(162 days)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose. The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene. Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex. The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin. The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm. The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.
The document provided describes the acceptance criteria and performance of a Medical Surgical Mask (Model: KF-B P05) by Guangdong KINGFA Sci.&Tech.Co.,Ltd. Rather than an AI device being proven to meet acceptance criteria, this is a 510(k) summary for a medical device (a mask) demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's the breakdown of the information requested, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against ASTM F2100:2019 Level 1 performance requirements.
| Test Item (Performance Level 1) | Acceptance Criteria (Pass Criteria) | Reported Device Performance (Test Results) |
|---|---|---|
| Bacterial Filtration Efficiency (BFE) | ≥ 95% | 99.2% |
| Differential Pressure (Delta-P) | <5.0 mm H2O/cm² | <5.0 mm H2O/cm² |
| Sub-micron Particulate Filtration Efficiency (PFE) at 0.1 µm of Polystyrene Latex Spheres | ≥ 95% | 99.46% |
| Resistance to penetration by synthetic blood, minimum pressure in mm Hg for pass result | Fluid resistant claimed at 80 mm Hg | Fluid Resistant claimed at 80 mm Hg |
| Flame spread | Class 1 | Class 1 |
Biocompatibility Tests: The device also underwent biocompatibility testing according to ISO 10993-1:2009 for skin contact, with the following results:
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not explicitly state the sample sizes used for each non-clinical performance test (e.g., number of masks tested for BFE, PFE, etc.). It only provides the test methods and results.
The testing was performed according to international standards (ASTM and EN for performance, ISO for biocompatibility). The manufacturer is Guangdong KINGFA SCI.&TECH.Co.,Ltd. from China, so it is assumed the tests were conducted in facilities that are likely in China or by labs accredited to these standards. The nature of these tests is prospective as they are conducted specifically for the purpose of demonstrating device safety and effectiveness for regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This question is not applicable to this type of device. The "ground truth" for a medical surgical mask is established by validated scientific test methods (e.g., ASTM F2101 for BFE, ASTM F2299 for PFE) and regulatory standards (e.g., ASTM F2100 for medical face mask performance, ISO 10993 for biocompatibility). These methods have predefined criteria for success or failure, not expert consensus as would be used for image interpretation in AI.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies involving interpretation of medical images or patient outcomes, often with human readers. For this device, objective laboratory tests with defined protocols and metrics determine the performance.
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
This question is not applicable. This submission is for a physical medical device (a surgical mask), not an AI algorithm. Therefore, no MRMC study or assessment of AI assistance was performed or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable. This is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for the device's performance is established by the standardized test methods and their defined pass/fail criteria. For example:
- Bacterial Filtration Efficiency: Measured quantitatively as a percentage (≥95% is the pass criterion).
- Differential Pressure: Measured quantitatively in mm H2O/cm² (<5.0 mm H2O/cm² is the pass criterion).
- Biocompatibility: Determined by laboratory assessments (e.g., in vitro cell cultures for cytotoxicity, animal models or human patch tests for irritation/sensitization) against predefined biological response levels.
8. The sample size for the training set
This question is not applicable. This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
This question is not applicable. No training set exists for this type of 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.
November 24, 2020
Guangdong KINGFA Sci.&Tech.Co.,Ltd. % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K201622
Trade/Device Name: Medical surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: October 15, 2020 Received: October 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
For CAPT Elizabeth Claverie Assistant Director DHT4B: Division of Health Technology 4B 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) K201622
Device Name
Medical surgical mask (Model: KF-B P05)
Indications for Use (Describe)
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters This device is single use and provided non-sterile.
