Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011015568

FEI Number

3011015568

Entity Name

Reckitt Benckiser LLC

City/State/Country

Nutley, NJ, US

Establishment Address

100 Metro Blvd, Nutley, NJ 07110, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

Owner / Operator

Reckitt Benckiser LLC (Owner Number: 9004884)

Owner / Operator Contact Address

100 Metro Blvd, Nutley, NJ 07110, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K183302

PMA Number

N/A

All Registered Proprietary Names

Durex Adventure Pack Durex Performax® Intense Durex Prolong Durex Pleasure Pack Durex Tropicals Durex Intense Sensation Durex Touch & Play Aloe Vera Massage & Pleasure Personal Lubricant Durex Massage Lube & Gel Aloe Vera Personal Lubricant Durex Juicy Play Cherry Flavored Sweeten Up Your Play Personal Lubricant Durex Juicy Play Cherry Flavored Personal Lubricant Durex Touch & Play Ylang Ylang Massage & Pleasure Personal Lubricant Durex Massage Lube & Gel Ylang Ylang Personal Lubricant TheraPearl Eye Mask (blue, color changing, pink) TheraPearl Koala TheraPearl Build Your Own Pack TheraPearl Knee Wrap with Strap (blue, color changing) TheraPearl Rabbit TheraPearl Unicorn TheraPearl Dragon TheraPearl Ankle/Wrist Wrap with Strap (blue, color changing) TheraPearl Oval TheraPearl Fox TheraPearl Pig TheraPearl Shoulder Wrap with Strap (blue, color changing) TheraPearl Shin Wrap with Strap (blue, color changing) TheraPearl Square (blue, color changing) TheraPearl Frog TheraPearl Face Mask (blue, color changing) TheraPearl Puppy TheraPearl Shark TheraPearl Sports Pack (blue, color changing) TheraPearl Pony TheraPearl Penguin TheraPearl Sports Pack with Strap (blue, color changing) TheraPearl Neck Wrap (blue, color changing) TheraPearl Round TheraPearl Panda TheraPearl Husky TheraPearl Back Wrap with Strap (blue, color changing) KY Liquibeads Durex XXL KY Hydrablend KY True Feel Durex Cheeky Play Silicone Long Lasting Personal Lubricant KY Silicone True Feel Durex Cheeky Play Silicone Long Lasting Pleasure Personal Lubricant Durex RealFeel Durex Classic Durex Air Regular Fit KY Natural Feeling Moisturizing Lubricant with Hyaluronic Acid Durex Pleasure Ring KY Warming Liquid KY Intense Durex Extra Sensitive Stimulating Durex Pleasure Pack Durex Adventure Pack KY Liquid KY Jelly KY Love Sensuality KY Yours + Mine KY Love Passion KY Tingling Durex Intense Durex Intense Ultra Lube Queen V p.s. I Lube you KY Intense Durex Intense XL KY Ultragel KY Natural Feeling with Aloe Vera

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2016-06-16
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2023-03-23
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2015-11-03
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2023-01-22
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2021-12-09
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2015-07-15
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2019-12-09
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2025-01-16
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2019-10-23
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2009-01-05
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2015-11-03
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2023-09-07
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2019-09-05
LKY	Device, External Penile Rigidity	Gastroenterology, Urology	Class 2	876.5020	2007-05-23
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2014-06-02
KYW	Container, Liquid Medication, Graduated	General Hospital	Class 1	880.6430	2015-11-16
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2008-02-26
HIS	Condom	Obstetrics/Gynecology	Class 2	884.5300	2014-06-02
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2014-06-02
KMJ	Lubricant, Patient	General Hospital	Class 1	880.6375	2010-11-17
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2014-08-18
KNP	Orthosis, Corrective Shoe	Physical Medicine	Class 1	890.3475	2017-05-24
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2010-11-17
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2024-12-18
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2015-11-16
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-12-09
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2016-01-27
MOL	Condom, Synthetic	Obstetrics/Gynecology	Class 2	884.5300	2025-07-28
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2021-02-04
NUC	Lubricant, Personal	Obstetrics/Gynecology	Class 2	884.5300	2019-09-05

Official Correspondent

Andrew Alum

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Reckitt Benckiser LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3008559248	Qingdao London Durex Co., Ltd.	Qingdao Shandong, CN
3003071219	SSL MANUFACTURING (THAILAND) LTD.	BANGSAMAK,BANGPAKONG Chachoengsao, TH
2531449	Reckitt Benckiser LLC	Harrisburg, PA, US
3010164364	Reckitt Benckiser Healthcare Manufacturing (Thailand) Ltd.	Bangplee Samut Prakan, TH

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K050212	Qualis, Inc.	PERSONAL WARMING JELLY	2005-03-17
K820587	Abco Dealers, Inc.	WET PACK LINE OF PRODUCTS	1982-03-26

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011015568. Last updated year: 2026. Please use registration number 3011015568 when referencing this establishment in official correspondence.