Data / Medical devices / Hong Kong / Blue Sail (hong Kong) Trading Limited

Blue Sail (hong Kong) Trading Limited: FDA-registered device maker in Harbour, Hong Kong, 2 510(k) clearances

Name: Blue Sail (hong Kong) Trading Limited FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Blue Sail (hong Kong) Trading Limited is registered with the FDA (registration 3009233038) in Harbour, Hong Kong. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 10, 2011. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3009233038
Address: Room 1401, 14/F, Wold Commerce Center, 7-11 Canton Rd.,Tsim Sha Tsui, Harbour, Hong Kong, 00000
Owner or operator: BLUE SAIL (HONG KONG) TRADING LIMITED (10039181)
Roles: Exporter to the US, Specification developer
First device listed: December 15, 2011
Registered through: 2026
Brand names listed: Disposable medical mask, Disposable protective mask, Face Shield, Safety Goggle, Spectacles, KN95 face mask, Mob Cap, N95 face mask

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Exporter to the US, Specification developer	accessdata.fda.gov
Apron, Protective	IWO	1	Exporter to the US	accessdata.fda.gov
Cap, Surgical	FYF	1	Exporter to the US	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Exporter to the US, Specification developer	accessdata.fda.gov
Gown, Examination	FME	1	Exporter to the US, Specification developer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Exporter to the US	accessdata.fda.gov
Mask, Scavenging	KHA	1	Exporter to the US, Specification developer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Exporter to the US, Specification developer	accessdata.fda.gov
Respirator, Surgical	MSH	2	Exporter to the US, Specification developer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Exporter to the US	accessdata.fda.gov
Shoe And Shoe Cover, Conductive	BWP	1	Exporter to the US	accessdata.fda.gov
Vinyl Patient Examination Glove	LYZ	1	Exporter to the US	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 10, 2011	K110314	STRETCH VINYL EXAMINATION GLOVE, POWDER FREE (YELLOW/WHITE/CLEAR(NON-COLORED)	LYZ	Substantially Equivalent	True Glove Factory	accessdata.fda.gov
May 8, 2009	K090513	VINYL EXAMINATION GLOVE, POWDER FREE CLEAR (NON-COLORED)	LYZ	Substantially Equivalent	Shandong Huayue Glove Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated May 10, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.