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510(k) K122476

LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT by Ansell Healthcare Products, LLC — Product Code NUC

K122476 is an FDA 510(k) premarket notification submitted by Ansell Healthcare Products, LLC for the device "LIFESTYLES SMOOTH 2-IN-1 MASSAGE & LUBRICANT". The FDA issued a decision of Substantially Equivalent on March 7, 2013. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Ansell Healthcare Products, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2013
Date Received
August 14, 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

  • K253989 — HARU Orgasm by jack herer water based lubricant (WL-OJ); HARU Orgasm water based (September 3, 2026)
  • K261905 — BUM Oil (August 7, 2026)
  • K261177 — PINKSLIP Water-Based Personal Lubricant and Moisturizer (July 9, 2026)
  • K261909 — Plum Vagiceuticals™ Vaginal Moisturizing Suppositories (July 6, 2026)
  • K254011 — Flow Water-Based Personal Lubricant (June 22, 2026)
  • K261292 — PR Water-Base Lube Personal Lubricant (PR Water-Base Lube Personal Lubricant) (June 11, 2026)
  • K252914 — Sutil Pure Personal Lubricant (models 1148, 1145, 1146, 1147) (June 9, 2026)
  • K260068 — pjur NATURE Touch, 100 ml (May 21, 2026)
  • K254101 — Julva Velvé Water-Based Personal Lubricant (April 16, 2026)
  • K260007 — Hyaluronic Acid Vaginal Suppository (HA 5 mg); Hyaluronic Acid Vaginal Supposito (April 1, 2026)

FDA data resources