(54 days)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
This document describes the acceptance criteria and the study results for the Guangdong Golden Leaves Technology Development Co., LTD's Medical Protective Mask (models 8862, 8862A, 8862B, 8862C, 8862D, 8862E), as presented in their 510(k) Summary (K223068).
1. Table of Acceptance Criteria and Reported Device Performance
The device is evaluated against the ASTM F2100 standard for Medical Face Mask Materials. All models (Level 1, Level 2, and Level 3) of the Medical Protective Mask are stated to meet the performance requirements of all three levels.
| Test Item | Test Method | Acceptance Criteria (Level 1) | Reported Performance (Level 1) | Acceptance Criteria (Level 2) | Reported Performance (Level 2) | Acceptance Criteria (Level 3) | Reported Performance (Level 3) | Verdict |
|---|---|---|---|---|---|---|---|---|
| Bacterial Filtration Efficiency | ASTM F2101-19 | ≥ 95% | Pass | ≥ 98% | Pass | ≥ 98% | Pass | Pass |
| Differential Pressure (Delta-P) | EN 14683: 2019, Annex C | < 5.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass | < 6.0 mm H2O/cm² | Pass | Pass |
| Particulate Filtration Efficiency (0.1 µm) | ASTM F2299 | ≥ 95% | Pass | ≥ 98% | Pass | ≥ 98% | Pass | Pass |
| Resistance to Synthetic Blood Penetration | ASTM F1862/F1862M-17 | Pass at 80 mmHg | Pass | Pass at 120 mmHg | Pass | Pass at 160 mmHg | Pass | Pass |
| Flammability | 16 CFR Part 1610 | Class 1 | Pass | Class 1 | Pass | Class 1 | Pass | Pass |
Biocompatibility Testing
| Title of the test | Reference for Test method | Acceptance Criteria | Test Results |
|---|---|---|---|
| In vitro Cytotoxicity Test | ISO 10993-5:2009 | Under the conditions of the study, the subject device extract was determined to be non-cytotoxic. | Pass |
| Skin Sensitization Test | ISO 10993-10:2010 | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-sensitizing. | Pass |
| Skin Irritation Test | ISO 10993-10:2010 (Part 23: Tests for irritation and skin sensitization) | Under the conditions of the study, the subject device non-polar and polar extracts were determined to be non-irritating. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each performance and biocompatibility test. It indicates that the tests were conducted according to the specified ASTM and ISO standards, which would implicitly define minimum sample sizes for valid results. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective, but it's generated for the purpose of this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The "ground truth" for this device is based on standardized performance and biocompatibility testing according to recognized international standards (ASTM, ISO, EN, 16 CFR). These standards define specific methodologies and criteria, rather than relying on expert consensus for interpreting test results.
4. Adjudication Method for the Test Set
Not applicable. The assessment relies on objective measurements against predefined thresholds as per the referenced standards, not on an adjudication process involving human reviewers for interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices that involve human interpretation of images or other data. The Medical Protective Mask is a physical barrier device, and its effectiveness is determined by its material properties and physical performance as measured by objective tests.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, the studies conducted were standalone performance tests of the device itself, without human-in-the-loop performance evaluation. The performance criteria (e.g., filtration efficiency, fluid resistance) are objective measurements of the mask's physical characteristics.
7. The Type of Ground Truth Used
The ground truth used for evaluating the Medical Protective Mask's performance is based on established international standards and testing methodologies. For example:
- Performance data: Directly measured physical properties (e.g., filtration rates, pressure differential, fluid penetration, flammability) against the numerical thresholds defined by ASTM F2100:2019, EN 14683: 2019, and 16 CFR Part 1610.
- Biocompatibility data: Laboratory test results (cytotoxicity, sensitization, irritation) against the criteria defined by ISO 10993-5:2009 and ISO 10993-10:2010.
8. The Sample Size for the Training Set
Not applicable. This device is a medical mask evaluated by its physical properties and biocompatibility. There is no "training set" in the context of machine learning or AI models. The testing described is for the final product's performance validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this device. The regulatory submission focuses on demonstrating that the physical device meets established performance and safety standards through non-clinical testing.
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November 23, 2022
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Guangdong Golden Leaves Technology Development Co., LTD % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 523000 China
Re: K223068
Trade/Device Name: Medical Protective Mask (model: 8862, 8862B, 8862C, 8862D, 8862E) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: September 28, 2022 Received: September 30, 2022
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.
