(92 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. This is a single use device, provided non-sterile.
Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow 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 the study results for a medical surgical mask (Model: ZKM-U01). It does not pertain to an AI/ML powered device, therefore, information such as human-in-the-loop performance, effect size of AI assistance, and details about training/test set provenance are not applicable.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance:
| Test Methodology | Acceptance Criteria | Reported Device Performance | Meets Criteria? |
|---|---|---|---|
| Fluid Resistance (ASTM F1862-17) | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg | Yes |
| Particulate Filtration Efficiency (ASTM F2299-17) | ≥98% | Pass, average 99.99% | Yes |
| Bacterial Filtration Efficiency (ASTM F2101-19) | ≥98% | Pass, average > 99.8% | Yes |
| Differential Pressure (Delta P) (EN 14683:2019, Annex C and ASTM F2100-19) | <6.0 mmH2O/cm² | Pass, average 5.5 mmH2O/cm² | Yes |
| Flammability (16 CFR 1610) | Class 1 | Pass, Class I | Yes |
| In vitro cytotoxicity (ISO 10993-5) | The test article should not have potential toxicity to L-929 in the MTT method. | Pass, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method. | Yes |
| Skin sensitization (ISO 10993-10) | The test article should not cause delayed dermal contact sensitization in the guinea pig. | Pass, the test article showed no evidence of delayed dermal contact sensitization in the guinea pig. The test article Surgical face mask has no potential skin sensitization on guinea pigs in the extraction method. | Yes |
| Skin irritation (ISO 10993-10) | The irritation response category in the rabbit should be negligible. | Pass, the response of the test article extract was categorized as negligible under the test condition. The test article Surgical Face Mask has no potential skin irritation on rabbit in the extraction method. | Yes |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes used for each performance test (e.g., number of masks tested for fluid resistance). The studies were non-clinical, meaning they were conducted in a laboratory setting rather than with human patients. Data provenance is not described beyond the tests being conducted on the "Medical Surgical Mask (Model: ZKM-U01)".
3. Number of Experts Used to Establish Ground Truth and Qualifications:
Not applicable, as this is a non-clinical performance study of a physical device, not an AI/ML device requiring expert ground truth for classification or diagnosis.
4. Adjudication Method for the Test Set:
Not applicable for a non-clinical performance study of a physical device.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
Not applicable. This is not an AI-powered diagnostic device so no MRMC study was performed.
6. Standalone (Algorithm Only) Performance:
Not applicable. This is a physical medical device, not an algorithm.
7. Type of Ground Truth Used:
The ground truth for the performance tests was established by objective measurements based on internationally recognized standards and methodologies (e.g., ASTM, ISO, EN, CFR standards). For example:
- Fluid Resistance: Visual observation of penetration at a specific pressure.
- Filtration Efficiency: Measurement of particle/bacterial count before and after filtration.
- Differential Pressure: Direct measurement of pressure difference across the mask.
- Flammability: Observation of burn characteristics.
- Biocompatibility: In-vitro cell culture and in-vivo animal (guinea pig, rabbit) responses to extracts as per ISO standards.
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no training set for a physical 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, with the letters "FDA" in a blue square. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Nov 5. 2021
Guangzhou ZhengKang Medical Equipment Co.,Ltd Tracy Che Registration engineer Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China
Re: K212460
Trade/Device Name: Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm)) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: July 27, 2021 Received: August 5, 2021
Dear Tracy Che:
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 809); 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,
For Clarence W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K212460
Device Name
Medical Surgical Mask (Model: ZKM-U01(non-sterilized type 17.5cm×9.5cm))
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. This is a single use device, provided non-sterile.
| 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,Baiyun | |||
| District,GuangZhou,China | ||||
| Contact person: | Mike Wu | |||
| Phone number: | 86-13600073056 | |||
| Fax number: | / | |||
| Email: | info@zkmedical.com | |||
| Date of summary prepared: | 2021.08.02 |
(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 | Mexpo International Inc. |
|---|---|
| Device Name | Avianz® Surgical Face Mask |
| 510(k) Number | K200847 |
| Product Code | FXX |
| Regulation Number | 21 CFR 878.4040 |
| Regulation Class | II |
(5) Description/ Design of device
Medical Surgical Mask is a non-sterile, single use, three-layer mask with earloops and nose piece. The Medical Surgical Mask is manufactured with three layers, the outer and inner layers are made
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of non-woven fabric, and the middle layer is made of melt-blown fabric. The earloops are made of polyester textured yarn. The nose piece is made of polyethylene, which allow the users to adjust the nose piece according to the shape of the bridge of the nose.
(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. This is a single use device, provided non-sterile.
