(60 days)
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. 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.
Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece. These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.
The provided text describes the acceptance criteria and performance of a Medical Surgical Mask but does not involve an AI-powered device or a study comparing AI assistance with human readers. Therefore, the questions related to AI effects, training data, and expert adjudication are not applicable.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
The device, "Medical Surgical Mask," was tested according to various standards (ASTM, EN, CFR, ISO). The results are categorized by Level 1 and Level 3 barrier requirements as per ASTM F2100.
| Test Methodology | Purpose | Acceptance Criteria | Reported Device Performance |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | To evaluate the effectiveness of the test article in protecting the user from possible exposure to body fluids. | Level 1: 80mmHg Level 3: 160mmHg | ZKM-U02 (Black) (Level 1): No penetration at 80mmHg ZKM-U03 (Blue) (Level 1): 31 out of 32 pass at 80mmHg ZKM-U04 (White) (Level 1): 31 out of 32 pass at 80mmHg ZKM-U05 (Black) (Level 3): No penetration at 160mmHg ZKM-U06 (Blue) (Level 3): 31 out of 32 pass at 160mmHg ZKM-U07 (White) (Level 3): 31 out of 32 pass at 160mmHg |
| Particulate Filtration Efficiency (ASTM F2299-17) | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | Level 1: ≥95% Level 3: ≥98% | Pass Level 1: ≥96.42% Level 3: ≥99.89% |
| Bacterial Filtration Efficiency (ASTM F2101-19) | To evaluate the bacterial filtration efficiency (BFE) of the mask. | Level 1: ≥95% Level 3: ≥98% | Pass Level 1: ≥99.6% Level 3: ≥99.8% |
| Differential Pressure (Delta P) (EN 14683:2019+AC:2019 Annex C) | To measure the differential pressure of mask which is related to breathability. | Level 1: <5.0 mmH2O/cm² Level 3: <6.0 mmH2O/cm² | Pass Level 1: Average 3.68 mmH2O/cm² Level 3: Average 3.97 mmH2O/cm² |
| Flammability (16 CFR 1610) | To evaluate the flammability of the mask. | Class 1 | Pass, Class 1 |
| In vitro cytotoxicity (ISO 10993-5) | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not have potential toxicity to L-929 in the MTT method. | Pass. Under the conditions of this study, the test article has no potential toxicity to L-929 cells. |
| Skin sensitization (ISO 10993-10) | To evaluate the biological safety of the product which has direct contact with intact skin. | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass. The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig. |
| Skin irritation (ISO 10993-10) | To evaluate the biological safety of the product which has direct contact with intact skin. | The irritation response category in the rabbit should be negligible. | Pass. The test article has no skin irritation on rabbits. |
2. Sample size used for the test set and the data provenance
- Fluid Resistance:
- For ZKM-U02 (Black) and ZKM-U05 (Black): Not explicitly stated, but implies passing for all samples tested.
- For ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U06 (Blue), ZKM-U07 (White): 32 samples were tested for each model, with 31 out of 32 passing based on the acceptance criteria.
- Other performance tests (Particulate Filtration Efficiency, Bacterial Filtration Efficiency, Differential Pressure, Flammability): The sample size for these tests is not explicitly stated in the provided text. The results are reported as overall percentages or averages.
- Biocompatibility tests (Cytotoxicity, Skin Sensitization, Skin Irritation): Sample sizes are not explicitly stated for these tests, though they typically involve a specific number of cells (cytotoxicity) or animals (sensitization/irritation).
- Data Provenance: The study is "non-clinical" and likely conducted in a laboratory setting. The country of origin for the data is not specified beyond the manufacturer's location in Guangzhou, China. The studies are assumed to be prospective tests performed on the manufactured devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert interpretation of results to establish ground truth (e.g., medical imaging diagnosis). The ground truth is established by objective measurements against standardized test methodologies (e.g., ASTM, ISO).
4. Adjudication method for the test set
Not applicable. There's no human interpretation or subjective assessment that would require an adjudication method. The tests are objective measurements.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a medical surgical mask, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical product, not an algorithm.
7. The type of ground truth used
The ground truth is based on objective measurements against established international and national standards and methodologies, such as ASTM F1862-17 for fluid resistance, ASTM F2299-17 for particulate filtration efficiency, ASTM F2101-19 for bacterial filtration efficiency, EN 14683:2019+AC:2019 Annex C for differential pressure, 16 CFR 1610 for flammability, and ISO 10993 series for biocompatibility.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image contains 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
September 23, 2022
Guangzhou ZhengKang Medical Equipment Co., Ltd % Riley Chen Registration Engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 ZhenYe International Center, No. 3101-90 Oianhai Road, Nanshan District Shenzhen, Guangdong 518000 China
Re: K222204
Trade/Device Name: Medical Surgical Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: July 5, 2022 Received: July 25, 2022
Dear Riley Chen:
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.
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) K22204
Device Name Medical Surgical Mask
Indications for Use (Describe)
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. 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 nonsterile.
