Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3004134948

FEI Number

3004134948

Entity Name

ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.

City/State/Country

Huzhou City Zhejiang, CN

Establishment Address

18 Xinlian Street, Xinshi Town, Deqing County, Huzhou City Zhejiang 313201, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD. (Owner Number: 9058200)

Owner / Operator Contact Address

18 Xinlian Street, Xinshi Town, Deqing County, Huzhou City, CN-ZJ 313201, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NON SURGICAL MEDICAL MASK NON SURGICAL DUST MASK NON SURGICAL PARTICLE RESPIRATOR EYE SHIELD PROTECTION SHIELD FACE SHIELD NON SURGICAL FACE MASK Venturi Mask with 6 Diluter Jets POWDER -FREE PATIENT EXAMINATION GLOVES OXYGEN MASK(WITH OPTIONAL OXYGEN TUBE, NEBULIZER,AIR BAG, CHAMBER OR VALVES) Non-Rebreathing Mask with 2M Tube Suction Catheter Kit NEBULIZER/NEBULIZER KIT/NEBULIZERS MULTIPLE (AEROSOL DRAINAGE SYSTEM) Humidifier CORRUGATED TUBING SUCTION CATHETER, COILED

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2020-04-01
BYF	Mask, Oxygen, Low Concentration, Venturi	Anesthesiology	Class 1	868.5600	2019-02-17
LYZ	Vinyl Patient Examination Glove	General Hospital	Class 1	880.6250	2024-12-27
BYG	Mask, Oxygen	Anesthesiology	Class 1	868.5580	2007-11-06
KGB	Mask, Oxygen, Non-Rebreathing	Anesthesiology	Class 1	868.5570	2019-02-17
OFR	Tracheobronchial Suction Catheter Kit	Anesthesiology	Class 1	868.6810	2024-12-27
CCQ	Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	Anesthesiology	Class 1	868.5640	2007-11-06
BTC	Bag, Reservoir	Anesthesiology	Class 1	868.5320	2006-05-09
KFZ	Humidifier, Non-Direct Patient Interface (Home-Use)	Anesthesiology	Class 1	868.5460	2020-09-25
BZO	Set, Tubing And Support, Ventilator (W Harness)	Anesthesiology	Class 1	868.5975	2003-08-21
BSY	Catheters, Suction, Tracheobronchial	Anesthesiology	Class 1	868.6810	2003-08-21

Official Correspondent

No official correspondent registered.

US Agent Details

Charles Mack Business: IRC USA Email: ircfda@gmail.com Phone: (931) 6254938

Related Public Records

Same Entity

ZHEJIANG BAITE MEDICAL APPLIANCES CO., LTD.

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
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
K131340	Made Plastic Co., Ltd.	POWDER FREE YELLOW SYNTHETIC VINYL PATIENT EXAMINATION GLOVES	2014-09-09

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-2026	Percussionaire Corporation	1	Phasitron 5, IPV In-Line Valve, (Intrapulmonary Percussive Ventilation) REF: P5-TEE-20 (pack of 20)/ P5-TEE (individual) with In-Line Valve Sentec Instructions for Use

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3016871880	PRIMEX DESIGN & FABRICATION	Richmond, IN, US
3005360866	QEL DOMINICANA S.A.	ESPERANZA Valverde, DO
3010601984	Jiangsu Haize Medical Scientific Development Co.,Ltd.	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004134948. Last updated year: 2026. Please use registration number 3004134948 when referencing this establishment in official correspondence.