(259 days)
Not Found
No
The summary describes a standard surgical mask and does not mention any AI or ML components or functionalities. The performance studies focus on filtration efficiency and material properties, not algorithmic performance.
No
The device is a surgical face mask intended for barrier protection, not for treating any medical condition.
No
This device is a surgical mask intended to protect against the transfer of microorganisms and fluids, not to diagnose a condition.
No
The device description clearly states it is a physical surgical mask made of nonwoven fabric with ear loops and a nose clip, and the performance studies focus on physical properties like filtration efficiency and resistance to penetration.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections. These tests are performed outside of the body.
- Device Function: The Grande Medical Mask is a physical barrier intended to protect against the transfer of microorganisms, body fluids, and particulate material. It is worn on the face and does not involve testing samples from the body.
- Intended Use: The intended use clearly states its purpose is for protection and infection control by reducing exposure to blood and body fluids. This is a physical barrier function, not a diagnostic function.
- Device Description: The description details the physical construction of the mask and its components, not any diagnostic testing capabilities.
- Performance Studies: The performance studies focus on the mask's barrier properties (filtration efficiency, resistance to penetration) and biocompatibility, which are relevant to its function as a physical barrier, not a diagnostic test.
Therefore, based on the provided information, the Grande Medical Mask is a medical device, but it falls under the category of a surgical mask or face mask, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the 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. The Grande Medical Masks are single use, disposable device, provided non-sterile.
Product codes
FXX
Device Description
Grande Medical Masks are 4-layer surgical masks that covers the user's nose and mouth and provides a physical barrier to fluids and particulate materials. This device is non-sterile and for single use only. The mask is constructed of nonwoven fabric, including the bottom layer, surface layer 1, surface layer 2 and middle layer, and is provided with ear loops and 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
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)
The proposed devices were tested and conformed to the following standards and the requirements stated in the Guidance for Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission.
Non-Clinical Testing Summary:
- Bacterial Filtration Efficiency: Determine the bacterial filtration efficiency as directed in Test Method ASTM F2101. Result: Pass (≥ 98 %)
- Particle Filtration Efficiency: Determine particulate filtration efficiency as directed in Test Method F2299. Result: Pass (≥ 98 %)
- Differential Pressure (Delta-P): Determine breathing resistance or differential pressure as directed in EN 14683:2019, Annex C. Result: Pass (
§ 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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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.
June 6, 2024
Golden Grande Corp. % Tyra Chiu Regulatory Consultant VOLER Biotech Consulting Co., Ltd. 1F., No. 3-1, Ln. 58, Hejiang St., Zhongshan Dist. Taipei City, 104 Taiwan
Re: K232968
Trade/Device Name: Grande Medical Masks, Model SF-600 Regulatory Class: Not Classified Product Code: FXX Dated: July 8, 2023 Received: September 21, 2023
Dear Tyra Chiu:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
AllanıG
For Bifeng Qian, M.D., Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K232968
Device Name Grande Medical Masks, Model SF-600
Indications for Use (Describe)
Grande Medical Masks is intended to be worn to protect both the patient and healthcare personnel from the 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. The Grande Medical Masks are 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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4
510(k) Summary (K232968)
(As required by 21 CFR 807.92)
| Date | June 4, 2024 |
|---|---|
| Manufacturer/ | |
| 510(k) Owner | Golden Grande Corp. |
| NO. 622-6, GUANGHUA LI, XUEJIA DIST., TAINAN CITY, | |
| 72651, TAIWAN | |
| Contact Person | Hsin Hui Tseng |
| Phone: | |
| E-mail: cindytseng@grande.com.tw | |
| Device Trade Name | Grande Medical Masks |
| Common Name | Surgical Masks |
| Classification Name | Masks, Surgical |
| Device Class | II |
| Medical Specialty | General & Plastic Surgery |
| Regulation Number | 878.4040 |
| Product Code | FXX |
| Device Description | |
| and Technology | |
| Characteristics | Grande Medical Masks are 4-layer surgical masks that covers the |
| user's nose and mouth and provides a physical barrier to fluids | |
| and particulate materials. This device is non-sterile and for single | |
| use only. | |
| The mask is constructed of nonwoven fabric, including the bottom | |
| layer, surface layer 1, surface layer 2 and middle layer, and is | |
| provided with ear loops and nose clip. | |
| Models | SF-600 |
| Indications for Use | Grande Medical Masks is intended to be worn to protect both the |
| patient and healthcare personnel from the 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. The Grande | |
| Medical Masks are single use, disposable device, provided non- | |
| sterile. |
Predicate Device(s) K160269 Surgical Face Masks, SAN-M PACKAGE CO., LTD.
