(60 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical mask, with no mention of AI or ML.
No
The device is a Medical Surgical Mask intended for protection against microorganisms and fluids, not for treating a disease or condition.
No
The device is a medical surgical mask, intended to protect against the transfer of microorganisms and fluids. It does not perform any diagnostic function.
No
The device description clearly outlines a physical, multi-layer mask made of non-woven and melt spray fabrics with ear loops and a nose piece. The performance studies are focused on physical properties like fluid resistance, filtration efficiency, and flammability, not software performance.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Intended Use: The intended use of this device is to protect against the transfer of microorganisms, body fluids, and particulate materials by being worn over the mouth and nose. It's a barrier device for infection control.
- Device Description: The description details the physical construction and materials of a mask, not a device designed to analyze biological samples.
- Performance Studies: The performance studies listed (Fluid Resistance, Filtration Efficiency, etc.) are related to the physical barrier properties and biocompatibility of the mask, not diagnostic performance metrics like sensitivity or specificity in analyzing biological samples.
The information provided clearly describes a Medical Surgical Mask, which is a personal protective equipment (PPE) device used for barrier protection, not an IVD.
N/A
Intended Use / 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 nonsterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare workers
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical studies and tests performed:
Fluid Resistance Performance (ASTM F1862-17):
- ZKM-U02 (Black): No penetration at 80mmHg
- ZKM-U03 (Blue): 31 out of 32 pass at 80mmHg
- ZKM-U04 (White): 31 out of 32 pass at 80mmHg
- ZKM-U05 (Black): No penetration at 160mmHg
- ZKM-U06 (Blue): 31 out of 32 pass at 160mmHg
- ZKM-U07 (White): 31 out of 32 pass at 160mmHg
Particulate Filtration Efficiency (ASTM F2299-17):
- Level 1: ≥96.42%
- Level 3: ≥99.89%
Bacterial Filtration Efficiency (ASTM F2101-19):
- Level 1: ≥99.6%
- Level 3: ≥99.8%
Differential Pressure (Delta P) (EN 14683:2019+AC:2019 Annex C):
- Level 1: Average 3.68 mmH2O/cm²
- Level 3: Average 3.97 mmH2O/cm²
Flammability (16 CFR 1610): Class 1
In vitro cytotoxicity (ISO 10993-5): Pass. Under the conditions of this study, the test article has no potential toxicity to L-929 cells.
Skin sensitization (ISO 10993-10): Pass. The test article showed no evidence of causing delayed dermal contact sensitization in the guinea pig.
Skin irritation (ISO 10993-10): Pass. The test article has no skin irritation on rabbits.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Fluid resistance:
- Level 1: Pass at 80mmHg
- Level 3: Pass at 160mmHg
- Particle Filtration Efficiency:
- Level 1: ≥96.42%
- Level 3: ≥99.89%
- Bacterial Filtration Efficiency:
- Level 1: ≥99.6%
- Level 3: ≥99.8%
- Flammability Class: Class 1
- Differential Pressure:
- Level 1: Average 3.68 mmH2O/cm²
- Level 3: Average 3.97 mmH2O/cm²
- Cytotoxicity: Non-cytotoxic
- Irritation: Non-irritating
- Sensitization: Non-sensitizing
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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.
1
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
2
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,Baiyun |
| District,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
4
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 Device
Requiring
Biocompatibility | Material of
Component | Body Contact
Category
(ISO 10993-1) | Contact
Duration
(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) | Polypropylene
non-woven fabric,
Polypropylene melt
spray fabric, Polyester
textured yarn,
Polyethylene | Surface-contacting
device: 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 | ||
| 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. The Medical | |||||
| Surgical Mask is intended | |||||
| for use in infection control | |||||
| practices to reduce the | |||||
| potential exposure to blood | |||||
| and body fluids. This is a | |||||
| single use, disposable | |||||
| device, provided | |||||
| non-sterile. | The Surgical Mask is | ||||
| intended to be worn to | |||||
| protect both the patient | |||||
| and healthcare personnel | |||||
| from the transfer of | |||||
| microorganisms, bodyfluids, and particulate | |||||
| material. The 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(s), provided | |||||
| non-sterile. | Same | ||||
| Materials | Outer layer | Polypropylene non-woven | |||
| fabric | polypropylene spunbond | ||||
| fabric | Similar | ||||
| Middle layer | Polypropylene melt spray | ||||
| fabric | polypropylene meltblown | ||||
| fabric | Similar | ||||
| Inner layer | Polypropylene non-woven | ||||
| fabric | polypropylene spunbond | ||||
| fabric | Similar | ||||
| Nose piece | Polyethylene | polypropylene coated | |||
| galvanized iron wire | Differences, | ||||
| resolved by | |||||
| biocompatibility | |||||
| testing | |||||
| Ear loops | Polyester textured yarn | nylon, spandex | Differences, | ||
| resolved by | |||||
| biocompatibility | |||||
| testing | |||||
| Mask style | Flat pleated | Flat pleated | Same | ||
| Design feature | Ear loops | Ear loops | Same | ||
| Dimensions | $17.5cm×9.5cm$ | 17.5 cm ±5mm | |||
| 9.5 cm±3mm | Similar | ||||
| Color | Black, Blue, White | Blue | Differences, | ||
| resolved by |
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| | | | biocompatibility
testing |
|------------------------------------|--------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------|
| 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 80mmHg
Level 3: Pass at 160mmHg | Level 1: Pass at 80mmHg
Level 2: Pass at 120mmHg
Level 3: Pass at 160mmHg | Same |
| Particle Filtration
Efficiency | Level 1: ≥96.42%
Level 3: ≥99.89% | Level 1: ≥99%
Level 2: ≥99%
Level 3: ≥99% | Similar |
| Bacterial Filtration
Efficiency | 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/cm²
Level 3:
Average 3.97 mmH2O/cm² | Level 1: