(154 days)
Not Found
No
The device description and performance testing focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is described as a protective barrier (face mask) to prevent the transfer of microorganisms and fluids, not to directly treat or cure a disease or condition.
No
A surgical face mask is a protective barrier, not a tool for diagnosing medical conditions. The performance studies listed confirm its protective capabilities (e.g., filtration, fluid resistance) rather than diagnostic accuracy.
No
The device description clearly outlines physical components (three layers of fabric, ear-loops, nose piece) and performance testing relates to physical properties (filtration efficiency, fluid resistance, flammability), indicating it is a physical medical device, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. They are used outside the body (in vitro).
- This Device's Function: The Disposable Surgical Face Mask is a physical barrier worn on the face. Its purpose is to filter air and prevent the transfer of microorganisms, body fluids, and particulate material between individuals. It does not analyze any biological specimens.
- Intended Use: The intended use clearly states its purpose is for protection and infection control by being worn on the face.
- Device Description: The description details the physical construction of the mask, not any components for analyzing biological samples.
- Performance Studies: The performance studies focus on the mask's physical filtration capabilities and resistance to fluids, not on the accuracy of diagnosing or monitoring a medical condition based on biological samples.
Therefore, based on the provided information, the Disposable Surgical Face Mask is a medical device, but it falls under the category of a personal protective equipment (PPE) or a barrier device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face 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.
The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is 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
healthcare workers and patients involved in medical and surgical procedures.
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 Performance Testing:
- ASTM F2101-19 Standard Test Method for Evaluating the Bacterial Filtration: 3 lots tested with total 96 samples, 94/96 Passed at ≥98%/Pass.
- EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019: 3 lots tested with total 96 samples, 92/96 Passed
§ 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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August 4, 2021
Shandong Zhushi Pharmaceutical Group Co., Ltd % Boyle Wang General Manager Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738, Shangcheng Rd., Pudong Shanghai, Shanghai 200120 China
Re: K210643
Trade/Device Name: Disposable Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 21, 2021 Received: June 28, 2021
Dear Boyle 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.
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
1
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 and Part 809 ); medical device reporting (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,
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
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Indications for Use
510(k) Number (if known) K210643
Device Name Disposable Surgical Face Mask
Indications for Use (Describe)
The Disposable Surgical Face Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This face 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 201 Subpart D) | Over-The-Counter Use (21 CFR 201 Subpart C) |
_ | Prescription Use (Part 21 CFR 801 Subpart D)
|_ | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
510k number: K210643 Date: July 26, 2021 This summary of 510(k) is being submitted in accordance with requirements of 21 CFR 807.92.
1.0 Submitter's information
Name: Shandong Zhushi Pharmaceutical Group Co., Ltd Address: No.6 Shande Road, Shan County, Heze City, Shandong, China Contact: Mr. Junhui Zhu Phone Number: 86-530-7150111 Fax number: 86-530-7150111 Date of Preparation: Jul.26, 2021 Email: 2307426957@gq.com
Designated Submission Correspondent
Mr. Boyle Wang Shanghai Truthful Information Technology Co., Ltd. Room 608, No. 738 Shangcheng Rd., Pudong Shanghai, 200120 China Tel: +86-21-50313932 Email: Info@truthful.com.cn
2.0 Subject Device information
Type of 510(k): Traditional Trade name: Disposable Surgical Face Mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): ZS-B, ear-loop.
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Guangdong Haiou Medical Apparatus Co., Ltd.
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Device: Disposable Medical Surgical Face Mask 510(k) number: K203200 Classification name: Mask, Surgical Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
5.0 Device description
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with ear-loop and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the ear-loop is made of spandex and polyester, and the middle layer is made of melt blown fabrics. During use, the ear-loop shall be tied over user ear. The nose piece in the layers of facemask is to allow the user to fit the facemask around their nose, which is made of malleable polyethylene wire. The Disposable Surgical Face Mask is provided in blue color. The mask is sold non-sterile and are intended to be single use, disposable devices.
6.0 Indication for Use Statement
The Disposable Surgical Face Mask is indicated as a protective nose and mouth covering for healthcare workers and patients involved in medical and surgical procedures. The masks are indicated in any procedure or situation where there is a risk of exposure to microorganisms and body fluids.
7.0 Technological Characteristic Comparison
Provided below is a comparison of the proposed device with the predicate device.
| Item | Proposed device | Predicated device | Remark |
|---|---|---|---|
| Product Code | FXX | FXX | Same |
| Regulation No. | 21 CFR 878.4040 | 21 CFR 878.4040 | Same |
| Class | II | II | Same |
| Product name | Disposable Surgical Face Mask | Disposable Medical Surgical Face Mask | Same |
| 510(k) No. | K210643 | K203200 | Different |
| Models | ZS-B, ear-loop. | HO-KZ01 | Different |
| Composite | Flat Pleated, 3 layers | Ear loop, flat pleated, 3 layers | Same |
| Specification | 17.5cm×9.5cm | ||
| 17.5cm×9.0cm | 17.5cm×9.5cm | Different |
| Table 3 - General Comparison | |
|---|---|
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| 17.0cm×9.0cm | |||||
|---|---|---|---|---|---|
| 14.5cm×9.5cm | |||||
| Intended Use | The Disposable Surgical | ||||
| Face Mask is indicated as a | |||||
| protective nose and mouth | |||||
| covering for healthcare | |||||
| workers and patients involved | |||||
| in medical and surgical | |||||
| procedures. The masks are | |||||
| indicated in any procedure or | |||||
| situation where there is a risk | |||||
| of exposure to | |||||
| microorganisms and body | |||||
| fluids. | Disposable Medical Surgical | ||||
| Face Mask is indicated as a | |||||
| protective nose and mouth | |||||
| covering for healthcare | |||||
| workers and patients involved | |||||
| in medical and surgical | |||||
| procedures. The masks are | |||||
| indicated in any procedure or | |||||
| situation where there is a risk | |||||
| of exposure to | |||||
| microorganisms and body | |||||
| fluids. | Same | ||||
| OTC use | Yes | Yes | Same | ||
| Internal layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | ||
| Middle layer | Melt blown polypropylene | Melt blown polypropylene | Same | ||
| Mat | |||||
| erial | External layer | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Nose piece | Malleable polyethylene | ||||
| wire | Malleable polyethylene | ||||
| with aluminum wire | Same | ||||
| Ear-loop | spandex +polyester | polyester | Similar | ||
| Color | Blue | Blue | Same | ||
| 17.5cm×9.5cm, ±5% | |||||
| 17.5cm×9.0cm, ±5% | W: 17.5cm | Different | |||
| Dimension (W×L) | 17.0cm×9.0cm, ±5% | L: 9.5cm | |||
| 14.5cm×9.5cm, ±5% | |||||
| Sterility | Non-Sterile | Non-Sterile | Same | ||
| Single Use | Yes | Yes | Same | ||
| Sterile | No | No | Same | ||
| Fluid Resistance | |||||
| Performance | 31/32 Passed at 160mmHg | ||||
| Level 3 ASTM F1862-17 | Level 3: 160 mmHg | Same | |||
| Particulate Filtration | |||||
| Efficiency | 32/32 Passed ≥98% | ||||
| ASTMF2299-03 | ≥98% | Same | |||
| Bacterial Filtration | |||||
| Efficiency | 32/32 Passed at ≥98% | ||||
| ASTM F2101-19 | ≥98% | Same | |||
| Differential Pressure | 32/32 Passed at |