(88 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask, with no mention of AI or ML.
No.
The device description and intended use clearly state that the mask is for protection and infection control, not for treating or preventing a specific disease or condition in a therapeutic manner.
No
The device is a surgical face mask intended to protect against the transfer of microorganisms, body fluids, and particulate material, not to diagnose a medical condition.
No
The device description clearly outlines a physical, multi-layer surgical face mask made of materials like polypropylene and polyethylene wire, with ear loops and a nose piece. This is a hardware device, not software.
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, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Device Function: The Plain Surgical Face Mask is a physical barrier worn on the face. Its function is to prevent the transfer of microorganisms, body fluids, and particulate material between individuals. It does not analyze or test any biological samples.
- Intended Use: The intended use clearly states it's for protection and infection control by reducing exposure to blood and body fluids. This is a barrier function, not a diagnostic function.
The description and testing performed (fluid resistance, filtration efficiency, flammability, biocompatibility) are all related to the physical performance and safety of the mask as a barrier, not its ability to diagnose or analyze biological samples.
N/A
Intended Use / Indications for Use
The Plain 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. The 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, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask and with adjustable clips. The elastic ear loops are not made with natural rubber latex. 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 surgical face 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 Testing Summary:
- Fluid Resistance (ASTM F1862): 29 out of 32 pass at 120 mmHg. Acceptance Criteria: 29 out of 32 pass at 120 mmHg.
- Flammability class 16 CFR Part 1610: Class I Non-Flammable. Acceptance Criteria: Meets Class I, No flame spread on 5 of 5.
- Particulate Filtration Efficiency ASTM F2299: Average 99.79% Efficiency. Acceptance Criteria: >= 98% Efficiency.
- Bacterial Filtration Efficiency ASTM F2101: >99% Efficiency. Acceptance Criteria: >= 98% Efficiency.
- Differential Pressure (Delta P) ASTM F2100-9 and EN 14683:2019: Average 3.2 mmH2O/cm^2 (Range 3.1-3.4). 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.
September 4, 2020
AOK Tooling Limited % Paul Dryden Consultant ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704
Re: K201517
Trade/Device Name: Plain Surgical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical Apparel Regulatory Class: Class II Product Code: FXX Dated: June 4, 2020 Received: June 8, 2020
Dear Mr. Paul Dryden:
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 (OS) 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.
CAPT Elizabeth Claverie, MS 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) K201517
Device Name Plain Surgical Face Mask
Indications for Use (Describe)
The Plain 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. The 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, 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
Date Prepared:
02-Sep-2020
| Sponsor: | AOK Tooling Limited
#8, Longtian 3Rd, Longtian Street, Pingshan Dist.
Shenzhen, China 518122
Tel: +852-0-23101703 |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------|
| Sponsor Contact: | Francis Nithyananthan
Project Director |
| Proprietary or Trade Name: | Plain Surgical Face Mask |
| Common Name: | Mask, Surgical |
| Classification Name: | Surgical apparel |
| Classification: | Class II |
| Product Code: | FXX |
| Regulation Number: | 21 CFR 878.4040 |
| Predicate Devices: | Wuhan Dymex Healthcare Co., Ltd. - Surgical Face Mask - K18251 |
Device Description:
The Plain Surgical Face Mask is a single use, three-layer, flat-folded masks with ear loops and adjustable clips and nose piece. The Plain Surgical Face Mask is manufactured with three layers, the inner and outer layers are made of spunbonded polypropylene, and the middle layer is made of melt blown polypropylene filter. The ear loops are held in place over the users' mouth and nose by two elastic ear loops welded to the facemask and with adjustable clips. The elastic ear loops are not made with natural rubber latex. 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 surgical face masks are sold non-sterile and are intended to be single use, disposable devices.
Indications for Use:
The Plain 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. The 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, provided non-sterile.
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| Table 1: Comparison to Predicate | |||
|---|---|---|---|
| Description | Predicate Device | Proposed Device | Comparison |
| Manufacturer | Wuhan Dymex Healthcare Co Ltd | AOK Tooling Ltd. | |
| 510(k) Number | K182515 | K201517 | |
| Device Name | Surgical Face Mask | Plain Surgical Face Mask | |
| Classification | Class II Device | ||
| FXX | |||
| 21 CFR878.4040 | Class II Device | ||
| FXX | |||
| 21 CFR878.4040 | Same | ||
| Intended use | The 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. The 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, | |||
| provided non-sterile. | The Plain 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. The 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, provided non- | |||
| sterile. | Same | ||
| Model | Ear Loops, Flat Pleated | ||
| 3 layers | Ear Loops with adjustable clips, Flat | ||
| Pleated, 3 layers | Similar | ||
| Materials | |||
| Outer Cover Fabrics | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Middle Layer | Melt blown polypropylene filter | Melt blown polypropylene filter | Same |
| Inner Facing | Spun-bond polypropylene | Spun-bond polypropylene | Same |
| Nose Piece | Malleable polyethylene wire | Malleable polyethylene wire | Same |
| Ear Loops/Adjustable Clips | Spandex ear loops | Spandex ear loops and polypropylene clips | Similar |
| Color | Yellow | White | Different |
| Dimension (Length) | 17.5cm ± 0.2cm | 17.5cm ±0.2cm | Same |
| Dimension (Width) | 9.5cm ± 0.2cm | 9.5cm ± 0.2cm | Same |
| OTC Use | Yes | Yes | Same |
| Sterile | Non-sterile | Non-sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| ASTM 2100 Level | Level 2 | Level 2 | Same |
Summary of Technological Characteristics:
Table 2: Performance Testing
March 5, 2004.
Non-Clinical Testing Summary:
| Description | Subject Device | Acceptance Criteria |
|---|---|---|
| Fluid Resistance (ASTM F1862) | 29 out of 32 pass at 120 mmHg | 29 out of 32 pass at 120 mmHg |
| Flammability class | ||
| 16 CFR Part 1610 | Class I Non-Flammable | Meets Class I, No flame spread on 5 of 5 |
| Particulate Filtration Efficiency | ||
| ASTM F2299 | Average 99.79% Efficiency | ≥ 98% Efficiency |
| Bacterial Filtration Efficiency | ||
| ASTM F2101 | >99% Efficiency | ≥ 98% Efficiency |
| Differential Pressure (Delta P) | ||
| ASTM F2100-9 and | ||
| EN 14683:2019 | Average 3.2 $mmH_2O/cm^2$ (Range 3.1-3.4) |