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510(k) K180764

TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant) by Church & Dwight Co., Inc. — Product Code NUC

K180764 is an FDA 510(k) premarket notification submitted by Church & Dwight Co., Inc. for the device "TrojanTM Azul Personal Lubricant (H2O Sensitive Touch Personal Lubricant)". The FDA issued a decision of Substantially Equivalent on August 1, 2018. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Church & Dwight Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 1, 2018
Date Received
March 23, 2018
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 Church & Dwight Co., Inc.

  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K240379 — TROJAN SIS Synthetic Latex Condom with Silicone Lubricant (October 8, 2024)
  • K221906 — TROJAN Fire & Ice lubricated male natural rubber latex condom (September 28, 2022)
  • K221431 — TROJAN(TM) Her Pleasure Warming male natural rubber latex condom with warming lu (July 14, 2022)
  • K203818 — Replens Long-Lasting Vaginal Moisturizer (June 11, 2021)
  • K193450 — Pre-Seed™ Fertility Lubricant (July 23, 2020)
  • K180104 — Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant (March 14, 2018)
  • K171639 — Trojan Supra Lubricated Polyurethane Male Condom (August 1, 2017)
  • K161915 — Trojan XOXO Ribbed Male Natural Rubber Latex Condom with Silicone and Aloe Lubri (September 9, 2016)
  • K161544 — Trojan Chain Reaction Personal Lubricant (August 31, 2016)

Other clearances for product code NUC

  • 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)
  • K253983 — Water-based lubricant (March 6, 2026)
  • K251011 — Chiavaye Personal Moisturizer (December 19, 2025)

FDA data resources