Home / 510(k) Clearances / K190858

510(k) K190858

Bucked Stride Silicone Lubricant, #LubeLife Thin Silicone Lubricant, JO XTRA SILKY Ultra-Thin Silicone Personal Lubricant by United Consortium — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 2019
Date Received
April 2, 2019
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.

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  • K182105 — JO Naturalove Personal Lubricant, JO Naturalove Strawberry Fields Flavored Perso (November 14, 2018)
  • K181408 — JO Classic Hybrid Personal Lubricant (August 27, 2018)
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  • K180219 — JO H2O Flavored Personal Lubricants (April 20, 2018)
  • K180083 — Silicone Personal Lubricant, ALL-IN-ONE (April 9, 2018)

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