← Product Code [FXX](/productcode/FXX) · K232968
# Grande Medical Masks, Model SF-600 (K232968)
_Golden Grande Corp. · FXX · Jun 6, 2024 · General, Plastic Surgery · SESE_
**Canonical URL:** https://fda-staging.innolitics.com/device/K232968
## Device Facts
- **Applicant:** Golden Grande Corp.
- **Product Code:** [FXX](/productcode/FXX.md)
- **Decision Date:** Jun 6, 2024
- **Decision:** SESE
- **Submission Type:** Traditional
- **Regulation:** 21 CFR 878.4040
- **Device Class:** Class 2
- **Review Panel:** General, Plastic Surgery
## 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.
## Device Story
Grande Medical Masks are 4-layer, flat-pleated surgical masks designed to cover the nose and mouth. Constructed from nonwoven polypropylene layers (spunbond and meltblown) with a malleable aluminum nose clip and polyamide ear loops. Used in clinical settings or general infection control to provide a physical barrier against microorganisms, body fluids, and particulate matter. The device is non-sterile and intended for single use. Healthcare personnel or patients wear the mask to reduce exposure to blood and body fluids. Performance is verified through bench testing against ASTM F2100-19 Level 2 standards, including bacterial and particle filtration efficiency, differential pressure, and synthetic blood penetration resistance. The mask provides a protective barrier, reducing the risk of cross-contamination between the wearer and the environment.
## Clinical Evidence
No clinical data. Bench testing only. Performance verified against ASTM F2100-19 Level 2 criteria: Bacterial Filtration Efficiency (99%), Particle Filtration Efficiency (99%), Differential Pressure (<4.5 mmH2O/cm²), and Synthetic Blood Penetration Resistance (120 mmHg). Biocompatibility confirmed via ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization/irritation).
## Technological Characteristics
4-layer flat-pleated mask. Materials: Polypropylene spunbond (surface/bottom layers), Polypropylene meltblown (middle layer), malleable aluminum nose clip (polyethylene-covered), Polyamide ear loops. Performance: ASTM F2100-19 Level 2. Biocompatibility: ISO 10993-5, ISO 10993-10. Non-sterile, single-use. No electronic components or software.
## Regulatory 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.
## Special Controls
*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.
## Predicate Devices
- Surgical Face Masks ([K160269](/device/K160269.md))
## Submission Summary (Full Text)
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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 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
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| 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 |
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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 | F2100-19
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. | <6.0 mmH2O/cm² | Pass |
| Resistance to penetration
by synthetic blood,
minimum pressure in mm
Hg for pass result | Determine synthetic blood penetration
resistance as specified in Test Method F1862 | 120 mmHg
(≥ 29/32 show
passing results per
lot) | Pass |
| Flammability | Determine flammability as specified in 16 CFR
Part 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 Cytotoxicity
test | Determine the effects on cells following ISO 10993-5 | Under the conditions of
the test, non-cytotoxic | Pass |
| Skin sensitization Test | Estimate the potential for contact
sensitization following ISO 10993-10 | Under the conditions of
the test, not a
sensitizer | Pass |
| Skin Irritation Test | Estimate the irritation potential of
medical device following ISO 10993-10 | Under the conditions of
the 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.
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**Source:** [https://fda-staging.innolitics.com/device/K232968](https://fda-staging.innolitics.com/device/K232968)
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