(167 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a surgical face mask, with no mention of AI or ML.
No
The device is a surgical face mask intended to protect against transfer of microorganisms and fluids, not to treat or cure a disease or condition.
No
Explanation: The "Intended Use / Indications for Use" section states the device is intended to protect the patient and healthcare personnel from transfer of microorganisms, body fluids, and particulate material, and for use in infection control practices. It does not mention diagnosis of any condition.
No
The device description clearly outlines a physical, three-layer face mask made of nonwoven and melt blown fabrics with a nose piece and tie-ons. It undergoes physical performance testing (filtration, pressure, blood penetration, flame spread) and biocompatibility testing, which are characteristic of hardware medical devices, not software.
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 mask is for protecting both the patient and healthcare personnel from the transfer of microorganisms, body fluids, and particulate material. This is a physical barrier function, not a diagnostic test performed in vitro (outside the body).
- Device Description: The description details the physical construction of the mask (layers, materials, tie-on, nose piece). There is no mention of reagents, assays, or any components used for analyzing biological samples.
- Performance Studies and Key Metrics: The performance studies focus on the mask's barrier properties (filtration efficiency, resistance to penetration by synthetic blood, flame spread). These are relevant to its function as a physical barrier, not to the accuracy of a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This surgical face mask does not perform any of these functions.
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. It 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.
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 tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. 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
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)
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
Performance:
Bacterial filtration efficiency (BFE) (%): >98%
Different pressure (mmH2O/cm²): 98%
Resistance to penetration by synthetic blood, Minimum pressure in mmHg for pass result: 31 of 32 test articles passed at 160mmHg
Flame spread: Class 1
Biocompatibility Testing:
Cytotoxicity: Under the conditions of the study, the device is noncytotoxic.
Irritation: Under the conditions of the study, the device is nonirritating.
Sensitization: Under the conditions of the study, the device is nonsensitizing.
No clinical study implemented for the Disposable Surgical Face Mask.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Bacterial filtration efficiency (BFE): >98%
Sub-micron particulate filtration efficiency (PFE at 0.1 micron): >98%
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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July 28, 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: K210409
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 20, 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.
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 Murray 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) K210409
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. It 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 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K210409 510(k) Summary
510k number: K210409 Date: July 26, 2021 This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and 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 Device information
Trade name: Disposable Surgical Face Mask Common name: Surgical mask Classification name: Mask, Surgical Model(s): ZS-S, tie-on.
3.0 Classification
Production code: FXX Regulation number: 21CFR 878.4040 Classification: Class II Panel: Surgical apparel
4.0 Predicate device information
Manufacturer: Xiantao Rayxin Medical Products Co., Ltd. Device: Disposable Surgical Face Mask 510(k) number: K153496
4
5.0 Indication for Use Statement
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. It 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.
6.0 Device description
The Disposable Surgical Face Mask is single use, three-layer, flat-pleated style with tie on and nose piece. The mask is manufactured with three layers, the inner and outer layers, and the tie on are made of nonwoven fabrics, and the middle layer is made of melt blown fabrics. During use, the tie on shall be tied over user head. 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.
