(60 days)
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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, provided non-sterile.
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire. The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask (Model: JM92, JM92B) based on non-clinical testing for FDA 510(k) clearance, not a study involving human readers or AI. Therefore, I cannot provide information on points 2, 3, 4, 5, 8, and 9 as they are not applicable to this type of device submission.
Here is the information from the document related to acceptance criteria and device performance:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Item | Test Method | Acceptance Criteria for Level 1 | Acceptance Criteria for Level 3 | Reported Device Performance (Verdict) |
|---|---|---|---|---|
| Bacterial filtration efficiency | ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Differential pressure (Delta-P) | EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100: 2019 | < 5.0 mm H2O/cm² | < 6.0 mm H2O/cm² | Pass |
| Sub-micron particulate filtration efficiency | ASTM F2299 Standard Test Method for Determining the Initial Efficiency of Materials Used in Medical Face Masks to Penetration by Particulates Using Latex Spheres according to ASTM F2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance to penetration by synthetic blood | ASTM F1862/F1862M-17 Standard Test Method for Resistance of Medical Face Masks to Penetration by Synthetic Blood (Horizontal Projection of Fixed Volume at a Known Velocity) according to ASTM F2100: 2019 | Pass at 80 mmHg | Pass at 160 mmHg | Pass |
| Flame spread | 16 CFR Part 1610 Standard for the Flammability of Clothing according to ASTM F2100: 2019 | Class 1 | Class 1 | Pass |
| Biocompatibility (Cytotoxicity) | ISO 10993-5: 2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Non-cytotoxic | Non-cytotoxic | Conform to ISO 10993-5:2009 SE |
| Biocompatibility (Irritation) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Non-irritating | Non-irritating | Conform to ISO 10993-10:2010 SE |
| Biocompatibility (Sensitization) | ISO 10993-10: 2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (Note: The provided text only partially lists the standard for sensitization, but implies compliance.) | Non-sensitizing | Non-sensitizing | Conform to ISO 10993- SE |
2. Sample size used for the test set and the data provenance: Not applicable. This document pertains to non-clinical performance testing of a physical device (surgical mask), not a test set of data for an algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for non-clinical performance testing is established by standardized test methods and laboratory results, not expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This is not a study requiring adjudication of expert opinions.
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 for a surgical mask, not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for a surgical mask, not an algorithm.
7. The type of ground truth used:
For the performance tests (bacterial filtration efficiency, differential pressure, particulate filtration efficiency, resistance to synthetic blood, flame spread), the "ground truth" is defined by the requirements of the specific ASTM and EN standards used for testing (e.g., ASTM F2100, ASTM F2101, ASTM F2299, ASTM F1862, 16 CFR Part 1610). For biocompatibility, the "ground truth" is defined by the ISO 10993 series of standards (ISO 10993-5 and ISO 10993-10). The device is deemed to meet the acceptance criteria if its measured performance falls within the specified limits of these standards.
8. The sample size for the training set: Not applicable. This is for a physical device, not a machine learning model.
9. How the ground truth for the training set was established: Not applicable.
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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.
March 25, 2022
Guangdong Jia Mei Biological technology Co.Ltd % Ms. Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District Guangzhou, Guangdong China
Re: K220187
Trade/Device Name: Medical Surgical Mask (Model: JM92, JM92B) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: January 21, 2022 Received: January 24, 2022
Dear Ms. 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 (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.
Brent L. Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K220187
Device Name MEDICAL SURGICAL MASK (Model: JM92, JM92B)
Indications for Use (Describe)
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL MASK is intended for use in infection control practices to reduce the posure to blood and body fluids. This is a single-use, disposable device, provided non-sterile.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
Sponsor Name: Guangdong Jia Mei Biological technology Co.Ltd Address: 3/F, Block 1, No.356 Qinglan Road, Jianghai, Jiangmen City, Guangdong Province, China Post Code: 529040 Contact name: Jiali Chen Tel: +86-0750-3835982 E-mail: jmjaymei@163.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Company: 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@share-info.com
2. Date of the summary prepared: November 26, 2020
Revision date: January 21, 2022 3.
4. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: MEDICAL SURGICAL MASK Model Name: JM92, JM92B Review Panel: General Hospital Product Code: FXX Regulation: 21 CFR 878.4040 - Surgical apparel Regulatory Class: II
5. Predicate Device Information
Predicate Device 1 (Primary Predicate):
Sponsor: Jiangmen Ningrui Medical Supplies Co., Ltd.
