Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009233038

FEI Number

3009233038

Entity Name

BLUE SAIL (HONG KONG) TRADING LIMITED

City/State/Country

Harbour, HK

Establishment Address

Room 1401, 14/F, Wold Commerce Center,, 7-11 Canton Rd.,Tsim Sha Tsui, Harbour 00000, HK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

BLUE SAIL (HONG KONG) TRADING LIMITED (Owner Number: 10039181)

Owner / Operator Contact Address

Room 1401, 14/F, Wold Commerce Center,, 7-11 Canton Rd.,Tsim Sha Tsui, Harbour, HK-NOTA 00000, HK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

N95 face mask Disposable medical mask KN95 face mask Disposable protective mask Face Shield, Safety Goggle, Spectacles Mob Cap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2020-04-17
FME	Gown, Examination	General Hospital	Class 1	880.6265	2020-03-31
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-13
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2020-04-15
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2020-03-31
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2011-12-15
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2020-03-31
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-03-25
IWO	Apron, Protective	Radiology	Class 1	892.6500	2020-03-31
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-31
BWP	Shoe And Shoe Cover, Conductive	General, Plastic Surgery	Class 1	878.4040	2020-07-13
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-03-31
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2020-07-13

Official Correspondent

Chuanzhi Sun

US Agent Details

Renee Rees Business: Omni International Corp Email: rrees@omnigloves.com Phone: (603) 4711499

Related Public Records

Same Entity

BLUE SAIL (HONG KONG) TRADING LIMITED

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K102092	Prestige Ameritech	PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES	2010-10-06
K052612	Shanghai Antares Industries, Inc.	DISPOSABLE POWDER FREE VINYL EXAM GLOVES WITH VITAMIN COMPLEX, NOPAL AND LANOLIN BLUE COLOR	2005-11-22
K120584	Wealth on (Jiangsu) Co., Ltd.	POWER FREE STRETCH VINYL PATIENT EXAMINATION GLOVES	2012-07-10
K220992	Ever Global (Vietnam) Enterprise Corporation	Disposable Powder Free Vinyl Exam Glove, Black/Blue/Purple	2022-10-19
K112610	Inpro Technology Device Factory	SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE (AND MULTIPLE LABELS)	2011-12-05

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009233038. Last updated year: 2026. Please use registration number 3009233038 when referencing this establishment in official correspondence.