Data / Medical devices / China / Xiantao Rayxin Medical Products Co., Ltd.

Xiantao Rayxin Medical Products Co., Ltd.: FDA-registered device maker in XIANTAO Hubei, China, 5 510(k) clearances

Name: Xiantao Rayxin Medical Products Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Xiantao Rayxin Medical Products Co., Ltd. is registered with the FDA (registration 3006113262) in XIANTAO Hubei, China. It lists 18 device types. The FDA files 5 510(k) clearances under its listings, the newest dated January 16, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3006113262
Address: No.258 Pengchang Road Middle Street, XIANTAO Hubei, China, 433018
Owner or operator: XIANTAO RAYXIN MEDICAL PRODUCTS CO., LTD. (9089380)
Roles: Contract manufacturer, Manufacturer
First device listed: July 13, 2006
Registered through: 2026
Brand names listed: ForSure Apron Disposable PE, ForSure Face Mask with Earloop, ForSure Face Mask with Tie, ForSure Face Mask with Tie and Shield, ForSure Holder, Catheter, Foley, ForSure Isolation Gown, ForSure Nurses Cap, ForSure Shoe Covers Non-Skid and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Aid, Transfer	IKX	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bandage, Cast	ITG	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Device, Fixation, Tracheal Tube	CBH	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Examination	FME	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Gown, Surgical	FYA	2	Manufacturer	accessdata.fda.gov
Holder, Ureteral Catheter	EYJ	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Lift, Patient, Non-Ac-Powered	FSA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Mask, Surgical	FXX	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Shoes, Operating-Room	FXW	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Sling, Arm	ILI	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Stocking, Medical Support (For General Medical Purposes)	FQL	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Contract manufacturer, Manufacturer	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
January 16, 2019	K173847	Disposable Ultra Reinforced Surgical Gown	FYA	Substantially Equivalent	Xiantao Rayxin Medical Products Co., Ltd.	accessdata.fda.gov
June 15, 2016	K153496	Disposable Surgical Face Mask	FXX	Substantially Equivalent	Xiantao Rayxin Medical Products Co., Ltd.	accessdata.fda.gov
March 26, 2007	K070407	DUKAL SURGICAL FACE MASK TIE, EAR LOOP, WITH SHIELD YELLOW & WHITE; ANTI FOG TIE, LOOP, SHIELD, YELLOW, WHITE, AND BLUE	FXX	Substantially Equivalent	Dukal Corp.	accessdata.fda.gov
August 23, 1999	K991559	MEDLINE PROHIBIT SERIES SURGICAL MASK WITH FLUID SHIELD	FXX	Substantially Equivalent	Medline Industries, Inc.	accessdata.fda.gov
May 2, 1994	K931580	DISPOSABLE SURGICAL MASK (MODIFIED)	FXX	Substantially Equivalent	Bam Corp., Ltd.	accessdata.fda.gov

Compare with other makers

Updated January 16, 2019. 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.