(312 days)
Not Found
No
The device description and performance testing focus solely 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 to prevent the transfer of microorganisms, body fluids, and particulate material, not to treat or diagnose a disease or condition.
No
The device is a disposable surgical mask intended to provide protection from the transfer of microorganisms, body fluids, and particulate material. It is a barrier device for protection, not a tool for diagnosing medical conditions.
No
The device description clearly outlines a physical product made of materials like polypropylene and aluminum wire, and the performance studies focus on physical properties like filtration efficiency and resistance to penetration. There is no mention of software components.
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 surgical patient and operating room 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 and materials of the mask. There is no mention of components designed to analyze biological samples or provide diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (filtration efficiency, pressure resistance, fluid resistance, flammability, biocompatibility). These are relevant to its function as a protective barrier, not as a diagnostic tool.
- Key Metrics: The key metrics are related to the mask's performance as a barrier (filtration, pressure, resistance, flammability). There are no metrics related to diagnostic accuracy (sensitivity, specificity, etc.).
An In Vitro Diagnostic device is defined as a medical device that is used to perform tests on samples such as blood, urine, or tissues to detect diseases or other conditions. This surgical mask does not perform any such tests.
N/A
Intended Use / Indications for Use
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
Product codes
FXX
Device Description
The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose.
The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.
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
Operating room personnel during 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
Non-Clinical Performance Testing:
- Bacterial filtration efficiency:
- Test method: ASTM F2101-14 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of Medical Face Mask Materials, Using a Biological Aerosol of Staphylococcus aureus according to ASTM F2100:2019
- Sample size: 32/32
- Pass criteria: ≥ 95%
- Test results: Passed at ≥95%
- Differential pressure (Delta-P):
- Test method: EN 14683: 2019, Annex C Medical face masks - Requirements and test methods according to ASTM F2100:2019
- Sample size: 32/32
- Pass 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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June 8, 2021
Shenzhen Peninsula Medical Co. Ltd % Cassie Lee Manager Share Info (Guangzhou) Medical Consultant Ltd. No. 1919-1920, Building D3. Minjie Plaza, Shuixi Road Huangpu District Guangzhou, Guangdong 510700 China
Re: K202126
Trade/Device Name: Disposable Surgical Mask (Model: Flat-type) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: April 28, 2021 Received: May 11, 2021
Dear Cassie Lee:
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,
Ryan Ortega, PhD Acting 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) K202126
Device Name Disposable Surgical Mask (Model: Flat-type)
Indications for Use (Describe)
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
| 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 for K202126
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92.
1. Submitter's Information
510(k) Owner's Name: Shenzhen Peninsula Medical Co. Ltd. Establishment Registration Number: 3016746323 Address: 3F Block A, Building F2, Changfeng Industrial Park, Liuxian 3rd Road, 68# Xin'an Street, Bao'an District, Shenzhen, 518100, P.R.China. Contact Person: Zhang Sudi Email: 283068426@qq.com
Application Correspondent:
Contact Person: Ms. Cassie Lee Share Info (Guangzhou) Medical Consultant Ltd. Address: No. 1919-1920, Building D3, Minjie Plaza, Shuixi Road, Huangpu District, Guangzhou, China Tel: +86 20 8266 2446 Email: regulatory@glomed-info.com
2. Date of the summary prepared: June 8, 2021
3. Subject Device Information
Type of 510(k): Traditional Classification Name: Mask, Surgical Common name: Surgical Mask Trade Name: Disposable Surgical Mask Model Name: Flat-type Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
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4. Predicate Device Information
Sponsor: Acme Filter Mask Inc. Trade Name: Surgical Face Mask with Ear-Loop Classification Name: Mask, Surgical Common name: Surqical Mask 510(K) Number: K123115 Review Panel: Surgical Apparel Product Code: FXX Regulation Number: 21 CFR 878.4040 Regulatory Class: II
5. Device Description
The Disposable Surgical Mask is Flat Pleated style mask, utilizing ear loops way for wearing, and they all has nose piece design for fitting the Disposable Surgical Mask around the nose.
