# K063334: Shanghai Ganghai Model Giko 1400

- Pathway: 510(k) (Abbreviated)
- Applicant: Shanghai Gangkai Purifying Products Co., Ltd.
- Decided: Dec 8, 2006 after 32 days
- Product code: MSH (Respirator, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K050193 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050193: Gerson 2130/31 Type N95 Niosh Certified Surgical Respirator, Louis M. Gerson Co., Inc. (2005) Summary page 1.

## Indications for use
The Shanghai Ganghai Type N95 Healthcare Particulate Respirator and Surgical Mask Model GIKO 1400 is intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. This device also meets CDC Guidelines for TB Exposure Control.

Source page: https://510kreport.com/device/K063334
Methodology: https://510kreport.com/methodology