(84 days)
No Reference Device(s) K/DEN number was found in the text.
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 infection control by protecting wearers from microorganisms, body fluids, and particulate material, not for treating a disease or condition.
No
The device description clearly states it is a "Surgical Mask" intended for "infection control practices to reduce the potential exposure to blood and body fluids," which indicates it is a protective barrier, not a device used to diagnose a medical condition.
No
The device description clearly outlines physical components like polypropylene layers, ear loops, and a nose clip, indicating it is a physical medical device, not software-only.
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 surgical 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 function.
- Device Description: The description details the physical construction of a mask designed for filtration and barrier protection. There are no components or mechanisms described that would perform a diagnostic test on a sample from the human body.
- Performance Studies: The performance studies focus on the physical properties of the mask related to its barrier function (fluid resistance, filtration efficiency, breathability, flammability) and biocompatibility (cytotoxicity, irritation, sensitization). There are no studies related to the detection or measurement of substances in a biological sample, which is characteristic of IVD devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
In summary, the device is a physical barrier intended for infection control, not a diagnostic tool that analyzes samples outside the body.
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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip 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 mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.
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 personnel
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 test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification for Performance of Materials Used In . Medical Face Masks.
- . ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed Volume At A Known Velocity).
- EN 14683:2019, Medical Face Mask-Requirements and Test Methods.
- . ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- . ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres.
- 16 CFR 1610, Standard for the Flammability of clothing textiles. .
Table.1 Performance testing:
- Fluid Resistance Performance (mmHg): ASTM F1862/F1862M-17, 29 out of 32 pass at 160 mmHg, Pass
- Particulate Filtration Efficiency (%): ASTM F2299-03, ≥ 98%, Pass
- Bacterial Filtration Efficiency (%): ASTM F2101-19, ≥ 98%, Pass
- Differential Pressure (Delta-P) Test (mm H2O/cm2): EN 14683:2019,
§ 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 11, 2021
Shandong Shengquan New Materials Co., Ltd. % Daniel Qiu Project Manager Shanghai Qisheng Business Consulting Co., Ltd. Room 1301, Bld 46, Jing Gu Zhong Rd. No.58, Min Hang District Shanghai, Shanghai 200240 China
Re: K211552
Trade/Device Name: Surgical mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: May 19, 2021 Received: May 19, 2021
Dear Daniel Qiu:
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.
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) K211552
Device Name Surgical mask
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 surgical masks are intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is a single use, and 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: K211552
I. Submitter
Shandong Shengquan New Materials Co.,Ltd. Diaozhen Industrial Development Zone, Zhangqiu District, Jinan, Shandong Province, China.
Telephone: +86-13864136816 Fax: 0086-400-777-8118
Contact person: Xiumei Zhang Date prepared: August 03,2021
II. Device
Name of Device: Surgical mask Model name: SMDP20608 Classification Name: surgical apparel (21 CFR 878.4040) Regulatory Class: II Product Code: FXX
III. Predicative device
510(k) Number: K201629 Name of Device: Medical Face Mask Classification Name: surgical apparel (21 CFR 878.4040) Regulatory Class: II Product code: FXX
IV. Device description
The Surgical Mask is a non-sterile, single use, and flat pleated mask with ear loops and nose clip. The product is manufactured with three layers, the inner layer is made of white polypropylene spunbond, the outer layer is made of black polypropylene spunbond (a common colorant named carbon black was added) and the middle layer is made of melt blown polypropylene filter. The elastic ear loops are not made with natural rubber latex. The nose clip in the layers of facemask is to allow the user
4
to fit the facemask around their nose, which is made of malleable polyethylene wire. The mask will be provided in black and white. The colour of outer layer is black. The colour of inner layer is white.