| Proposed Device | Predicate Device | Comparison | |
|---|---|---|---|
| Device Name | Grande Medical Masks | Surgical Face Masks | Different |
| 510(k) # | K232968 | K160269 | Different |
| Applicant | Golden Grande Corp. | SAN-M PACKAGE CO., LTD. | Different |
| Product code | FXX (21 CFR 878.4040) | FXX (21 CFR 878.4040) | Same |
comparison of technological characteristics with the predicate device
5
| Classification | II | II | Same |
|---|---|---|---|
| OTC use | YES | YES | Same |
| Intended Use | Grande Medical Masks is intended to | ||
| be worn to protect both the patient and | |||
| healthcare personnel from the 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. The | |||
| Grande Medical Masks are single use, | |||
| disposable | |||
| device, provided | |||
| non- | |||
| sterile. | The surgical 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, provided non- | |||
| sterile. | Same | ||
| Dimensions | 175±3 mm x 95±3 mm | 90mm±3*175±5mm, | |
| 90mm±3*180±5mm | Similar | ||
| Layers | 4 | 4 | Same |
| Mask Style | Flat-pleated | Flat-pleated | Same |
| Design Feature | Ear loops | Ear loops | Same |
| Sterility | Non-Sterile | Non-Sterile | Same |
| Use | Single Use | Single Use | Same |
| Material: | Surface Layer 1: Polypropylene | ||
| spunbond | |||
| Surface Layer 2: Polypropylene | |||
| spunbond | |||
| Middle Layer: Polypropylene | |||
| Meltblown | |||
| Bottom Layer: Polypropylene | |||
| Spunbond | |||
| Nose Clip: malleable aluminum wire | |||
| covered with polyethylene | |||
| Ear Loops: Polyamide | Outer Layer: Polypropylene. | ||
| Filter Layer 1: Polypropylene | |||
| spunbond | |||
| Filter Layer 2: Polypropylene | |||
| meltblown | |||
| Inner Layer: polypropylene. | |||
| Earloops: Polyester, polyurethane | |||
| Side tapes: Polyester spunbond (ear | |||
| loops mask only) | |||
| Tie tapes: Polypropylene spunbond | |||
| or polyester spunbond | |||
| Nose clamp: Polyethylene coated | |||
| steel wire | Similar | ||
| ASTM Level | 2 | 1,2,3 | Similar |
| Fluid Resistance | |||
| ASTM F1862 | 120 mmHg | 80 mmHg ,120 mmHg or 160 mmHg | Similar |
| Bacterial Filtration | |||
| Efficiency | |||
| ASTM F2101 | Pass at 99 % | Pass at 98% (Level 1) | |
| Pass at 98% (Level 2) | |||
| Pass at 99% (Level 3) | Similar | ||
| Differential | |||
| Pressure | |||
| Mil-M-36954C | Less than 4.5 mmH2O/cm² | Less than 2.0 mmH2O/cm2 (Level 1) | |
| Less than 1.6 mmH2O/cm2 (Level 2) | |||
| Less than 2.5 mmH2O/cm2 (Level 3) | Similar | ||
| Particle Filtration | |||
| Efficiency | |||
| ASTM F2299 | Pass at 99% | Pass at 99.6% (Level 1) | |
| Pass at 99.6% (Level 2) | |||
| Pass at 99.7% (Level 3) | Similar | ||
| Flammability | |||
| 16 CFR 1610 | Class I | Class I | Same |
| Biocompatibility | non- cytotoxic, non-irritating, | ||
| non-sensitizing (ISO 10993-5, | |||
| ISO 10993-10) | non- cytotoxic, non-irritating, non- | ||
| sensitizing (ISO 10993-5, ISO | |||
| 10993-10) | Same |
6
Discussion on The proposed devices were tested and conformed to the following Performance Data standards and the requirements stated in the Guidance for Non-Clinical Tests Industry and FDA Staff: Surgical Masks - Premarket Notification [510(k)] Submission.
| Non-Clinical Testing Summary | |||
|---|---|---|---|
| Test Methodology | Purpose of the test | F2100-19 | |
| Level 2 Criteria | Result | ||
| Bacteria Filtration Efficiency | Determine the bacterial filtration efficiency as | ||
| directed in Test Method ASTM F2101. | ≥ 98 % | Pass | |
| Particle Filtration Efficiency | Determine particulate filtration efficiency as | ||
| directed in Test Method F2299. | ≥ 98 % | Pass | |
| Differential Pressure (Delta- | |||
| P) | Determine breathing resistance or differential | ||
| pressure as directed in EN 14683:2019, Annex | |||
| C. |