Data / Medical devices / United States / Rondo-Pak

Rondo-Pak: FDA-registered device maker in Camden, NJ, United States, 10 510(k) clearances

Name: Rondo-Pak FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Rondo-Pak is registered with the FDA (registration 3013770781) in Camden, NJ, United States. It lists 4 device types. The FDA files 10 510(k) clearances under its listings, the newest dated October 27, 2023. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3013770781
Address: 1200 Ferry Ave, Camden, NJ, United States, 08104
Owner or operator: Rondo-Pak (10087400)
Roles: Repackager or relabeler
First device listed: February 22, 2023
Registered through: 2026
Brand names listed: LifeStyles (Flavors & Colors), LifeStyles Large, LifeStyles Non-Lubricated, Lifestyles Closer Connection, Lifestyles Snugger Fit, Lifestyles Ultra Sensitive, SKYN All Night Long, SKYN Cocktail Club and more

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
Lubricant, Personal	NUC	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
October 27, 2023	K231908	45 Micron Polyisoprene Condom	MOL	Substantially Equivalent	Suretex Limited	accessdata.fda.gov
September 30, 2022	K221243	OFNat Lubricant (L15)	NUC	Substantially Equivalent	Suretex Limited	accessdata.fda.gov
April 28, 2022	K213921	Microthin Natural Rubber Latex Condom	HIS	Substantially Equivalent	Suretex Limited	accessdata.fda.gov
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
February 19, 2013	K122477	LIFESTYLES LUXE PREMIUM PERSONAL LUBRICANT	NUC	Substantially Equivalent	Ansell Healthcare Products, LLC	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
January 30, 1995	K940046	NON-LUBRICATED CONDOM	HIS	Substantially Equivalent	Ansell, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 27, 2023. 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.