V. Indication 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 surgical 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, and provided non-sterile.
| Item | Subject device | Predicate device | Discussion |
|---|---|---|---|
| Product Namew | Surgical Mask | Medial Face Mask | |
| Manufacturer | Shandong Shengquan New | ||
| Materials Co., Ltd. | Shandong Shengquan | ||
| New Material Co., Ltd. | N/A | ||
| 510(k) number | K211552 | K201629 | N/A |
| Product code | FXX | FXX | Same |
| Regulation No. | 21 CFR878.4040 | 21 CFR878.4040 | Same |
| Class | Class II | Class II | Same |
| Intended 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 surgical | |||
| 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, and provided non- | |||
| sterile. | The medical 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, and | |||
| provided non-sterile. | Same | ||
| Model | Ear Loops. Flat Pleated. 3 | Ear Loops. Flat Pleated. 3 | Same |
VI. Comparison of technological characteristics with the predicate devices
5
| layers | layers | |||
|---|---|---|---|---|
| Material | Outer layer | Polypropylene spunbond | Spunbond polypropylene | Same |
| Middle | ||||
| layer | Melt blown polypropylene | |||
| filter | Melt blown polypropylene | |||
| filter | Same | |||
| Inner layer | Polypropylene spunbond | Spunbond polypropylene | Same | |
| Nose clip | Malleable polyethylene | Malleable polyethylene | Same | |
| Ear loops | Spandex, Polyester | Spandex, Polyester | Same | |
| Color | Black and White | White | Different | |
| Dimension (Length) | $17.5cm \pm 0.88cm$ | $17.5cm\pm0.88cm$ | Same | |
| Dimension (Width) | $9.5cm\pm0.48cm$ | $9.5cm\pm0.48cm$ | Same | |
| OTC use | Yes | Yes | Same | |
| Sterility | Non-sterile | Non-sterile | Same | |
| Single-use | Yes | Yes | Same | |
| ASTM F2100 Level | Level 3 | Level 2 | Different | |
| Biocompatibility | In-vitro | |||
| cytotoxicity | Conform to ISO 10993- | |||
| 5:2009 | Conform to ISO 10993- | |||
| 05:2009 | Same | |||
| Irritation | Conform to ISO 10993- | |||
| 10:2010 | Conform to ISO 10993- | |||
| 10:2010 | Same | |||
| Skin | ||||
| sensitization | Conform to ISO 10993- | |||
| 10:2010 | Conform to ISO 10993- | |||
| 10:2010 | Same |
The difference in the color and ASTM F2100 level does not raise additional questions for safety and effectiveness. Performance testing including biocompatibility evaluation was performed on the final finished device.
VII. Summary of non-clinical testing
The test results demonstrated that the proposed device complies with the following standards:
- . ISO 10993-5: 2009 Biological Evaluation Of Medical Devices -- Part 5: Tests For In Vitro Cytotoxicity.
- . ISO 10993-10: 2010 Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization.
- ASTM F2100-19, Standard Specification for Performance of Materials Used In . Medical Face Masks.
- . ASTM F1862M-17, Standard Test Method For Resistance Of Medical Face Masks To Penetration By Synthetic Blood (Horizontal Projection Of Fixed
6
Volume At A Known Velocity).
- EN 14683:2019, Medical Face Mask-Requirements and Test Methods.
- . ASTM F2101-19, Standard Test Method For Evaluating The Bacterial Filtration Efficiency (BFE) Of Medical Face Mask Materials, Using A Biological Aerosol Of Staphylococcus Aureus.
- . ASTM F2299-03, Stand test method for determining the initial efficiency of materials used in medical face masks to penetration by particulates using latex spheres.
- 16 CFR 1610, Standard for the Flammability of clothing textiles. .
| Performance
Characteristics | References for Test
Method | Acceptance Criteria | Results |
|---------------------------------------------------------|-------------------------------|----------------------------------|---------|
| Fluid Resistance
Performance
(mmHg) | ASTM
F1862/F1862M-17 | 29 out of 32 pass at
160 mmHg | Pass |
| Particulate Filtration
Efficiency (%) | ASTM F2299-03 | ≥ 98% | Pass |
| Bacterial Filtration
Efficiency (%) | ASTM F2101-19 | ≥ 98% | Pass |
| Differential Pressure
(Delta-P) Test (mm
H2O/cm2) | EN 14683:2019 |