(236 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 surgical mask intended for protection against transfer of microorganisms and fluids, not for treating a disease or condition.
No
The device is a surgical mask intended for protection against the transfer of microorganisms, body fluids, and particulate material, not for diagnosing medical conditions. The performance studies focus on protective capabilities (filtration, fluid resistance) rather than diagnostic accuracy.
No
The device description clearly outlines physical components (polypropylene fabric, nose clip, ear loops) and performance testing related to material properties and physical barriers, indicating it is a hardware device. There is no mention of software functionality.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the masks are for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a barrier function, not a diagnostic one.
- Device Description: The description details the physical construction of a surgical mask, which is a physical barrier.
- Performance Studies: The performance studies focus on the physical properties and filtration capabilities of the mask (fluid resistance, particulate filtration, bacterial filtration, breathability, flammability, biocompatibility). These are relevant to its function as a barrier, not to diagnosing a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing samples from the human body (like blood, urine, tissue, etc.) or providing information about a person's health status or condition.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This surgical mask does not perform any of these functions.
N/A
Intended Use / Indications for Use
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip.
Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
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
Not Found
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 tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with ASTM F2100 and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004.
Key results from performance testing comparison:
Fluid Resistance ASTM F1862: Proposed device 32 out of 32 pass at 120 mmHg, 3 lots; Predicate device 32 out of 32 pass at 120 mmHg. Acceptance Criteria: 29 out of 32 pass at 120 mmHg. Similar results.
Particulate Filtration Efficiency ASTM F2299: Proposed device Pass at 98.1%; Predicate device Pass at 98.46%. Acceptance Criteria: ≥ 98%. Similar results.
Bacterial Filtration Efficiency ASTM F2101: Proposed device Pass at 99.9%; Predicate device Pass at 98.7%. Acceptance Criteria: ≥ 98%. Similar results.
Differential Pressure (Delta P) EN 14683 Annex C: Proposed device Pass at 4.7, 4.9, 4.7 mmH2O/cm²; Predicate device Pass at 4.2mmH2O/cm². Acceptance Criteria:
§ 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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March 29, 2021
Wuhan Zonsen Medical Products Co., Ltd % Ivy Wang Technical Manager Shanghai Sungo Management Consulting Company Limited 13th Floor, 1500# Central Avenue Shanghai, Shanghai 200122 China
Re: K202191
Trade/Device Name: Surgical Mask (Model: ZSFM 21, barrier level 2, blue) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: February 23, 2021 Received: February 26, 2021
Dear Ivy Wang:
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 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, Ph.D. 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
2
Indications for Use
510(k) Number (if known) K202191
Device Name Surgical Mask Model: ZSFM 21, barrier level 2, blue
Indications for Use (Describe)
The Surgical Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), 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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3
510(K) Summary
K202191
Date of Summary prepared: 2021-02-22
A. Applicant:
Wuhan Zonsen Medical Products Co., Ltd Address: Chengbei Industry Zone, Zhucheng Avenue, Xinzhou District, Wuhan City, Hubei Contact Person: Shirly Xi Tel: +86-15827495791 Fax: +86-27-82737771 Email: xixl@zonsenmed.com
Submission Correspondent: Primary contact: Ms. Ivy Wang Shanghai SUNGO Management Consulting Co., Ltd. Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-58817802 Email: haiyu.wang@sungoglobal.com Secondary contact: Mr. Raymond Luo Room 1309, Dongfang Building, 1500# Century Ave., Shanghai 200122, China Tel: +86-21-68828050 Email: fda.sungo@gmail.com
B. Device:
Trade Name: SURGICAL MASK Common Name: SURGICAL FACE MASK Model: ZSFM 21, barrier level 2, blue
Regulatory Information Classification Name: Surgical Face Mask Classification: Class II Product code: FXX Regulation Number: 878.4040 Review Panel: Surgical Apparel
C. Predicate device:
K153496 Disposable Surgical Face Mask Xiantao Rayxin Medical Products Co., Ltd.
4
D. Indications for use of the device:
The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile.
E. Device Description:
The Surgical Masks are single use, three-layer, flat-pleated masks with ear loops and nose clip.
Two layers of polypropylene non-woven fabric, with a layer of polypropylene melt-blown filter cloth in the middle; plastic nose clip, ear loop is spandex elastic belt.
The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the mask. The elastic ear loops are not made with natural rubber latex.
The nose clip in the layers of mask is to allow the user to fit the mask around their nose, which is made of malleable polyethylene wire.
The surgical masks will be provided in blue. The surgical masks are sold non-sterile and are intended to be single use, disposable devices.
F. Comparison with predicate device
Table 1 General Comparison
| Device | Proposed Device | Predicate Device | Result |
|---|---|---|---|
| Manufacturer | Wuhan Zonsen Medical Products Co., Ltd | Xiantao Rayxin Medical Products Co., ltd. | - |
| 510K number | K202191 | K153496 | - |
| Model Name | SURGICAL MASK | SURGICAL FACE MASK | Similar |
| Classification | Class II Device, FXX (21 CFR878.4040) | Class II Device, FXX (21 CFR878.4040) | Same |
| Intend use | The surgical masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile. | The Disposable Surgical Face Masks are intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. These face 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(s), provided non-sterile. | Same |
| Design feature | Ear Loops, Flat Pleated, 3 layers | Ear Loops, Tie-On, Flat Pleated, 3 layers | Similar |
| Material | Outer facing | ||
| Spun-bond polypropylene | Spun-bond polypropylene | Same |
5
| layer | ||||
|---|---|---|---|---|
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same | |
| Inner facing layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose clamp | Malleable polyethylene wire | Malleable aluminum wire | Different | |
| Ear loops | Spandex | Polyester | Different | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 17.5cm±1cm | 17.5cm±1cm | Same | |
| Dimension (Width) | 9.5cm±1cm | 9.5cm±1cm | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Use | Single Use, Disposable | Single Use, Disposable | Same | |
| ASTM F2100 Level | Level 2 | Level 2 | Same | |
| Biocompatibility | ISO10993 | ISO10993 | Same |
G. Summary of Technological Characteristics
Non-clinical tests were conducted to verify that the proposed device met all design specifications as was similar to the predicate device. The test results demonstrated that the proposed device complies with ASTM F2100 and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks – Premarket Notification [510(k)] Submission issued on March 5, 2004. Table 2 shows the comparison of performance testing between subject surgical masks and predicate surgical face mask. Table 3 shows the comparison of biocompatibility between subject surgical masks and predicate surgical face mask.
| Item | Proposed device
(K202191) | Predicate device
(K153496) | Acceptance Criteria
(level 2) | Result |
|--------------------------------------------------------|------------------------------------------|----------------------------------|----------------------------------|---------|
| Fluid Resistance
Performance
ASTM F1862 | 32 out of 32 pass at
120 mmHg, 3 lots | 32 out of 32 pass at
120 mmHg | 29 out of 32 pass at
120 mmHg | Similar |
| Particulate
Filtration
Efficiency ASTM
F2299 | Pass at 98.1% | Pass at 98.46% | ≥ 98% | Similar |
| Bacterial Filtration
Efficiency ASTM
F2101 | Pass at 99.9% | Pass at 98.7% | ≥ 98% | Similar |
| Differential
Pressure (Delta P)
EN 14683 Annex C | Pass at 4.7, 4.9, 4.7
mmH2O/cm² | Pass at
4.2mmH2O/cm² |