K211771 - The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Surgical Procedure KF Mask, The GOOD Super Guard Design High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Mask, The KOEASY High Fluid-Resistant Surgical Procedure KF Mask, The KOEASY Super Guard Design High Fluid-Resistant Surgical Mask (FDA 510(k) Clearance)

K211771 is an FDA 510(k) clearance for the The GOOD High Fluid-Resistant Surgical Mask, The GOOD High Fluid-Resistant Su.... Classified as Mask, Surgical (product code FXX), Class II - Special Controls.

Submitted by The Good Corporation (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on August 24, 2022 after a review of 442 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

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