Guanhong Sharps Container (13+ models)— 510(k) K253773

Substantially Equivalent

Taizhou Huangyan Guanhong Plastic Steel Products Factory

FDA 510(k) clearance K253773 for Guanhong Sharps Container (13+ models), Substantially Equivalent on 2026-05-22. Applicant: Taizhou Huangyan Guanhong Plastic Steel Products Factory. Device class: 2.

Summary

Taizhou Huangyan Guanhong Plastic Steel Products Factory's record covers a list of Guanhong Sharps Container models, starting with GHW-1F1, GHW-1F4 and GH-6FA. The device name in the record is cut off partway through that list. The product code is MMK, sharps containers.

Class II, 21 CFR 880.5570. General Hospital is both the classification panel and the review panel, and the submission was a Traditional 510(k).

Guanhong filed from Taizhou, China. The decision came 177 calendar days after receipt (November 26, 2025 to May 22, 2026).

Clearance details

Device name as filed
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
Applicant
Taizhou Huangyan Guanhong Plastic Steel Products Factory
Product code
Product code MMK
Device class
Class 2
Regulation
21 CFR 880.5570
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Taizhou, CN
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