(7) Materials
| Component ofDevice RequiringBiocompatibility | Material of Component | Body ContactCategory(ISO 10993-1) | Contact Duration(ISO 10993-1) |
|---|---|---|---|
| Medical SurgicalMask ( ZKM-U01(non-sterilized type17.5cm×9.5cm)) | Non-woven fabric,Melt-blown fabric,Polyester textured yarn,Polyethylene | Surface-contactingdevice: skin | > 24h to 30 d |
The body-contacting material used in the Medical Surgical Mask have all passed biocompatibility test. Details can be seen in "Biocompatibility Discussion".
| Item | Proposed device | Predicate device | Remark | |
|---|---|---|---|---|
| Trade name | Medical Surgical Mask | Avianz® Surgical Face Mask | / | |
| 510 (k) number | K212460 | K200847 | / | |
| Regulation number | 21 CFR 878.4040 | 21 CFR 878.4040 | Same | |
| Regulation description | Surgical apparel | Surgical apparel | Same | |
| Product code | FXX | FXX | Same | |
| Class | II | II | Same | |
| Indications for use/ Intended 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. This is a single use device, provided non-sterile. | When properly worn, the surgical face masks are intended to protect both patient and healthcare workers from transfer of microorganisms, body fluids and airborne particles. This device is non-sterile and for single use only. | Similar, only wording difference | |
| Materials | Inner layer | Non-woven fabric | Spunbond Polypropylene | Similar |
| Middle layer | Melt-blown fabric | Melt BlownPolypropyleneFilter | Similar | |
| Outer layer | Non-woven fabric | Spunbond Polypropylene | Similar | |
| Nose piece | Polyethylene | Single Galvanize Wire,Coated By PE | Differences resolved bybiocompatibility testing | |
| Headband | Polyester textured yarn | Not made with naturalrubber latex | Differences resolved bybiocompatibility testing | |
| Mask style | Flat pleated | Flat pleated | Same | |
| Design feature | Earloop | Earloop | Same | |
| Dimensions | 17.5cm×9.5cm | (17.5cm±0.5cm)×(9.0cm± 0.5cm) | Similar | |
| Latex | Not made with naturalrubber latex | Not made with naturalrubber latex | Same | |
| Color | Blue | White | Differences resolved bybiocompatibility testing | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Use | Single use | Single use | Same | |
| Prescription or OTC | OTC | OTC | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Performance test result | ||||
| Fluid resistance | No penetration pass at 120 mmHg | 30 out of 32 pass at 120 mmHg | Similar | |
| Particle FiltrationEfficiency | Average 99.99% | 99.9% | Same | |
| Bacterial FiltrationEfficiency | Average > 99.8% | > 99.9% | Similar | |
| Flammability Class | Class 1 | Class 1 | Same | |
| Delta - P | Average 5.5 mmH2O/cm² | 3.0 mmH2O/cm² | Similar, bothmasks metrequirements of<6.0 mmH2O/cm² | |
| Biocompatibility | No cytotoxicity (ISO 10993- 5)No sensitization (ISO 10993- 10) | Non-Cytotoxic,Non-Sensitizing,Non-Irritating | Same | |
(8) Comparison to Predicate Device
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| No irritation (ISO 10993-10) | ||
|---|---|---|
| ---------------------------------- | -- | -- |
(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 the effectiveness of the test article in protecting the user from possible exposure to body fluids. | No penetration pass at 120mmHg | Pass, no penetration pass at 120mmHg |
| Particulate FiltrationEfficiency ASTMF2299-17 | To evaluate the effectiveness of the test article in protecting the user from possible exposure to particulates. | ≥98% | Pass, average 99.99% |
| Bacterial FiltrationEfficiencyASTM F2101-19 | To evaluate the bacterial filtration efficiency (BFE) of mask. | ≥98% | Pass, average > 99.8% |
| Differential Pressure(Delta P) EN14683:2019,Annex C and ASTMF2100-19 | To measure the differential pressure of mask which is related to breathability. | <6.0 mmH2O/cm² | Pass, average 5.5 mmH2O/cm² |
| Flammability 16CFR 1610 | To evaluate the flammability of mask. | Class 1 | Pass, Class I |
| In vitro cytotoxicityISO 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, the test article Surgical face mask has no potential toxicity to L-929 in the MTT method. |
| Skin sensitizationISO 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 delayed dermal contact sensitization in the guinea pig. The test article Surgical face |
| Skin irritationISO 10993-10 | To evaluate thebiological safety of theproduct which hasdirect contact withintact skin. | The irritation responsecategory in the rabbitshould be negligible. | mask has no potentialskin sensitization onguinea pigs in theextraction method. |
| Pass, the response ofthe test article extractwas categorized asnegligible under thetest condition. The testarticle Surgical FaceMask has no potentialskin irritation onrabbit in the extractionmethod. |
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(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, K200847, Avianz® Surgical Face Mask.
§ 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.