(259 days)
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.
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.
The provided text describes the acceptance criteria and the study that proves the device meets the acceptance criteria for the "Grande Medical Masks, Model SF-600".
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (F2100-19 Level 2) | Reported Device Performance | Result |
|---|---|---|---|
| Bacteria Filtration Efficiency (ASTM F2101) | ≥ 98 % | Pass at 99 % | Pass |
| Particle Filtration Efficiency (ASTM F2299) | ≥ 98 % | Pass at 99% | Pass |
| Differential Pressure (EN 14683:2019) | < 6.0 mmH2O/cm² | Less than 4.5 mmH2O/cm² | Pass |
| Resistance to penetration by synthetic blood (ASTM F1862) | 120 mmHg (≥ 29/32 show passing results per lot) | 120 mmHg | Pass |
| Flammability (16 CFR Part 1610) | Class I (Burn time ≥3.5 s, IBE, or DNI) | Class I | Pass |
| In vitro Cytotoxicity (ISO 10993-5) | Non-cytotoxic | Non-cytotoxic | Pass |
| Skin sensitization Test (ISO 10993-10) | Not a sensitizer | Not a sensitizer | Pass |
| Skin Irritation Test (ISO 10993-10) | Not an irritant | Not an irritant | Pass |
2. Sample size used for the test set and the data provenance:
The document does not explicitly state the sample sizes used for each specific non-clinical test. However, it indicates standard test methodologies like ASTM F2101, F2299, F1862, EN 14683:2019, 16 CFR Part 1610, ISO 10993-5, and ISO 10993-10, which inherently involve specific sample sizes as part of their standardized procedures. The data provenance is derived from these non-clinical tests, which are conducted in a controlled environment as per international and national standards. The country of origin of the data is not specified beyond the reference to the manufacturer, Golden Grande Corp. in Taiwan. The data is retrospective in the sense that it's generated from lab tests, not from observations of real-world use over time.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable. For medical masks, ground truth is established by objective pass/fail criteria of standardized performance tests, not by expert consensus on subjective interpretations. The "experts" involved are the certified laboratories and technicians performing the tests according to the specified methodologies.
4. Adjudication method for the test set:
Not applicable. The tests conducted for medical masks (e.g., bacterial filtration, particle filtration, differential pressure) yield objective, quantifiable results that are directly compared against predefined numerical acceptance criteria. There is no subjective interpretation or multi-reader adjudication process involved.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a medical mask, a physical barrier device, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. As stated above, this is a physical medical device, not an algorithm or software. No standalone algorithm-only performance testing was performed because there is no algorithm.
7. The type of ground truth used:
The ground truth used is based on objective, quantifiable results derived from standardized in vitro and in vivo (for biocompatibility) performance tests. These tests have established pass/fail criteria defined by international and national standards (e.g., ASTM F2100-19 Level 2 criteria, ISO 10993 standards). This is not expert consensus, pathology, or outcomes data in the usual sense, but rather a direct measurement of the device's physical and biological properties against established safety and performance benchmarks.
8. The sample size for the training set:
Not applicable. This device is a medical mask, not a machine learning model. Therefore, there is no "training set" in the context of AI or software development.
9. How the ground truth for the training set was established:
Not applicable. As there is no training set for a medical mask, there is no ground truth established for it.
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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).
