(22 days)
Not Found
No
The device description and performance studies focus on the physical properties and filtration capabilities of a standard surgical face mask. There is no mention of AI, ML, image processing, or any computational analysis of data.
No.
The device description and intended use clearly state that it is a surgical face mask used for protection and infection control, not for treating any medical condition.
No
This device is a surgical face mask intended to protect against transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly outlines a physical, multi-layered mask constructed of nonwoven polypropylene materials with ear loops and a nose piece. The performance studies focus on physical properties and biocompatibility, not software functionality.
No, 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 on samples taken from the body.
- Device Description: The description details the physical construction and materials of the mask. There is no mention of reagents, assays, or any components used to analyze biological samples.
- Performance Studies: The performance studies focus on the physical properties and barrier effectiveness of the mask (fluid resistance, filtration efficiency, breathability, flammability, biocompatibility). These are not studies related to the accuracy or performance of a diagnostic test.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This mask does not perform any such function.
Therefore, based on the provided information, the Perfetta Moderate Medical Face Mask is a medical device, but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Perfetta Moderate Medical 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 surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
Product codes (comma separated list FDA assigned to the subject device)
FXX
Device Description
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
This subject device is provided with size 17.5 cm ± 0.5 cm.
The subject device is single-use, disposable device, provided non-sterile.
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)
Non-clinical tests were performed.
Fluid Resistance Performance ASTM F1862: ≥29 out of 32 passed in 120 mmHg (Level 2). Conclusion: Pass.
Particulate Filtration Efficiency ASTM F2299: ≥98% at 0.1µm. Conclusion: Pass.
Bacterial Filtration Efficiency ASTM F2101-19: ≥98%. Conclusion: Pass.
Differential Pressure (Delta P):
§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 2, 2022
Phu Bao Group Company Limited % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K222426
Trade/Device Name: Perfetta Moderate Medical Face Mask Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: August 9, 2022 Received: August 11, 2022
Dear Prithul Bom:
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.
Brent Showalter, Ph.D. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic 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) K222426
Device Name Perfetta Moderate Medical Face Mask
Indications for Use (Describe)
Perfetta Moderate Medical Face Mask is intended to be worn to protect and healthcare personnel from transfer of microorganisms, body fluids and particulate material. This surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
510(k) SUMMARY
This 510(k) Summary as per 21 CFR 807.92
Date of submission: July 25, 2022
(1) Applicant information
| 510(k) Owner/ Applicant: | PHU BAO GROUP COMPANY LIMITED |
|---|---|
| Address: | Head office: |
| PHU BAO GROUP COMPANY LIMITED | |
| 5 floor, CJ Building, 02Bis-4-6 Le Thanh Ton Street, | |
| Ben Nghe Ward, District 1, Hochiminh city, Vietnam, 70000 | |
| Factory: | |
| PHU BAO MEDICAL CO., LTD | |
| Lot C21, D2 Road, Cau Tram Industrial Park, | |
| Long Trach Ward, Can Duoc Dist., | |
| Long An province, Vietnam. | |
| Contact: | Le Pham Minh Ngoc (Ms.) |
| Email: | info@phubaogroup.com.vn; |
| consultant.fda@phubaomedical.com | |
| Phone: | +84-28-3914 2980 |
| Owner/Operator Number: | 10074628 |
| FEI Number: | 3016615220 |
| US Agent: | THANH PHONG KIEM NGUYEN GOLUS LLC at address: |
| 421 Sletten Drive, Lawrenceville, GA US 30046 | |
| Contact of US agent: | THANH PHONG KIEM NGUYEN, Phone: 470 4189790, |
| Email: golus@gol.vn | |
| Correspondent: | Regulatory Technology Services at address: 1000 |
| Westgate Drive, Suite #510, Saint Paul, Minnesota, 55114 | |
| Contact of Correspondent: Ms. Prithul Bom - Accredited Person, Reviewer | |
| Phone 612-963-0379 |
4
Email: prithul.bom@rts3pro.com
(2) Subject device
| Trade name: | Perfetta Moderate Medical Face Mask |
|---|---|
| Model number: | PT3B50 |
| Common Name: | Surgical Face Mask |
| Classification Name: | Masks, Surgical |
| Review Panel: | General Hospital |
| Regulation Medical Specialty: | General & Plastic Surgery |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(3) Predicate device
| Submitter: | MEGASOFT(CHINA) CO., LTD |
|---|---|
| Device name: | Surgical Face Mask |
| 510(k) number: | K213617 |
| Product Code: | FXX |
| Device Classification: | Class II per 21 CFR §878.4040 |
(4) Description of device
The subject device is three-layers, flat-pleated mask constructed of nonwoven polypropylene materials, the inner and outer layers are made of spunbond polypropylene, and the middle layer is made of melt blown polypropylene.