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
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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,
Anne D. Talley -S
for
Brent 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) K223068
Device Name
Medical Protective Mask (model: 8862, 8862A, 8862C, 8862C, 8862D, 8862E)
Indications for Use (Describe)
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide non-sterile.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
For activities where HUD funding is NOT being directly obligated or expended
For activities where HUD funding IS being directly obligated or expended
| | 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 of K223068
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 Golden Leaves Technology Development Co., Ltd. Address: 5F, BLDG 2, #8, Qiaolonghe East Rd, Tangxia Town, Dongguan, Guangdong, 523730, China Post Code: 523730 Contact name: Wenhong Zhou Tel: +86-13416994806 E-mail: info@gdgoldenleaves.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: Jun 26, 2022
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Trade Name: Medical Protective Mask Model Name: 8862, 8862A, 8862B, 8862C, 8862D, 8862E Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
4. Predicate Device Information
Predicate Device:
Sponsor: Jiangxi Hongda Medical Equipment Group Co., Ltd. Trade Name: Single-Use Medical Face Mask Classification Name: Mask, Surgical
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510(K) Number: K210622 Review Panel: General Hospital Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulation Class: II
5. Device Description
The subject device is a four-layer, single-use, flat-folded shape mask. The inner and outer layers of the mask are made of polypropylene spunbonded nonwoven, and the filter (2 layers) is made of polypropylene melt-blown nonwoven. The proposed devices are available in two types, ear loop and headband. The ear loops and headband are made of polyester. The nose clip is made of polypropylene and wire, user can adjust the nose clip according to the shape of the nose, and fix the mask on the bridge of the nose to prevent the mask from falling off.
| TypeLevel | Ear Loop | Headband |
|---|---|---|
| Level 1 | 8862B | 8862E |
| Level 2 | 8862A | 8862D |
| Level 3 | 8862 | 8862C |
Both the ear loop and headband masks are available in level 1, level 2 and level 3:
All models are made of the same material and have identical performance, meeting the performance requirements of three levels at the same time.
The device is provided non-sterile.
6. Intended Use / Indications for Use
The Medical Protective Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material. These 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, provide 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 1 | Verdict |
|---|---|---|---|
| Company | Guangdong Golden LeavesTechnology Development Co., | Jiangxi Hongda MedicalEquipment Group Co., Ltd. | -- |
| Elements ofComparison | Subject Device | Predicate Device 1 | Verdict |
| Ltd. | |||
| 510 (k) | K223068 | K210622 | -- |
| Trade Name | Medical Protective Mask | Single-Use Medical Face Mask | -- |
| ClassificationName | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II | Class II | Same |
| Product Code | FXX | FXX | Same |
| Intended use | The Medical Protective Maskis intended to be worn toprotect both the patient andhealthcare personnel fromtransfer of microorganisms,body fluids, and particulatematerial. These masks areintended for use in infectioncontrol practices to reduce thepotential exposure to bloodand body fluids. This is asingle-use, disposable device,provide non-sterile. | 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 intendedfor use in infection controlpractices to reduce the potentialexposure to blood and bodyfluids. This is a single-use,disposable device,provided sterile and non-sterile. | Same |
| Mask style | Flat-folded | Flat-pleated | Same |
| Design feature | Ear loop, headband | Ear loop or tie-on | SimilarNote 1 |
| Color | Green | White | DifferentNote 1 |
| Dimension | Mask body: 205x80mmNose clip: 100mmEar loop: 150mmHeadband: 350mm | Mask body: 175x95mmNose Clip: 80 | SimilarNote 1 |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Materials | |||
| Outer facing layer | Polypropylene SpunbondedNonwoven | Polypropylene SpunbondedNonwoven | Same |
| Elements ofComparison | Subject Device | Predicate Device 1 | Verdict |
| Filter layer | Polypropylene Melt-blownNonwoven | Polypropylene Melt-blownNonwoven | Same |
| Inner facing layer | Polypropylene SpunbondedNonwoven | Polypropylene SpunbondedNonwoven | Same |
| Nose Clip | Polypropylene and wire | Polypropylene and iron | SimilarNote 1 |
| Earloops/headband | Polyester | Polyester and spandex | SimilarNote 1 |
| Performance Characteristics | |||
| ASTM F2100Level | Level 1, Level 2, Level 3 | Level 1, Level 2, Level 3 | Same |
| Fluid resistance | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | Same |
| Particulatefiltrationefficiency | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1:Ear loop (Non-sterile): ≥95%Level 2:Ear loop (Non-sterile): ≥98%Level 3:Ear loop (Non-sterile): ≥98% | Same |
| Bacterial filtrationefficiency | Level 1: ≥95%Level 2: ≥98%Level 3: ≥98% | Level 1:Ear loop (Non-sterile): ≥95%Level 2:Ear loop (Non-sterile): ≥98%Level 3:Ear loop (Non-sterile): ≥98% | Same |
| Differentialpressure | Level 1: <5 mmH2O/cm²Level 2: <6 mmH2O/cm²Level 3: <6 mmH2O/cm² | Level 1:Ear loop (Non-sterile): <5 mmH2O/cm²Level 2:Ear loop (Non-sterile): <6 mmH2O/cm²Level 3: | Same |
| Elements ofComparison | Subject Device | Predicate Device 1 | Verdict |
| Fluid resistance | Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | mmH2O/cm2Level 1: Pass at 80 mmHgLevel 2: Pass at 120 mmHgLevel 3: Pass at 160 mmHg | Same |
| Flammability | Class I | Class I | Same |
| Sterility | Non-sterile | Non sterile/Sterile | Same |
| Label/Labeling | Complied with 21 CFR part 801 | Complied with 21 CFR part 801 | Same |
| Shelf Life | 2 years | 3 years | DifferentNote 2 |
| Biocompatibility | |||
| Cytotoxicity | Under the conditions of thestudy, the proposeddevice was non-cytotoxic. | Under the conditions of the study,the proposeddevice was non-cytotoxic. | Same |
| Sensitization | Under the conditions of thestudy, the proposeddevice was non-sensitizing. | Under the conditions of the study,the proposeddevice was non-sensitizing. | Same |
| Irritation | Under the conditions of thestudy, the proposeddevice was non-irritating. | Under the conditions of the study,the proposeddevice was non-irritating. | Same |
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Comparison in Detail(s):
Note 1:
Although there are a few differences in "Design feature", "Dimension", materials of "Ear loops/headband" and "Nose Clip" of the subject device and predicate device, they all met the ASTM F2100 and ISO 10993 standards required. So, the differences between the subject device and the predicate devices will not affect the safety and effectiveness.
