(501 days)
Not Found
No
The 510(k) summary describes a standard surgical mask and does not mention any AI or ML components or functionalities.
No.
A therapeutic device is used to treat or cure a disease or condition, whereas this device is intended for protection and infection control.
No
The device description indicates that the "Skypro, SP02 Mask (Level 3)" is intended to protect individuals from the transfer of microorganisms and particulate material, functioning as a barrier rather than for diagnosis.
No
The device description clearly states it is a physical surgical mask made of fabrics, earloops, and a nose clip, with performance studies focused on physical properties like filtration and fluid resistance. There is no mention of software components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that 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 a sample taken from the body.
- Device Description: The description details the physical components of a mask (fabrics, earloops, nose clip). There are no components or mechanisms described that would be used to analyze a biological sample.
- Performance Studies: The performance studies focus on the physical properties of the mask, such as fluid resistance, filtration efficiency, breathability (differential pressure), and flammability. These are relevant to the mask's function as a barrier, not to 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 analysis.
In summary, the "Skypro, SP02 Mask (Level 3)" is a personal protective equipment (PPE) device designed to prevent the transmission of infectious agents through physical filtration and barrier properties. It does not perform any in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
"Skypro, SP02 Mask (Level 3)" 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 infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
Product codes
FXX
Device Description
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
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)
Summary of Non-Clinical Testing:
Clinical Performance Test: No clinical testing was performed.
Biocompatibility Test:
- Cytotoxicity Test: MEM Elution GLP Report; Result: Non-cytotoxic
- Sensitization Test: Kligman Maximization Test - ISO (GLP); Result: Non-sensitizing
- Primary Skin Irritation Test: Intracutaneous Injection Test - ISO (GLP); Result: Non-irritating
Fluid Resistance Test: Pass @ 160 mmHg
Particle Filtration Efficiency Test: 98.59%
Bacterial Filtration Efficiency (BFE) Test: 99.24%
Differential Pressure (Delta P) Test: 4.04 mmH2O/cm²
Flammability Test: Class 1
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Fluid Resistance Performance: Pass @ 160 mmHg
Particulate Filtration Efficiency Performance: 98.59%
Bacterial Filtration Efficiency Performance: 99.24%
Differential Pressure (Delta P): 4.04 mmH2O/cm²
Flammability Class: Class 1
Cytotoxicity: Non-cytotoxic
Sensitization: Non-sensitizing
Primary Skin Irritation: Non-irritating
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 24, 2021
Skypro Medical Supplies Company Cyrus Wong General Manager C301, Tsing Yi Industrial Centre Phase 2, 1-33 Cheung Tat Road, Tsing Yi, N.T. Hong Kong. China
Re: K202255
Trade/Device Name: Skypro, SP02 Mask (Level 3) Regulation Number: 21 CFR 878.4040 Regulation Name: Surgical apparel Regulatory Class: Class II Product Code: FXX Dated: December 9, 2021 Received: December 13, 2021
Dear Cyrus Wong:
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.
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
1
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 W. Murray, III, PhD Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202255
Device Name Skypro, SP02 Mask (Level 3)
Indications for Use (Describe)
"Skypro, SP02 Mask (Level 3)" 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 infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, single-use, and disposable device.
| Description | Item No. | Color | Size |
|---|---|---|---|
| Earloop mask | L3RELX | Blue | 175 mm x 95 mm |
| Earloop mask | L3MELX | Blue | 145 mm x 95 mm |
| Tie-on mask | L3RTOX | Blue | 175 mm x 95 mm |
| 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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary K202255
Skypro Medical Supplies Company
Date of Submission: 9th December, 2021 Date of Preparation: 9th December, 2021
1. Manufacturer
Company: SPRO Medical Products (Xiamen) Co., Ltd Address: No.139 Factory Building, TongAn Garden, TongAn Industrial Area, Xiamen, Fujian Province, 361100, P. R. China
2. Official Correspondent and Applicant
Contact Person: Cyrus Wong (General Manager) Company: Skypro Medical Supplies Company Address: Flat C301, 3/F, Block C, Phase 2, Tsing Yi Industrial Centre, 1-33 Cheung Tat Road, Tsing Yi, New Territories, Hong Kong, P. R. China Phone No.: 852-27110882 Fax No.: 852-27110116 Email: cyrus@skypro-med.com
3. US Agent and Correspondent
Company: SKYPRO MEDICAL SUPPLIES USA LTD COMPANY Address: 5722 Kendall Hill Ln, Sugar Land, TX 77479 Contact Person: Eve Luo Email: Eve@1masks.com Phone No.: 832-312-2668 EIN/TAX ID: 851587593
4. Details of Device
Device Trade Name: Skypro, SP02 Mask (Level 3) Classification Name: Mask, Surgical (21 CFR 878.4040) Class: Class II Classification Panel: General and Plastic Surgery Product Code: FXX Device Common Name/ Classification Name: Surgical Mask Predicate Device: Skypro, SP01 Mask (K152197)
4
Labels/ Labeling:
"Skypro, SP02 Mask (Level 3)" is marketed as a single-use and disposable surgical or procedure mask. It is a prescription device.