Prescription Use (Part 21 CFR 801 Subpart D)
|X Over-The-Counter Use (21 CFR 801 Subpart C)
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Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary
510(k) Summary for K201622
1. Submitter's Information
510(k) Owner's Name: Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Address: 28 Delong Avenue, Shijiao Town, Qingcheng District, Qingyuan City, Guangdong Province, China
Post Code: 511500
Contact Person: Yu Xiaoge
Tel: +86 2632 8999
Fax: +0763-3203108
Email: yuxiaoge@kingfa.com.cn
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: June 10, 2020
Revision date: November 24, 2020
3. Subject Device Information
Type of 510(k): Traditional
Classification Name: Mask, Surgical
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Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd. Subject Device: Medical surgical mask (Model: KF-B P05) Document Name: 510(k) summary
Common name: Surgical Mask
510(K) Number: K201622
Trade Name: Medical surgical mask
Model Name: KF-B P05
Review Panel: Surgical Apparel
Product Code: FXX
Regulation Number: 878.4040
Regulatory Class: 2
4. Predicate Device Information
Sponsor: Protect U Guard, LLC
Trade Name: Protect U Guard Earloop and Tie-On Mask (Blue, White or Green)
Classification Name: Mask, Surgical
Common name: Surgical Mask
510(K) Number: K153409
Review Panel: Surgical Apparel
Product Code: FXX
Regulation Number: 878.4040
Regulation Class: 2
5. Device Description
The Medical surgical mask is flat pleated style mask, utilizing ear Loops way for wearing, and they all have nose piece design for fitting the Medical surgical mask around the nose.
The Medical surgical mask is manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: Pigment Blue K6911D /CAS number: 12239-87-1), and the middle layer is made of melt blown polypropylene.
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| Sponsor: | Guangdong KINGFA SCI.&TECH.Co.,Ltd. |
|---|---|
| Subject Device: | Medical surgical mask (Model: KF-B P05) |
| Document Name: | 510(k) summary |
Ear loops, which is held to cover the users' mouth and nose by two polyester and spandex elastic bands ultrasonic welded to the Medical surgical mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Medical surgical mask is in the middle layer of Medical surgical mask to allow the user to fit the Medical surgical mask around their noses, which is made of metallic iron wire coated with polypropylene resin.
The dimensions of each Medical surgical mask are length 175±5 mm and width 95±2 mm, and the inner and outer layers' density are 25 gsm, the middle layer is 35 gsm. The dimensions of nosepiece is length 100±5 mm and width 3±0.5 mm, and the ear loop is length 175±10 mm and width 3.5±0.5 mm.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device.
6. Intended Use / Indications for Use
Medical surgical mask is intended for use by healthcare workers during procedures to protect both patients and healthcare workers against transfer of microorganisms, bodily fluids, and particulate matters. This device is single use and provided non-sterile.
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 | Guangdong KINGFASCI.&TECH.Co.,Ltd. | Protect U Guard, LLC | -- |
| 510 (k) | K201622 | K153409 | -- |
| Trade Name | Medical surgical mask | Protect U Guard Earloop andTie-On Mask (Blue, White or | -- |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Green) | |||
| ClassificationName | Mask, Surgical | Mask, Surgical | Identical |
| Classification | Class II Device, FXX (21CFR878.4040) | Class II Device, FXX (21CFR878.4040) | Identical |
| Intended use/Indicationsfor Use | Medical surgical mask isintended for use by healthcareworkers during procedures toprotect both patients andhealthcare workers againsttransfer of microorganisms,bodily fluids, and particulatematters. This device is singleuse and provided non-sterile. | Earloop Mask and Tie-On Maskis intended for use by healthcareworkers during procedures toprotect both patients andhealthcare workers againsttransfer of microorganisms,bodily fluids, and airborneparticles. This device issingle use and providednon-sterile. | Identical |
| Material | |||
| Outer facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Identical |
| Inner facinglayer | Spun-bond polypropylene | Spun-bond polypropylene | Identical |
| Nose piece | Polypropylene and metallic iron | Aluminum strip | SimilarNote 1 |
| Ear loops | Polyester and spandex elasticband | Urethane elastic fiber | SimilarNote 1 |