The Disposable Surgical Mask are manufactured with three layers, the inner and outer layers are made of spun bond polypropylene, only the outer layers' color is blue (colorant: 29H,31H-phthalocyaninato(2-)-N29,N30,N31,N32 copper, CAS number: 147-14-8) and the middle layer is made of melt blown polypropylene filter.
The model of proposed device, ear loops, is held in place over the users' mouth and nose by two elastic ear loops welded to the Disposable Surgical Mask. The elastic ear loops are not made with natural rubber latex.
The nose piece contained in the Disposable Surgical Mask is in the middle layer of Disposable Surgical Mask to allow the user to fit the Medical surgical mask around their noses, which is made of malleable aluminum wire.
The Medical surgical mask is sold non-sterile and is intended to be single use, disposable device. The dimensions of each Disposable Surgical Mask is length 17.5cm±1cm and width 9.5cm±1cm. The dimensions of nosepiece is length 85±1 mm and width 3.0±0.5 mm, and the ear loop is length 180±10 mm and width 3.0±0.5 mm.
The Disposable Surgical bag packaging material is Polypropylene and box packaging are carton.
6. Intended Use / Indications for Use
Disposable Surgical Mask is Device that is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operation room personnel from transfer of microorganisms, body fluids and particulate material.
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| Elements of
| Comparison | Subject Device | Predicate Device | Verdict |
|---|---|---|---|
| Company | Shenzhen Peninsula Medical Co. | ||
| Ltd. | Acme Filter Mask Inc. | -- | |
| 510 (k) | K202126 | K123115 | -- |
| Trade Name | Disposable Surgical Mask | Surgical Face Mask with Ear-Loop | -- |
| Classification | |||
| Name | Mask, Surgical | Mask, Surgical | Same |
| Classification | Class II Device, FXX (21 | ||
| CFR 878.4040) | Class II Device, FXX (21 | ||
| CFR 878.4040) | Same | ||
| Intended use | Disposable Surgical Mask is | ||
| Device that is intended to be worn | |||
| by operating room personnel | |||
| during surgical procedures to | |||
| protect both the surgical patient | |||
| and the operation room personnel | |||
| from transfer of microorganisms, | |||
| body fluids and particulate | |||
| material. | Surgical Face Mask is Device that | ||
| is intended to be worn by operating | |||
| room personnel during surgical | |||
| procedures to protect both the | |||
| surgical patient and the operation | |||
| room personnel from transfer of | |||
| microorganisms, body fluids and | |||
| particulate material. | Same | ||
| Material | |||
| Outer facing | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner facing | |||
| layer | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose piece | Malleable aluminum wire | Malleable aluminum wire | Same |
| Ear loops | Polyester | Polyester | Same |
| Design | Color: Blue | Color: Blue | Same |
| features | Ear loops | Ear loops | Same |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Specification | Length: 17.5cm+1cm | Length: 17.5cm+1cm | Same |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Verdict |
| and | |||
| Dimension | Width: 9.5cm±1cm | Width: 9.5cm±1cm | Same |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance | |||
| Testing | Level 1 | Level 1 | Same |
| Fluid | |||
| Resistance | |||
| Performance | Pass at 80 mmHg | Fluid Resistance | Different |
| Note 1 | |||
| Particulate | |||
| Filtration | |||
| Efficiency | ≥ 95% | Average 94.79% for Solid Aerosol | |
| Filtration Efficiency | |||
| Efficiency More than 99.5% for | |||
| Viral Filtration Efficiency | Different | ||
| Note 1 | |||
| Bacterial | |||
| Filtration | |||
| Efficiency | ≥ 95% | pass at 99.9% | Different |
| Note 1 | |||
| Differential | |||
| Pressure |