Medical Surgical Masks are manufactured with three layers, the inner and outer layers are made of polypropylene, and the middle layer is made of polypropylene melt-blown. The color of the outer layer is blue (colorant: Copper phthalocyanine/ CAS number: 147-14-8)
The models of mask are ear loops and tie-on, masks are held in place over the users' mouth and nose by two high elastic spandex ear loops or bands welded to the face mask.
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The nose clip contained in the Medical Surgical Mask is in the layers of face mask to allow the user to fit the mask around their nose, which is made of plastic environmental protection line.
The Medical Surgical Mask are sold non-sterile and are intended to be single use, disposable device.
The dimension of the tie-on band (Model: MP002-5) is 25cm±2cm1cm±0.2cm (LW), and the dimension of the ear loop (Model: MP002-6) is 17cm±0.5cm0.4cm(LW). What's more, the dimension of the nose clip (Model: MP002-5, MP002-6) is 90mm2.5mm 0.45mm (LWH).
6. Intended Use / Indications for Use
This product is indicated for infection control practices in the health care industry. When worn properly, The Medical Surgical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.
7. Comparison to predicate device and conclusion
The differences between the subject device and predicate devices do not raise new issues of safety or effectiveness.
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | JIANGMEN SURE&MEMEDICAL PRODUCT CO., LTD | H&H RESEARCHCOMPANY | -- |
| 510 (k) | K202577 | K093179 | -- |
| Trade Name | Medical Surgical Mask | The New Medical Mask | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Identical |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Identical |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Intended use | This product is indicated forinfection control practices in thehealth care industry. When wornproperly, The Medical SurgicalMask is intended to protect bothpatient and wearer from thetransfer of microorganisms, bodyfluids and particulate material. | This product is indicated forinfection control practices inthe health care industry.When worn properly, TheNew Medical Mask isintended to protect bothpatient and wearer from thetransfer of microorganisms,body fluids and particulatematerial. | Identical |
| Material | |||
| Outer facinglayer | Polypropylene | Polypropylene | Identical |
| Middle layer | Polypropylene melt-blown | Polypropylene | IdenticalNote 1 |
| Inner facinglayer | Polypropylene | Polypropylene | Identical |
| Nose clip | Plastic environmental protectionline | Adhesive tape | IdenticalNote 1 |
| Ear Loops/Tie-on | Ear Loops/ Tie-on:High elastic spandex | Ear Loops: Non-latex elasticear bands | SimilarNote 1 |
| Designfeatures | Color: blue | Color: blue | Identical |
| Mask Style | Ear Loops (model: MP002-6)and Tie-on (model: MP002-5)flat style | Ear loopflat style | IdenticalNote 3 |
| Specificationand | 17.5cm x 9.5 cm | Length: 7.1 inches (18 cm) | Similar |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Dimension | Width: 3.9 inches (10 cm) | Note 3 | |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| PerformanceTesting | Level 3 | Level 3 | Identical |
| FluidResistancePerformance | 160 mmHg | 160 mmHg | Identical |
| ParticulateFiltrationEfficiency | ≥98% | 99.9% | IdenticalNote 2 |
| BacterialFiltrationEfficiency | >99.9% | >99.9% | Identical |
| DifferentialPressure | <6.0 mmH2O/cm² | Pass at 2.7 mmH2O/cm² | IdenticalNote 2 |
| Flammability | Class 1 | Class 1 | Identical |
| Latex | Not Made With Natural RubberLatex | Not Made With NaturalRubber Latex | Identical |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the device isnon-cytotoxic. | Under the conditions of thestudy, the device isnon-cytotoxic. | Identical |
| Irritation | Under the conditions of thestudy, the device isnon-irritating. | Under the conditions of thestudy, the device isnon-irritating. | Identical |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Sensitization | Under the conditions of thestudy, the device isnon-sensitizing | Under the conditions of thestudy, the device isnon-sensitizing | Identical |
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Comparison in Detail(s):
Note 1:
Although the "Middle layer", "Nose clip" and "Ear Loops" of subject device is slightly difference with predicate device, it meets the requirement standard ISO 10993. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 2:
Although the "Particulate Filtration Efficiency" and "Differential Pressure" of subject device is little difference with predicate device, it meets the requirement of essential performance standard ASTM 2100. The differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
Note 3:
Although the "Mask Style" and "Specification and Dimension" of subject device is little difference with predicate device, these dimensions differences between the predicate device and subject device will not affect the safety and effectiveness of the subject device.
8. Test Summary
Medical Surgical Mask (Models: MP002-6) has been evaluated the safety and performance by lab bench testing as following:
- � Biocompatibility test according to ISO 10993-5 and ISO 10993-10 standards
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- 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)
- ASTM F2101 Standard Test Method For Evaluating The Bacterial Filtration Efficiency ◆ (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus
- ASTM F2100 Standard Specification For Performance Of Materials Used In Medical • Face Masks
8.1 Summary of Non-Clinical Tests Performed:
| Test item | Test method | Pass criteria | Test results/Verdict |
|---|---|---|---|
| Bacterial filtrationefficiency | ASTM F2101-14Standard TestMethod forEvaluating theBacterial FiltrationEfficiency (BFE) ofMedical Face MaskMaterials, Using aBiological Aerosolof Staphylococcusaureus accordingto ASTMF2100:2019 | ≥ 98% | >99.9% / Pass |
| Differentialpressure (Delta-P) | EN 14683: 2019,Annex C Medicalface masks -Requirements andtest methodsaccording to ASTMF2100:2019 | <6.0 mm H2O/cm² | <6.0 mm H2O/cm²/ Pass |
| Sub-micronparticulate filtration | ASTM F2299-03Standard Test | ≥ 98% | ≥ 98% / Pass |
| efficiencyat 0.1 µm ofPolystyrene LatexSpheres | Method forDetermining theInitial Efficiency ofMaterials Used inMedical FaceMasks toPenetration byParticulates UsingLatex Spheresaccording to ASTMF2100:2019 | ||
| Resistance topenetration bysyntheticblood, minimumpressure in mm Hgfor pass result | ASTMF1862/F1862M-17Standard TestMethod forResistance ofMedical Face Masksto Penetration bySynthetic Blood(Horizontal Projectionof Fixed Volume at aKnown Velocity)according to ASTMF2100:2019 | Fluid resistantclaimedat 160 mm Hg | Fluid Resistantclaimed at 160 mmHg/ Pass |
| Flame spread | 16 CFR Part 1610Standard for theFlammability ofClothing accordingto ASTMF2100:2019 | Class 1 | Class 1 / Pass |
- Performance Testing summary
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● Biocompatibility Testing
According to ISO 10993-1:2009, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is B-prolonged (>24 h to 30 d). The
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following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use:
-
In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices-Part 5: Tests for in vitro cytotoxicity,
-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices-Part 10: Tests for irritation and skin sensitization,
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
8.2 Summary of Clinical Performance Test
No clinical study is included in this submission.
9. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K202577, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K093179.
§ 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.