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
This "510(k) Summary" of 510(k) safety and effectiveness information is submitted in accordance with requirements of Title 21, CFR Section 807.92.
(1) Applicant information
| 510 (k) owner's name: | Guangzhou ZhengKang Medical Equipment Co.,Ltd |
|---|---|
| Address: | Room101,No.9Nanling Zhongxin Kuang Road,Taihe Town,BaiyunDistrict,GuangZhou,China |
| Contact person: | Mike Wu |
| Phone number: | 86-13600073056 |
| Fax number: | / |
| Email: | info@zkmedical.com |
| Date of summary prepared: | 2022-9-22 |
(2) Reason for the submission
New device, there were no prior submissions for the device.
(3) Proprietary name of the device
| Trade name: | Medical Surgical Mask |
|---|---|
| Regulation Name: | Surgical apparel |
| Regulation number: | 21 CFR 878.4040 |
| Product code: | FXX |
| Review panel: | General & Plastic Surgery |
| Regulation class: | Class II |
(4) Predicate device
| Sponsor | Jiangmen Ningrui Medical Supplies Co., Ltd. |
|---|---|
| Device Name | Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A) |
| 510(k) Number | K212293 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |
(5) Description/ Design of device
Medical Surgical Mask includes 6 models, which are ZKM-U02 (Black), ZKM-U03 (Blue), ZKM-U04 (White), ZKM-U05 (Black), ZKM-U06 (Blue), ZKM-U07 (White). The Medical
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Surgical Mask is a non-sterile, single use, three-layer mask with ear loops and nose piece.
These 6 models of Medical Surgical Mask share the same structure and they are manufactured with three layers, the outer and inner layers are made of polypropylene non-woven fabric, and the middle layer is made of polypropylene melt spray fabric. The Medical Surgical Mask is held in place over the user's mouth and nose by two ear loops made of polyester textured yarn. The nose piece is made of polyethylene, which allows the users to adjust the nose piece according to the shape of the bridge of the nose.
The model ZKM-U02 (Black) is Level 1 barrier as ASTM F2100 requirements.
The model ZKM-U03 (Blue) is Level 1 barrier as ASTM F2100 requirements.
The model ZKM-U04 (White) is Level 1 barrier as ASTM F2100 requirements.
The model ZKM-U05 (Black) is Level 3 barrier as ASTM F2100 requirements.
The model ZKM-U06 (Blue) is Level 3 barrier as ASTM F2100 requirements.
The model ZKM-U07 (White) is Level 3 barrier as ASTM F2100 requirements.
(6) Indications for use
Medical Surgical Mask is intended to be worn to protect both patients and healthcare workers against transfer of microorganisms, body fluids and particulate materials. 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.
| Component of DeviceRequiringBiocompatibility | Material ofComponent | Body ContactCategory(ISO 10993-1) | ContactDuration(ISO 10993-1) |
|---|---|---|---|
| Medical Surgical Mask,Model: ZKM-U02 (Black),ZKM-U03 (Blue),ZKM-U04 (White),ZKM-U05 (Black),ZKM-U06 (Blue),ZKM-U07 (White) | Polypropylenenon-woven fabric,Polypropylene meltspray fabric, Polyestertextured yarn,Polyethylene | Surface-contactingdevice: skin | > 24h to 30 d |
(7) Materials
The body-contacting material used in the Medical Surgical Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".
(8) Comparison to Predicate Device
| Item | Proposed device | Predicate device | Remark |
|---|---|---|---|
| Trade name | Medical Surgical Mask | Surgical Mask (Model:WK1701-02A, | / |
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Guangzhou ZhengKang Medical Equipment Co.,Ltd
510(k)s – Section 8. 510 (k) Summary
| 510(k) - Section 510 (k) Summary | |||||
|---|---|---|---|---|---|
| WK1701-03A,WK1701-04A) | |||||
| 510 (k) number | K212293 | / | |||
| Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | ||
| Regulationdescription | Surgical apparel | Surgical apparel | Same | ||
| Product code | FXX | FXX | Same | ||
| Class | II | II | Same | ||
| Indications for use/Intended use | Medical Surgical Mask isintended to be worn toprotect both patients andhealthcare workers againsttransfer of microorganisms,body fluids and particulatematerials. The MedicalSurgical Mask is intendedfor use in infection controlpractices to reduce thepotential exposure to bloodand body fluids. This is asingle use, disposabledevice, providednon-sterile. | The Surgical Mask isintended to be worn toprotect both the patientand healthcare personnelfrom the transfer ofmicroorganisms, bodyfluids, and particulatematerial. The SurgicalMask is intended for use ininfection control practicesto reduce the potentialexposure to blood andbody fluids. This is asingle-use, disposabledevice(s), providednon-sterile. | Same | ||