Note 2:
Although the "Shelf life" of the subject device is a little different from the predicate device, the performance testing of the subject device after accelerated aging has been conducted and the test results show that the subject device after the aging meets the all-performance requirements of ASTM F2100. So, the differences between the subject device and predicate device will not affect the safety and effectiveness.
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8. Summary of Non-Clinical Performance Testing
Performance Testing summary
| Pass criteria | Test | ||||
|---|---|---|---|---|---|
| Test item | Test method | ForLevel 1 | For Level2 | ForLevel 3 | results/Verdict |
| Bacterialfiltrationefficiency | ASTM F2101-19 StandardTest Method for Evaluatingthe Bacterial FiltrationEfficiency (BFE) of MedicalFace Mask Materials, Usinga Biological Aerosol ofStaphylococcus aureusaccording to ASTM F2100:2019 | ≥ 95% | ≥ 98% | ≥ 98% | Pass |
| Differentialpressure(Delta-P) | EN 14683: 2019, Annex CMedical face masks -Requirements and testmethods according toASTM F2100: 2019 | <5.0 mmH2O/cm² | <6.0 mmH2O/cm² | <6.0 mmH2O/cm² | Pass |
| Sub-micronparticulatefiltrationefficiency at0.1 µm ofPolystyreneLatex Spheres | ASTM F2299 Standard TestMethod for Determining theInitial Efficiency of MaterialsUsed in Medical FaceMasks to Penetration byParticulates Using LatexSpheres according to ASTMF2100: 2019 | ≥ 95% | ≥ 98% | ≥ 98% | Pass |
| Resistance topenetration bysyntheticblood,minimumpressure inmm Hg forpass result | ASTM F1862/F1862M-17Standard Test Method forResistance of Medical FaceMasks to Penetration bySynthetic Blood (HorizontalProjection of Fixed Volume ata Known Velocity) accordingto ASTM F2100:2019 | Pass at80 mmHg | Pass at120 mmHg | Pass at160 mmHg | Pass |
| 16 CFR Part 1610 Standardfor the Flammability ofClothing according to ASTMF2100:2019 | |||||
| Flamespread | Class 1 | Class 1 | Class 1 | Pass |
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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 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:
| Title of the test | Purpose of thetest | ReferenceforTest method | Acceptancecriteria | Testresults |
|---|---|---|---|---|
| In vitroCytotoxicity Test | Under the researchconditions.determine whetherthe target deviceextract is cytotoxic. | ISO 10993-5:2009Biological evaluationof medical devices-Part 5: Tests for invitro cytotoxicity | Under theconditions of thestudy, the subjectdevice extract wasdetermined to benon-cytotoxic. | Pass |
| SkinSensitizationTest | Under the researchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare sensitive. | ISO 10993-10:2010Biological evaluationof medical devices-Part 10: Tests forirritation and skinsensitization | Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determined tobe non-sensitizing. | Pass |
| Skin IrritationTest | Under the researchconditions,determine whetherthe non-polar andpolar extracts ofthe target deviceare irritating. | ISO 10993-10:2010Biological evaluationof medical devices-Part 23: Tests forirritation and skinsensitization | Under theconditions of thestudy, the subjectdevice non-polarand polar extractswere determined tobe non-irritating. | Pass |
9. Summary of Clinical Performance Test
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No clinical study is included in this submission.
10. Final Conclusion
The subject device is as safe, as effective, and performs as well as the legally marketed predicate device K210622.
§ 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.