The subject device is provided with ear loops. Ear loops is made of 80% polyester 20% spandex, not made with natural rubber latex.
A zinc wire nose piece with polypropylene coating is placed within the binding for comfort and individualized fit, allow the user to fit the facemask around their nose.
The subject device is provided in blue color. The blue colorant is made of polypropylene master batch.
This subject device is provided with size 17.5 cm ± 0.5 cm.
The subject device is single-use, disposable device, provided non-sterile.
5
(5) Indications for use
Perfetta Moderate Medical 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 surgical face mask is intended for use in infection control practices to reduce the potential exposure to blood and body fluids. This is single use, disposable device, provided non-sterile.
| Item | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| 510 (k) | |||
| number | - | K213617 | Not |
| applicable | |||
| Applicant | PHU BAO GROUP | ||
| COMPANY LIMITED | MEGASOFT(CHINA) CO., | ||
| LTD | Not | ||
| applicable | |||
| Product | |||
| Name | Perfetta Moderate Medical | ||
| Face Mask | Surgical Face mask | Not | |
| applicable | |||
| Model | |||
| number | PT3B50 | MGSM-01 | Not |
| applicable | |||
| Device class | Class II Device, FXX | ||
| (21 CFR 878.4040) | Class II Device, FXX | ||
| (21 CFR 878.4040) | Same | ||
| Indications | |||
| for Use | Perfetta Moderate Medical | ||
| 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 | |||
| surgical face mask is | |||
| intended for use in infection | |||
| control practices to reduce | |||
| the potential exposure to | |||
| blood and body fluids. This is | |||
| single use, disposable | |||
| device, provided non-sterile. | 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. These face masks | |||
| are intended for use in | |||
| infection control practices to | |||
| reduce the potential | |||
| exposure to blood and body | |||
| fluids. This is single use, | |||
| disposable device(s), | |||
| provided non-sterile. | Same | ||
| Material | |||
| Outer layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Middle layer | Meltblown polypropylene | Meltblown polypropylene | Same |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Same |
| Nose piece | Zinc wire with polypropylene | ||
| coating | Polypropylene, iron and zinc | Different | |
| Design | |||
| Features | Ear loops: 80% polyester | ||
| 20% spandex | Ear loops: elastics film | Similar | |
| Mask Style | Flat Pleated | Flat Pleated | Same |
| Color | Blue | Blue | Same |
| Specification | |||
| and | |||
| Dimension | Length: 17.5cm±0.5cm | ||
| Width: 9.5cm±0.5cm | Length: 17.5cm±0.5cm | ||
| Width: 9.5cm±0.5cm | Same | ||
| Dimension | |||
| ear loops | Length: 17.5cm±0.5cm | ||
| Width: 0.40cm±0.02cm | - | Different | |
| OTC use | Yes | Yes | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use, Disposable | Single Use, Disposable | Same |
| Performance Characteristics | |||
| Fluid | |||
| Resistance | |||
| Performance | |||
| ASTM | |||
| F1862 | Pass at 120 mmHg | ||
| (Level 2 Fluid Resistance) | Pass at 120 mmHg | ||
| (Level 2 Fluid Resistance) | Same | ||
| Particulate | |||
| Filtration | |||
| Efficiency | |||
| ASTM | |||
| F2299 | ≥98% at 0.1µm | ≥98% at 0.1µm | Same |
| Bacterial | |||
| Filtration | |||
| Efficiency | |||
| ASTM | |||
| F2101-19 | ≥98% | ≥98% | Same |
| Differential | |||
| Pressure | |||
| (Delta P) |