Cleared Traditional

K232968 - Grande Medical Masks

K232968 is an FDA 510(k) clearance for Grande Medical Masks, manufactured by Golden Grande Corp.. The device is a Class 2 General Hospital device with product code FXX cleared through the Traditional 510(k) pathway after a 259-day FDA review.

K232968 · Golden Grande Corp. · General Hospital
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Jun 2024
Decision
259d
Days
Class 2
Risk

K232968 is an FDA 510(k) clearance for the Grande Medical Masks, Model SF-600. Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by Golden Grande Corp. (Tianan, TW). The FDA issued a Cleared decision on June 6, 2024 after a review of 259 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Golden Grande Corp. devices

FDA 510(k) Submission Details - K232968

510(k) Number K232968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 21, 2023
Decision Date June 06, 2024
Days to Decision 259 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 129d · This submission: 259d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FXX Device Classification - Class 2, Special Controls

Product Code FXX Mask, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - FXX Mask, Surgical

All 452
Devices cleared under the same product code (FXX) and FDA review panel - the closest regulatory comparables to K232968.
Fluidshield* 1 Procedure Mask with SO SOFT* Lining and SO SOFT Earloops (25869)
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HALYARD* FLUIDSHIELD* 1 Procedure Mask with So Soft Lining and So Soft Earloops (25867)
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