Intended Use:
"Skypro, SP02 Mask (Level 3)" 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 infection control practices to reduce the potential exposure of the wearer to blood and body fluids. It is a non-sterile, singleuse, and disposable device.
Device Description:
"Skypro, SP02 Mask (Level 3)" is a flat-pleated surgical or procedure mask. It is composed of 4-layer spunbond/meltblown polypropylene fabrics, elastic earloops or ties, and a moldable nose clip.
| No. | Item No. | Description |
|---|---|---|
| 1 | L3RELX | The face mask (size: 175 mm x 95 mm) is composed of four-layer non-woven |
| polypropylene fabrics, a moldable nose clip, and earloops. The earloops are attached | ||
| to the corners of mask blank. Seam sealing is applied to the edge of mask blank. | ||
| 2 | L3RTOX | The face mask (size: 175 mm x 95 mm) is composed of four-layer non-woven |
| polypropylene fabrics, a moldable nose clip, and ties. Seam sealing is applied to | ||
| the edge of mask blank. | ||
| 3 | L3MELX | The face mask (size: 145 mm x 95 mm) is composed of four-layer non-woven |
| polypropylene fabrics, a moldable nose clip, and earloops. The earloops are attached | ||
| to the corners of mask blank. Seam sealing is applied to the edge of mask | ||
| blank. |
Note: The details of each item have been indicated in the relevant "Product Drawing" files.
Technological Characteristic Comparison with Predicated Device:
| Description | Predicate K152197
"Skypro, SP01
Mask" | Subject Device K202255
"Skypro, SP02 Mask (Level 3)" | Comparison |
|----------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------|------------|
| Materials | | | |
| Outer Layer | Spunbond polypropylene | Spunbond polypropylene | Similar |
| Middle Layer | Meltblown polypropylene | 1st Spunbond polypropylene
2nd Meltblown polypropylene | Similar |
| Inner layer | Spunbond polypropylene | Spunbond polypropylene | Similar |
| Nose Piece | Metal wire(s) coated
with polyethylene | Metal wire(s) coated with
polyethylene | Similar |
| Ear Attachment | Elastic latex-free
earloops or ties | Elastic latex-free earloops or
ties | Similar |
| Specification
and Physical
Sizes | Earloop mask:
175 mm x 95
mm;
145 mm x 95
mm; Tie-on
mask:
175 mm x 95 mm | Earloop mask: 175
mm x 95 mm;
145 mm x 95 mm;
Tie-on mask:
175 mm x 95 mm | Similar |
| Mask Style | Flat-pleated | Flat-pleated | Similar |
5
| Design Features | 3 layers of non-
woven fabrics with a
dense fiber | 4 layers of non-woven fabrics with
a dense fiber web as one | Similar |
| ----------------- | --------------------------------------------------------- | ---------------------------------------------------------------- | --------- |
|---|
| | web as the middle layer | of the middle layers | Similar | Test Methodology | Purpose | Acceptance
Criteria | Result |
|-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------|-----------------|
| Color | White | Blue | Different | 1. Biocompatibility Test | | | |
| Indications for Use | "Skypro, SP01 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 infection control
practices to reduce the potential
exposure of the wearer to blood
and body fluids. It is a non-
sterile, single-
use, and disposable device. | "Skypro, SP02 Mask (Level 3)" 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 infection control practices to reduce
the potential exposure of the wearer to
blood and body fluids. It is a non-
sterile, single-
use, and disposable device. | Similar | - Cytotoxicity Test: MEM Elution
GLP Report; | To determine if the mask may cause
cytotoxic effects | Non-cytotoxic | Non-cytotoxic |
| Performance Characteristics | | | | - Sensitization Test: Kligman
Maximization Test - ISO (GLP) | To determine if the mask may cause
skin sensitization | Non-sensitizing | Non-sensitizing |
| Fluid Resistance
Performance
(mmHg) | Pass @ 120 mmHg | Pass @ 160 mmHg | Different | - Primary Skin Irritation Test:
Intracutaneous Injection Test -
ISO (GLP) | To determine if the mask may cause
skin irritation | Non-irritating | Non-irritating |
| Particulate Filtration
Efficiency
Performance | 99.28% | 98.59% | Similar | 2. Fluid Resistance Test | To determine the capability of mask
to resist the penetration of fluids | Pass @
160 mmHg | Pass |
| Bacterial Filtration
Efficiency Performance | 99.66% | 99.24% | Similar | 3. Particle Filtration Efficiency Test | To measure the filtration efficiency of
mask for particulates | ≥ 98% | 98.59% |
| Differential
Pressure (Delta P) | 3.72 mmH2O/cm² | 4.04 mmH2O/cm² | Similar | 4. Bacterial Filtration Efficiency
(BFE) Test | To measure the filtration efficiency of
mask for bacteria | ≥ 98% | 99.24% |
| Flammability Class | Class 1 | Class 1 | Same | 5. Differential Pressure (Delta P)
Test | To measure how easily air is passed
from one side of the mask to the
other, which can function as
an
indicator of air permeability
or
breathability |