Home / 510(k) Clearances / K122054

510(k) K122054

LIFESTYLES NATURAL PERSONAL LUBRICANT by Ansell Healthcare Products, LLC — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 14, 2013
Date Received
July 13, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lubricant, Personal
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

This device is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product may or may not be compatible with natural rubber latex, polyisoprene, and/or polyurethane condoms.

Other clearances by Ansell Healthcare Products, LLC

  • K230079 — Polyisoprene Surgical Gloves Tested for Use with Chemotherapy Drugs and Low Derm (August 23, 2023)
  • K213289 — Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs (May 26, 2023)
  • K212148 — Non-Sterile Powder-Free Polychloroprene Examination Glove (Blue) Tested for Use (March 10, 2022)
  • K210401 — Microflex Nitrile Patient Examination Gloves Blue Colored Tested for Use with Ch (June 13, 2021)
  • K200671 — Microflex Nitrile Patient Examination Gloves with Aloe and Chamomile Blue Green (June 19, 2020)
  • K190018 — Gammex Non Latex PI White Polyisoprene Surgical Gloves Tested for Use with Chemo (May 23, 2019)
  • K182948 — Gammex PI Hybrid Surgical Gloves Tested for Use with Chemotherapy Drugs (March 22, 2019)
  • K171375 — Gammex PI Breach Detect Powder Free Surgical Glove (February 6, 2018)
  • K171737 — Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves (December 29, 2017)
  • K171172 — Skyn Original Polyisoprene Lubricated Male Condom - Flavored (August 2, 2017)

Other clearances for product code NUC

  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)
  • K252935 — Hybrid personal lubricant (water&silicone) (5ml, 8ml, 10ml, 12ml, 15ml, 20ml, 30 (December 15, 2025)
  • K250488 — Cerynë Intimate Care (December 12, 2025)
  • K251773 — Water-soluble Personal Lubricant (Satin Gel Vitamin E flavor lubricant; Satin G (September 9, 2025)
  • K250142 — Water-based Lubricant (August 8, 2025)
  • K243972 — Plain Water-based Lubricant (August 8, 2025)
  • K242712 — LubriZenzs (June 4, 2025)
  • K243107 — Water Solubility Human Body Lubricant (May 9, 2025)
  • K250629 — Sutil Rich Personal Lubricant (May 2, 2025)