Data / Medical devices / China / Foshan Niceday Sanitary Products Co., Ltd.

Foshan Niceday Sanitary Products Co., Ltd.: FDA-registered device maker in Foshan Guangdong, China, 8 510(k) clearances

Name: Foshan Niceday Sanitary Products Co., Ltd. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Foshan Niceday Sanitary Products Co., Ltd. is registered with the FDA (registration 3015391081) in Foshan Guangdong, China. It lists 19 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 30, 2022. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3015391081
Address: 602-1,T4 Poly, No.8 Wenhua South RD, Dongping New Town, Lecong Town Shunde District, Foshan Guangdong, China, 528315
Owner or operator: Foshan Niceday Sanitary Products Co., Ltd. (10060788)
Roles: Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
First device listed: June 24, 2019
Registered through: 2026
Brand names listed: Adult diaper, Baby diaper, Body warmer pad, CAP, COVER, Cold pack, DISPOSABLE NON WOVEN CAP, DISPOSABLE SMS CAP and more

Devices it lists

Device	Product code	Class	Role	Source
Accessory, Surgical Apparel	LYU	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cap, Surgical	FYF	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Cover, Shoe, Operating-Room	FXP	1	Exporter to the US	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Contract manufacturer, Exporter to the US	accessdata.fda.gov
Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua	QKR	N	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Garment, Protective, For Incontinence	EYQ	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Lens, Spectacle, Non-Custom (Prescription)	HQG	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Lubricant, Personal	NUC	2	Exporter to the US	accessdata.fda.gov
Mask, Scavenging	KHA	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Nursing Pad, Polyurethane Pad With Starch Copolymer, Glycerin, And Surfactant (F-68)	NTX	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Exporter to the US	accessdata.fda.gov
Pad, Menstrual, Unscented	HHD	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Radiographic Protective Glove	IWP	1	Exporter to the US	accessdata.fda.gov
Respirator, Surgical	MSH	2	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Suit, Surgical	FXO	1	Contract manufacturer, Exporter to the US, Manufacturer	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	Exporter to the US, Repackager or relabeler	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
September 30, 2022	K222046	Unscented Menstrual Tampon	HEB	Substantially Equivalent	Suzhou Borage Medical Technology Co., Ltd.	accessdata.fda.gov
December 23, 2020	K203257	LUBi Water Based Personal Lubricant	NUC	Substantially Equivalent	Boya Biotechnology Co., Ltd.	accessdata.fda.gov
December 20, 2019	K191666	Unscented W long plastic and cardboard applicator tampons	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
March 3, 2017	K162746	Ontex and other proprietary names	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
June 23, 2015	K142786	Ontex Unscented Tampons with Colored Plastic Applicators	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
April 23, 2014	K132595	ONTEX ROLL WADDING PLASTIC APPLICATOR COMPACT SIZE UNSCENTED TAMPONS	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
December 19, 2012	K122603	ONTEX AND OTHER PROPRIETARY NAMES	HEB	Substantially Equivalent	Ontex Bvba	accessdata.fda.gov
December 23, 2009	K090819	ONTEX TAMPON (UNSCENTED)	HEB	Substantially Equivalent	Ontex International NV	accessdata.fda.gov

Compare with other makers

Updated September 30, 2022. 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.