K253773 - Guanhong Sharps Container (GHW-1F1) (FDA 510(k) Clearance)

K253773 is an FDA 510(k) clearance for the Guanhong Sharps Container (GHW-1F1). Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Taizhou Huangyan Guanhong Plastic Steel Products Factory (Taizhou, CN). The FDA issued a Cleared decision on May 22, 2026 after a review of 177 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - 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.

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