FDA cleared the Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong from Taizhou Huangyan Guanhong Plastic Steel Products Factory on May 22, 2026 under K253773, a traditional 510(k). The device falls under product code MMK, Container, Sharps, regulated at 21 CFR 880.5570 as a Class 2 device. The review panel was General Hospital.
FDA logged the submission as received on Nov 26, 2025. The decision came 177 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for Taizhou Huangyan Guanhong Plastic Steel Products Factory in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K253773?
K253773 is the FDA 510(k) for Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong, submitted by Taizhou Huangyan Guanhong Plastic Steel Products Factory. FDA's decision date was May 22, 2026, under product code MMK (Container, Sharps).
Who makes the Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong Sharps Container (GH-6FA); Guanhong Sharps Container (GHW-2FR); Guanhong Sharps Container (GHW-8FR); Guanhong Sharps Container (GH-3FS); Guanhong Sharps Container (GHW-15FS); Guanhong Sharps Container (GHW-27FS); Guanhong Sharps Container (GH-5FSW); Guanhong Sharps Container (GHW-3FT); Guanhong Sharps Container (GHW-4FT); Guanhong Sharps Container (GHW-5FT); Guanhong Sharps Container (GHW-8FT); Guanhong?
Taizhou Huangyan Guanhong Plastic Steel Products Factory, based in Taizhou, is the applicant of record for K253773.
How long did the K253773 review take?
FDA received the submission on Nov 26, 2025 and issued its decision on May 22, 2026, 177 days later.