| Item | Specification(cm) | Tolerance(cm) |
|---|---|---|
| Length (L) x Width (H) | 17.5cm×9.5cm | ±5% |
| 17.5cm×9.0cm | ||
| 17.0cm×9.0cm | ||
| 14.5cm×9.5cm | ||
| Nose Piece Length | 10.5cm×0.3cm | ±5% |
| Ties | 40cm×1.0cm | ±5% |
The specification of the device as follows:
7.0 Technological Characteristic Comparison Table
| Table 1 - General Comparison | ||||
|---|---|---|---|---|
| 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 Surgical Face Mask | - | |
| 510(k) No. | K210409 | K153496 | - | |
| Models | ZS-S, Tie-on. | Tie on, ear-loop, Flat Pleated, 3 layers | - | |
| Specification | 17.5cm×9.5cm | 17.5cm×9.5cm | - | |
| 17.5cm×9.0cm | ||||
| 17.0cm×9.0cm | ||||
| 14.5cm×9.5cm | ||||
| Intended Use | The Disposable Surgical | The Surgical Face Masks | Same | |
| Face Mask is intended to be | ||||
| worn to protect both the | ||||
| patient and healthcare | ||||
| personnel from transfer of | ||||
| microorganisms, body fluids | ||||
| and particulate material. It 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. | 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. | ||||
| OTC use | Yes | Yes | Same | |
| Composite | Flat Pleated, 3 layers | Flat Pleated, 3 layers | 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 | |||
| wire | Same | |||
| Tie-on | Spun-bond polypropylene | Spun-bond polypropylene | Same | |
| Color | Blue | Blue | Same | |
| Dimension (Length) | 17.5cm×9.5cm, ±5% | 17.5cm×9.5cm, ±1cm | * Gap 1 | |
| 17.5cm×9.0cm, ±5% | ||||
| 17.0cm×9.0cm, ±5% | ||||
| 14.5cm×9.5cm, ±5% | ||||
| Sterility | Non-Sterile | Non-Sterile | Same | |
| Single Use | Yes | Yes | Same | |
| Sterile | No | No | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | * Gap 2 | |
| Shelf life | 2 years | No shelf life claimed | * Gap 3 | |
| Biocompatibility | ||||
| Cytotoxicity | Under the conditions of the | |||
| study, the subject device was | ||||
| non-cytotoxic | Under the conditions of the | |||
| study, the predicate device | ||||
| was non-cytotoxic | Same | |||
| Irritation | Under the conditions of the | |||
| study, the subject device was | ||||
| non-irritating | Under the conditions of the | |||
| study, the predicate device | ||||
| was non-irritating | Same | |||
| Sensitization | Under the conditions of the | |||
| study, the subject device was | ||||
| non-sensitization | Under the conditions of the | |||
| study, the predicate device | ||||
| was non-sensitization | Same |
5
- Gap analysis:
Gap 1: the proposed device has 4 specifications, with lower dimension tolerance than the predicate device, the different specifications does not impact the surgical mask
6
performance and safety, considering the stricter tolerance of proposed device, the difference does not bring additional risks to the device.
Gap 2: the proposed device has higher performance level (Level 3) higher than the predicate device, the higher performance does not bring additional risks to the device. Gap 3: the predicate device does not claim specific shelf life while the proposed device define its 2 years shelf life which is proved by its shelf life performance study, the clear shelf life does not bring additional risks to the product use.
8.0 Summary of Non-Clinical Testing
The proposed device was tested and conformed to the related recognized standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission issued on March 5, 2004.
| Items | Performance | Acceptance Criteria
(Level 3, ASTM
F2100-19) | Result |
|-------------------------------------------------------------------------------------------------|---------------------------------------------|----------------------------------------------------|--------|
| Bacterial filtration
efficiency (BFE) (%) | >98% | ≥98 | Pass |
| Different pressure
(mmH2O/cm²) | 98% | ≥98 | Pass |
| Resistance to penetration
by synthetic blood,
Minimum pressure in
mmHg for pass result | 31 of 32 test articles
passed at 160mmHg | 29 of 32 test articles
passed at 160mmHg | Pass |
| Flame spread | Class 1 | Class 1 | Pass |
Table 3 - Biocompatibility Testing
| Item | Proposed Device | Result |
|---|---|---|
| Cytotoxicity | Under the conditions of the study, the device is noncytotoxic. | Pass |
| Irritation | Under the conditions of the study, the device is nonirritating. | Pass |
| Sensitization | Under the conditions of the study, the device is nonsensitizing. | Pass |
Biocompatibility Testing According to ISO 10993-1:2009, the nature of body contact ● for the subject device is Surface Device category, Skin Contact and duration of contact is A-Limited (≤24h). The following tests for the subject device were conducted to demonstrate that the subject device is biocompatible and safe for its intended use: 1) In vitro Cytotoxicity Test per ISO 10993-5:2009 Biological evaluation of medical devices- Part 5: Tests for in vitro cytotoxicity,
-
Skin Sensitization Tests per ISO 10993-10:2010 Biological evaluation of medical devices- Part 10: Tests for irritation and skin sensitization,
-
Skin Irritation Tests per ISO 10993-10:2010 Biological evaluation of medical
7
devices— Part 10: Tests for irritation and skin sensitization.
9.0 Clinical Test Conclusion
No clinical study implemented for the Disposable Surgical Face Mask.
10.0 Conclusion
The conclusion drawn from the nonclinical tests demonstrates that the subject device in 510(K) submission K210409, the Disposable Surgical Face Mask is as safe, as effective, and performs as well as or better than the legally marketed predicate device cleared under K153496.