| Designfeatures | Color: blue | Color: Blue, White and Green | SimilarNote 1 |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Mask Style | EarloopFlat Pleated | Earloop or Tie-OnFlat Pleated | Identical |
| SpecificationandDimension | 9.5cm x 17.5 cm | 9.5cm x 17.7 cm | Identical |
| OTC use | Yes | Yes | Identical |
| Sterility | Non-Sterile | Non-Sterile | Identical |
| Use | Single Use, Disposable | Single Use, Disposable | Identical |
| PerformanceTesting(according toASTM-2100:2019) | Level 1 | Level 1 | Identical |
| FluidResistancePerformance | Pass at 80 mmHg | Pass at 80 mmHg | Identical |
| ParticulateFiltrationEfficiency | 99.46% | 99.18% | SimilarbetterNote 2 |
| BacterialFiltrationEfficiency | 99.2% | 99.17% | SimilarbetterNote 2 |
| DifferentialPressure | <5.0 mm H2O/cm² | 3.79 mmH2O/cm² | SimilarNote 2 |
| Flammability | Class 1 | Class 1 | Identical |
| Latex | Not Made With Natural RubberLatex | Not Made With Natural RubberLatex | Identical |
| Elements ofComparison | Subject Device | Predicate Device | Verdict |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the subject device extractwas determined to benon-cytotoxic. | Under the conditions of thestudy, the subject device extractwas determined to benon-cytotoxic. | Identical |
| Irritation | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-irritating. | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-irritating. | Identical |
| Sensitization | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-sensitizing. | Under the conditions of thestudy, the subject devicenon-polar and polar extractswere determined to benon-sensitizing. | Identical |
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Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device: Medical surgical mask (Model: KF-B P05)
Document Name: 510(k) summary
Sponsor:
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Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device: Medical surgical mask (Model: KF-B P05)
Document Name: 510(k) summary
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Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device: Medical surgical mask (Model: KF-B P05)
Document Name: 510(k) summary
Comparison in Detail(s):
Note 1:
Although the "Design features", "Nose piece" and "Ear loops" of subject device is little difference with predicate device, it meet 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 "Fluid Resistance Performance", "Particulate Filtration Efficiency", "Bacterial Filtration Efficiency", "Differential Pressure" and "Specification and Dimension" of subject device is little difference with predicate device, it meet 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.
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8. Summary of Non-Clinical Tests Performed:
- Performance Testing summary
| Test item(PerformanceLevel 1) | 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 | ≥ 95% | 99.2% / Pass |
| Differentialpressure (Delta-P) | EN 14683: 2019,Annex C Medicalface masks -Requirements andtest methodsaccording to ASTMF2100:2019 | <5.0 mm H2O/cm² | <5.0 mm H2O/cm²/ Pass |
| Sub-micronparticulate filtrationefficiencyat 0.1 µm ofPolystyrene LatexSpheres | ASTM F2299-03Standard TestMethod forDetermining theInitial Efficiency ofMaterials Used inMedical FaceMasks toPenetration by | ≥ 95% | 99.46% / Pass |
| Particulates 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 80 mm Hg | Fluid Resistantclaimed at 80 mm Hg/ Pass |
| Flame spread | 16 CFR Part 1610Standard for theFlammability ofClothing accordingto ASTMF2100:2019 | Class 1 | Class 1 / Pass |
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Sponsor: Guangdong KINGFA SCI.&TECH.Co.,Ltd.
Subject Device: Medical surgical mask (Model: KF-B P05)
Document Name: 510(k) summary
● 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 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,
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| Sponsor: | Guangdong KINGFA SCI.&TECH.Co.,Ltd. |
|---|---|
| Subject Device: | Medical surgical mask (Model: KF-B P05) |
| Document Name: | 510(k) summary |
- Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical devices— Part 10: Tests for irritation and skin sensitization.
9. Summary of Clinical Performance Test
No clinical study is included in this submission.
10. Final Conclusion:
The conclusion drawn from the nonclinical tests demonstrates that the subject device Medical surgical mask in 510(k) K201622, is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153409.
§ 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.