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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
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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) 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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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 TsengPhone: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 Descriptionand TechnologyCharacteristics | Grande Medical Masks are 4-layer surgical masks that covers theuser's nose and mouth and provides a physical barrier to fluidsand particulate materials. This device is non-sterile and for singleuse only.The mask is constructed of nonwoven fabric, including the bottomlayer, surface layer 1, surface layer 2 and middle layer, and isprovided with ear loops and nose clip. |
| Models | SF-600 |
| Indications for Use | Grande Medical Masks is intended to be worn to protect both thepatient and healthcare personnel from the transfer ofmicroorganisms, body fluids and particulate material. These facemasks are intended for use in infection control practices to reducethe potential exposure to blood and body fluids. The GrandeMedical 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
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| Classification | II | II | Same |
|---|---|---|---|
| OTC use | YES | YES | Same |
| Intended Use | Grande Medical Masks is intended tobe worn to protect both the patient andhealthcare personnel from the transferof microorganisms, body fluids andparticulate material. These face masksare intended for use in infection controlpractices to reduce the potentialexposure to blood and body fluids. TheGrande Medical Masks are single use,disposabledevice, providednon-sterile. | The surgical face masks are intendedto be worn to protect both the patientand healthcare personnel fromtransfer of microorganisms, bodyfluids, and particulate material. Theseface masks are intended for use ininfection control practices to reducethe potential exposure to blood andbody fluids. This is a single-use,disposable device, provided non-sterile. | Same |
| Dimensions | 175±3 mm x 95±3 mm | 90mm±3175±5mm,90mm±3180±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: PolypropylenespunbondSurface Layer 2: PolypropylenespunbondMiddle Layer: PolypropyleneMeltblownBottom Layer: PolypropyleneSpunbondNose Clip: malleable aluminum wirecovered with polyethyleneEar Loops: Polyamide | Outer Layer: Polypropylene.Filter Layer 1: PolypropylenespunbondFilter Layer 2: PolypropylenemeltblownInner Layer: polypropylene.Earloops: Polyester, polyurethaneSide tapes: Polyester spunbond (earloops mask only)Tie tapes: Polypropylene spunbondor polyester spunbondNose clamp: Polyethylene coatedsteel wire | Similar |
| ASTM Level | 2 | 1,2,3 | Similar |
| Fluid ResistanceASTM F1862 | 120 mmHg | 80 mmHg ,120 mmHg or 160 mmHg | Similar |
| Bacterial FiltrationEfficiencyASTM F2101 | Pass at 99 % | Pass at 98% (Level 1)Pass at 98% (Level 2)Pass at 99% (Level 3) | Similar |
| DifferentialPressureMil-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 FiltrationEfficiencyASTM F2299 | Pass at 99% | Pass at 99.6% (Level 1)Pass at 99.6% (Level 2)Pass at 99.7% (Level 3) | Similar |
| Flammability16 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, ISO10993-10) | Same |
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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 | F2100-19Level 2 Criteria | Result |
| Bacteria Filtration Efficiency | Determine the bacterial filtration efficiency asdirected in Test Method ASTM F2101. | ≥ 98 % | Pass |
| Particle Filtration Efficiency | Determine particulate filtration efficiency asdirected in Test Method F2299. | ≥ 98 % | Pass |
| Differential Pressure (Delta-P) | Determine breathing resistance or differentialpressure as directed in EN 14683:2019, AnnexC. | <6.0 mmH2O/cm² | Pass |
| Resistance to penetrationby synthetic blood,minimum pressure in mmHg for pass result | Determine synthetic blood penetrationresistance as specified in Test Method F1862 | 120 mmHg(≥ 29/32 showpassing results perlot) | Pass |
| Flammability | Determine flammability as specified in 16 CFRPart 1610 | Class I(Burn time ≥3.5 s,IBE, or DNI) | Pass |
Non-Clinical Testing Summary
Biocompatibility Testing Summary:
| Test Methodology | Purpose of the test | Criteria | Results |
|---|---|---|---|
| In vitro Cytotoxicitytest | Determine the effects on cells following ISO 10993-5 | Under the conditions ofthe test, non-cytotoxic | Pass |
| Skin sensitization Test | Estimate the potential for contactsensitization following ISO 10993-10 | Under the conditions ofthe test, not asensitizer | Pass |
| Skin Irritation Test | Estimate the irritation potential ofmedical device following ISO 10993-10 | Under the conditions ofthe test, not an irritant | Pass |
A shelf-life evaluation was conducted, and the test results demonstrate that the device maintains its performance in its claimed 3-year shelf life.
Discussion on No clinical testing was performed in support of this submission.
Clinical Test Performed
Conclusion The conclusions drawn from the non-clinical tests demonstrate
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that the subject device, Grande Medical Masks is as safe, as effective, and performs as well as or better than the legally marketed predicate device K160269.
§ 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.