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Paragon Packaging Incorporated: FDA-registered device maker in Old Bridge, NJ, United States, 11 510(k) clearances

Name: Paragon Packaging Incorporated FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Paragon Packaging Incorporated is registered with the FDA (registration 1000136042) in Old Bridge, NJ, United States. It lists 4 device types. The FDA files 11 510(k) clearances under its listings, the newest dated December 6, 2018. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 1000136042
Address: 200 Fairway Lane, Old Bridge, NJ, United States, 08857
Owner or operator: Paragon Packaging Incorporated (10044101)
Roles: Repackager or relabeler
First device listed: April 30, 2013
Registered through: 2027
Brand names listed: Condom

Devices it lists

Device	Product code	Class	Role	Source
Condom	HIS	2	Repackager or relabeler	accessdata.fda.gov
Condom With Nonoxynol-9	LTZ	2	Repackager or relabeler	accessdata.fda.gov
Condom, Synthetic	MOL	2	Repackager or relabeler	accessdata.fda.gov
Tampon, Menstrual, Unscented	HEB	2	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
December 6, 2018	K182438	Synthetic Polyisoprene Lubricated Male Condom - 5 senses	MOL	Substantially Equivalent	Sxwell USA, LLC	accessdata.fda.gov
August 2, 2017	K171172	Skyn Original Polyisoprene Lubricated Male Condom - Flavored	MOL	Substantially Equivalent	Ansell Healthcare Products, LLC	accessdata.fda.gov
January 23, 2017	K163107	Lifestyles Zero Lubricated Latex Male Condom	HIS	Substantially Equivalent	Ansell Healthcare Products, LLC	accessdata.fda.gov
July 25, 2016	K160399	Skyn Original Polyisoprene Lubricated Male Condom	MOL	Substantially Equivalent	Ansell Healthcare Products, LLC	accessdata.fda.gov
March 21, 2013	K130609	VEEDA 100% COTTON MENSTRUAL TAMPON	HEB	Substantially Equivalent	Naturalena Brands, Inc.	accessdata.fda.gov
April 29, 2009	K091084	MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS	HEB	Substantially Equivalent	Cotton High Tech S.L.	accessdata.fda.gov
February 18, 2009	K080733	COTTONS 100% NATURAL COTTON TAMPONS	HEB	Substantially Equivalent	Cottons Pty, Ltd.	accessdata.fda.gov
April 27, 2001	K010371	LIFESTYLES, CONTEMPO OR PRIVATE LABEL, MALE LATEX CONDOM WITH GLYCERINE LUBRICANT	HIS	Substantially Equivalent	Suretex, Ltd.	accessdata.fda.gov
July 31, 2000	K001883	LIFESTYLES, CONTEMPO OR PRIVATE LABEL LARGE CONDOM	HIS	Substantially Equivalent	Ansell Healthcare, Inc.	accessdata.fda.gov
April 19, 2000	K000408	LIFESTYLES, CONTEMPO OR PRIVATE LABEL STRAWBERRY, VANILLA, OR BANANA FLAVORED CONDOM	HIS	Substantially Equivalent	Suretex Prophylactics , Ltd.	accessdata.fda.gov
December 6, 1995	K941258	LATEX CONDOM	HIS	Substantially Equivalent	Suretex, Ltd.	accessdata.fda.gov

Compare with other makers

Updated December 6, 2018. 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.