# K253222: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)

- Pathway: 510(k) (Traditional)
- Applicant: Zhejiang Gongdong Medical Technology Co., Ltd.
- Decided: Dec 22, 2025 after 84 days
- Product code: MMK (Container, Sharps)
- Device class: 2
- Regulation: 21 CFR 880.5570
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K132767 (2014). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222905: Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT Sharps Container, MA1212), Maxcon Sharps Container (5.4 QT Sharps Container, MA1213), Maxcon Sharps Container (7 Liter Sharps Container, MA1324), Ningbo Maxcon Medical Technology Co., Ltd. (2023) Summary page 6.
- K180984: Maxcon Sharps Container, Ningbo Maxcon Medical Technology Co., Ltd. (2019) Summary page 6.

## Indications for use
Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The Containers are single-use, disposable, non-sterile containers intended to be used for health- care purposes for safe disposal of hazardous sharps such as needles, syringes, lancets and etc. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.

Source page: https://510kreport.com/device/K253222
Methodology: https://510kreport.com/methodology