| Materials | Outer layer | Polypropylene non-wovenfabric | polypropylene spunbondfabric | Similar | |
| Middle layer | Polypropylene melt sprayfabric | polypropylene meltblownfabric | Similar | ||
| Inner layer | Polypropylene non-wovenfabric | polypropylene spunbondfabric | Similar | ||
| Nose piece | Polyethylene | polypropylene coatedgalvanized iron wire | Differences,resolved bybiocompatibilitytesting | ||
| Ear loops | Polyester textured yarn | nylon, spandex | Differences,resolved bybiocompatibilitytesting | ||
| Mask style | Flat pleated | Flat pleated | Same | ||
| Design feature | Ear loops | Ear loops | Same | ||
| Dimensions | $17.5cm×9.5cm$ | 17.5 cm ±5mm9.5 cm±3mm | Similar | ||
| Color | Black, Blue, White | Blue | Differences,resolved by |
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| biocompatibilitytesting | |||
|---|---|---|---|
| Sterility | Non-sterile | Non-sterile | Same |
| Use | Single use | Single use | Same |
| Prescription or OTC | OTC | OTC | Same |
| ASTM F2100 Level | Level 1, Level 3 | Level 1, Level 2, Level 3 | Same |
| Performance test result | |||
| Fluid resistance | Level 1: Pass at 80mmHgLevel 3: Pass at 160mmHg | Level 1: Pass at 80mmHgLevel 2: Pass at 120mmHgLevel 3: Pass at 160mmHg | Same |
| Particle FiltrationEfficiency | Level 1: ≥96.42%Level 3: ≥99.89% | Level 1: ≥99%Level 2: ≥99%Level 3: ≥99% | Similar |
| Bacterial FiltrationEfficiency | Level 1: ≥99.6%Level 3: ≥99.8% | Level 1: ≥99%Level 2: ≥99%Level 3: ≥99% | Similar |
| Flammability Class | Class 1 | Class 1 | Same |
| Differential Pressure | Level 1:Average 3.68 mmH2O/cm²Level 3:Average 3.97 mmH2O/cm² | Level 1: <3.4 mmH2O/cm²Level 2: <3.5 mmH2O/cm²Level 3: <3.4 mmH2O/cm² | Similar |
| Biocompatibility | |||
| Cytotoxicity | Non-cytotoxic | Non-cytotoxic | Same |
| Irritation | Non-irritating | Non-irritating | Same |
| Sensitization | Non-sensitizing | Non-sensitizing | Same |
(9) Non-clinical studies and tests performed
The following performance tests of Medical Surgical Mask were conducted:
| Test Methodology | Purpose | Acceptance criteria | Results |
|---|---|---|---|
| Fluid ResistancePerformanceASTM F1862-17 | To evaluate theeffectiveness of the testarticle in protecting theuser from possibleexposure to body fluids. | Level 1: 80mmHgLevel 3: 160mmHg | ZKM-U02 (Black): Nopenetration at 80mmHgZKM-U03 (Blue): 31 out of 32pass at 80mmHgZKM-U04 (White): 31 out of32 pass at 80mmHgZKM-U05 (Black): Nopenetration at 160mmHgZKM-U06 (Blue): 31 out of 32pass at 160mmHgZKM-U07 (White): 31 out of32 pass at 160mmHg |
| Particulate FiltrationEfficiencyASTM F2299-17 | To evaluate theeffectiveness of the testarticle in protecting theuser from possibleexposure to particulates. | Level 1: ≥95%Level 3: ≥98% | Pass,Level 1: ≥96.42%Level 3: ≥99.89% |
| Bacterial FiltrationEfficiencyASTM F2101-19 | To evaluate thebacterial filtrationefficiency (BFE) ofmask. | Level 1: ≥95%Level 3: ≥98% | Pass,Level 1: ≥99.6%Level 3: ≥99.8% |
| Differential Pressure(Delta P)EN 14683:2019+AC:2019 Annex C | To measure thedifferential pressure ofmask which is related tobreathability. | Level 1: <5.0 mmH2O/cm²Level 3: <6.0 mmH2O/cm² | Pass,Level 1: Average 3.68 mmH2O/cm²Level 3: Average 3.97 mmH2O/cm² |
| Flammability16 CFR 1610 | To evaluate theflammability of mask. | Class 1 | Pass, Class 1 |
| In vitro cytotoxicityISO 10993-5 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The test articleshould not havepotential toxicity toL-929 in the MTTmethod. | Pass. Under the conditions ofthis study, the test article hasno potential toxicity to L-929cells. |
| Skin sensitizationISO 10993-10 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The test articleshould not causedelayed dermalcontact sensitizationin the guinea pig. | Pass. The test article showedno evidence of causing delayeddermal contact sensitization inthe guinea pig |
| Skin irritationISO 10993-10 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin | The irritationresponse category inthe rabbit should benegligible. | Pass. The test article has noskin irritation on rabbits. |
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Guangzhou ZhengKang Medical Equipment Co.,Ltd 510(k)s – Section 8. 510 (k) Summary
(10) Conclusion
Based on the nonclinical tests performed, the subject device, Medical Surgical Mask, is as safe, as effective, and performs as well as the legally marketed predicate device, K212293, Surgical Mask (Model: WK1701-02A, WK1701-03A, WK1701-04A).
§ 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.