Fitone Latex Products Co., Ltd. Guangdong FDA Approvals

0 new drug approvals and 4 device clearances on file. This applicant is not matched to a listed company.

Newest first

A new drug approval is an original application; a 510(k) is a device shown equivalent to one already sold.

Product	What it is	Route	Decided
Single-Use Latex Sterile Surgical Gloves (SG100)510(k)Sep 22, 2023General, Plastic Surgery	General, Plastic Surgery	510(k)Substantially Equivalent (Traditional)	Sep 22, 2023
Nitrile Patient Examination Gloves Tested For Use With Chemotherapy Drugs510(k)Dec 1, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Dec 1, 2022
Single-use medical latex examination gloves (LG100)510(k)Sep 24, 2022General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Sep 24, 2022
Nitrile examination gloves510(k)Oct 12, 2021General Hospital	General Hospital	510(k)Substantially Equivalent (Traditional)	Oct 12, 2021