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Trade Name: Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) Classification Name: Mask, Surgical 510(K) Number: K212293 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
Predicate Device 2:
Sponsor: Shandong Shengquan New Materials Co., Ltd. Trade Name: Surgical mask (Model: SMDP20608) Classification Name: Surgical Apparel 510(K) Number: K211552 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
6. Device Description
The subject device is a non-sterile, single-use, and flat pleated mask with ear loops and a Nose piece. The product is manufactured with three layers, the inner and outer layer is made of polypropylene spunbond, the middle layer is made of melt blown polypropylene. The elastic ear loops are not made with natural rubber latex. The Nose piece in the facemask is to allow the user to fit the facemask around their nose, which is made of polyethylene coated iron wire.
The mask will be provided in black and blue color, the colorant for the model JM92B is Carbon black (CAS No.1333-86-4), and for the model JM92 is Pigment Blue 15 (CAS No.147-14-8). The model JM92 will be provided in blue and labeled in Level 3, the model JM92B will be provided in black and labeled in Level 1.
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7. Intended Use / Indications for Use
The MEDICAL SURGICAL MASK is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. The MEDICAL SURGICAL 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, provided non-sterile.
8. 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 1 | Predicate Device 2 | Remark |
|---|---|---|---|---|
| Company | Guangdong Jia MeiBiologicaltechnology Co.Ltd | Jiangmen Ningrui MedicalSupplies Co., Ltd. | ShandongShengquan NewMaterials Co., Ltd. | -- |
| 510 (k) | Applying | K212293 | K211552 | -- |
| Trade Name | MEDICALSURGICAL MASK | Surgical Mask | Surgical mask | -- |
| Model | JM92, JM92B | WK1701-02A, WK1701-03A,WK1701-04A | SMDP20608 | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Surgical Apparel | SE |
| Classification | Class II | Class II | Class II | SE |
| Product Code | FXX | FXX | FXX | SE |
| Intended use | The MEDICALSURGICAL MASKis intended to beworn to protect boththe patient andhealthcarepersonnel fromtransfer ofmicroorganisms,body fluids, andparticulate material.These face masksare intended for use | The Surgical Mask is intendedto be worn to protect both thepatient and healthcarepersonnel from the transfer ofmicroorganisms, body fluids,and particulate material. TheSurgical Mask is intended foruse in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device(s), providednon-sterile. | The surgical masksare intended to beworn to protect boththe patient andhealthcare personnelfrom transfer ofmicroorganisms,body fluids andparticulate material.These surgicalmasks are intendedfor use in infectioncontrol practices to | SE |
| Elements ofComparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark |
| in infection controlpractices to reducethe potentialexposure to bloodand body fluids. Thisis a single-use,disposable device,provided non-sterile. | reduce the potentialexposure to bloodand body fluids. Thisis a single use,disposable device,and provided non-sterile. | |||
| Materials | ||||
| Outer facinglayer | Polypropylenespunbond | Polypropylene spunbond fabric | PolypropyleneSpunbond | SE |
| Middle filterlayer | Melt blownpolypropylene | Polypropylene meltblown fabric | Melt blownpolypropylene filter | SE |
| Inner facinglayer | Polypropylenespunbond | Polypropylene spunbond fabric | PolypropyleneSpunbond | SE |
| Nose piece | Polyethylene coatediron wire | Polypropylene coatedgalvanized iron wire | Malleablepolyethylene | SENote 1 |
| Ear loops | Spandex | Nylon, spandex | Spandex, Polyester | SENote 1 |
| Mask Style | Flat-pleated | Flat-pleated | Flat-pleated | SE |
| Color | Blue (JM92), Black(JM92B) | Blue | Black and White | SE |
| Dimensions | Length: 17.5 cm$\pm$ 5%Width: 9.5 cm $\pm$ 5% | Length: 17.5 cm $\pm$ 5mmWidth: 9.5 cm $\pm$ 3mm | Length:17.5cm $\pm$ 0.88cmWidth:9.5cm $\pm$ 0.48cm | SE |
| OTC use | Yes | Yes | Yes | SE |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | SE |
