FDA.reportPublic FDA data

KY True Feel Deluxe Personal Lubricant

Primary DI
77067981096745
Brand
KY True Feel Deluxe Personal Lubricant
Company
RB Health (us) LLC
Model
Personal Lubricant
Device description
Personal Lubricant
Published
2019-11-13
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUCLubricant, personal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUCLubricant, PersonalObstetrics/Gynecology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173504000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173504000K-Y SiliconeReckitt Benckiser, LLC2018-01-12NUC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
77067981096745PackageGS112Not in Commercial Distribution
88067981096741PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
7706798109674577067981096745
8806798109674188067981096741

GMDN Terms#

Term, Definition table
TermDefinition
Vaginal lubricantA non-sterile substance (e.g., a gel or jelly) designed to lubricate the vagina to facilitate entry of a gloved finger(s) or a device, e.g., a vaginal speculum, during a diagnostic or therapeutic treatment. This substance will be compatible to the sensitive mucous and tissue of this area. After application, this device cannot be reused.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool dry place away from direct sunlight

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)756-5488xxx@xxx.xxx

Regulatory Flags#

DUNS number
081049410
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
50302340996131Durex Intense003023409961362026-03-02
00067981087956KY Personal Lubricant Jelly000679810890282025-12-09
00067981087963KY Personal Lubricant Jelly000679810891272025-12-09
10067981088059KY Warming Jelly 000679810894792025-12-09
10067981088042KY Warming Jelly 000679810894862025-12-09
10067981993698KY Personal Lubricant Jelly000679819936912025-12-09
10067981993964KY Natural Feeling with Hyaluronic Acid000679819939672025-12-09
10067981993971KY Natural Feeling with Hyaluronic Acid000679819939742025-12-09
10067981993988KY Natural Feeling with Aloe Vera Lubricant000679819939812025-12-09
00067981087253KY Intense CondomsCondom2019-05-30
00067981087260KY Intense CondomsCondom2019-05-30
00067981087277KY Intense CondomsCondom2019-10-14
00067981087758KY Extra Lubricated CondomsCondom2019-06-12
00067981087765KY Intense CondomsCondom2019-06-12
00067981941845KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981962161KY Touch 2-in-1 Massage Creme & Pleasure GelPersonal Lubricant2016-09-20
00067981087925KY UltraGel Personal Lubricant000679810873522016-09-20
00067981087932KY UltraGel Personal Lubricant000679810873762016-09-20
00067981963038KY Natural Feeling with Botanical Essence Lubricant & Massage GelPersonal Lubricant2018-10-31
00067981087178KY Extra Lubricated CondomsCondom2018-10-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06974586081637BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-08-19
06979879080199RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080205RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080212RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080229RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080366RawTouchShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080373HANIDOLLShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080380TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
06979879080397Wet StuffShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-08-14
00860002995304HYDRADOSEMD LABS LLCNUC2026-08-01
06936684210333S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210340S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
06936684210357S Shock SharkGuangzhou Haoyimai Trading Co., Ltd.NUC2026-07-30
00855859003319ViaSolv Wellness, LLCNUC2026-07-29
00850026643275Rock CandyPRIVATE LABEL PRODUCTIONS LLCNUC2026-07-17
00198715540161LavaLava IntimatesNUC2026-07-14
06974586081675BEISAR, Water Solubility Human Body LubricantDongguan Yanxuan Biotechnology Co., Ltd.NUC2026-07-14
00199284921726Urge Silicone Personal LubricantUrge Cream LLCNUC2026-07-08
00827160117436pjur NATURE TouchPjur Group Luxembourg SANUC2026-07-03
06979879080236ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080250ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080267ArousellubeShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080298Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080304Oye JoyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080311TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080328TantalyShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
06979879080342SyronosShenzhen Yongquan Medical Devices Co., Ltd.NUC2026-07-03
00796494006191Kindra - Water-based Lubricant - 3.4ozCC Wellness LLCNUC2026-06-10
20726893120482Mixed PleasureGLOBAL PROTECTION CORP.NUC2026-06-04
00796494006160Williams-Trading/Cloud 9 Water-Based 4ozCC Wellness LLCNUC2026-06-02