| Single-use | Yes | Yes | Yes | SE |
| PerformanceTesting | Level 1, Level 3 | Level 1; Level 2; Level 3 | Level 3 | SE |
| Level | Level 1(JM92B) | Level 1 | Level 3 | / |
| Fluid | Pass at | Pass at | Passed at 29 out of | SE |
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| Elements of Comparison | Subject Device | Predicate Device 1 | Predicate Device 2 | Remark | ||
|---|---|---|---|---|---|---|
| Resistance Performance (ASTM F1862) | 80 mmHg | 160 mmHg | 80 mm Hg | 120 mm Hg | 160 mm Hg | 32 pass at 160 mmHg |
| Particulate Filtration Efficiency (ASTM F1215) | Pass at ≥ 95% | Pass at ≥ 98% | Pass at ≥ 99% | Pass at ≥ 99% | Pass at ≥ 99% | ≥98% SE Note 2 |
| Bacterial Filtration Efficiency (ASTM F2101) | Pass at ≥ 95% | Pass at ≥ 98% | Pass at ≥ 99% | Pass at ≥ 99% | Pass at ≥ 99% | ≥98% SE Note 2 |
| Differential Pressure (ASTM F2100) | Pass at < 5.0 mm H2O/cm² | Pass at < 6.0 mm H2O/cm² | Pass at < 3.4 mmH2O /cm² | Pass at < 3.5 mmH2O /cm² | Pass at < 3.4 mmH2O /cm² | <6.0 mm H2O/cm² SE Note 2 |
| Flammability | Class 1 | Class 1 | Class 1 | SE | ||
| Biocompatibility | Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Conform to ISO 10993-5:2009 SE | ||
| Irritation | Non-irritating | Non-irritating | Conform to ISO 10993-10:2010 SE | |||
| Sensitization | Non-sensitizing | Non-sensitizing | Conform to ISO 10993- SE |
Comparison in Detail(s):
Note 1:
Although the "Nose piece" and "Ear loops" of subject device are a little different from predicate devices,
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they all met the requirements of biocompatibility standard ISO 10993-5 and ISO 10993-10. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
Note 2:
Although the "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency" and "Differential Pressure" of subject device is a little different from predicate devices, they all met the requirements of performance standard ASTM F2100. So, the differences between the subject device and predicate devices will not affect the safety and effectiveness.
9. Summary of Non-Clinical Performance Testing
| Pass criteria | Testresults/Verdict | |||
|---|---|---|---|---|
| Test item | Test method | For Level1 | For Level3 | |
| Bacterialfiltrationefficiency | ASTM F2101-19 Standard TestMethod for Evaluating the BacterialFiltration Efficiency (BFE) of MedicalFace Mask Materials, Using aBiological Aerosol of Staphylococcusaureus according to ASTM F2100:2019 | ≥ 95% | ≥ 98% | Pass |
| Differentialpressure(Delta-P) | EN 14683: 2019, Annex C Medicalface masks - Requirements and testmethods according to ASTM F2100:2019 | <5.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micronparticulatefiltrationefficiency at 0.1µm ofPolystyreneLatex Spheres | ASTM F2299 Standard Test Methodfor Determining the Initial Efficiency ofMaterials Used in Medical Face Masksto Penetration by Particulates UsingLatex Spheres according to ASTMF2100: 2019 | ≥ 95% | ≥ 98% | Pass |
| Resistance topenetration by | ASTM F1862/F1862M-17Standard Test Method for Resistance of | Passat 80 mm | Passat 160 mm | Pass |
Performance Testing summary
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| synthetic blood,minimumpressure in mmHg for passresult | Medical Face Masks to Penetration bySynthetic Blood (Horizontal Projection ofFixed Volume at a Known Velocity)according to ASTM F2100:2019 | Hg | Hg | |
|---|---|---|---|---|
| Flame spread | 16 CFR Part 1610 Standard for theFlammability of Clothing according toASTM F2100:2019 | Class 1 | Class 1 | Pass |
Biocompatibility Testing
According to ISO 10993-1: 2018, the nature of body contact for the subject device is Surface Device category, Skin Contact and duration of contact is A-prolonged (<24 h). The 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.
10. Summary of Clinical Performance Test
No clinical study is included in this submission.
11. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrate that the subject device MEDICAL SURGICAL MASK (Model: JM92, JM92B) is substantially equivalent to the legally marketed devices identified in K212293 and K211552.
§ 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.