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510(k) K220273

Onetouch Non-paraben Lubricant Gel by Thai Nippon Rubber Industry Public Company Limited. — Product Code NUC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 2022
Date Received
January 31, 2022
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 Thai Nippon Rubber Industry Public Company Limited.

  • K210095 — Playboy Premium Silicone Lubricant (November 23, 2021)
  • K211450 — Playboy 3 Contour Condom (September 30, 2021)
  • K210294 — One Touch Spiral Condom (September 23, 2021)
  • K171213 — One Touch Condom with Benzocaine (January 12, 2018)

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  • K242712 — LubriZenzs (June 4, 2025)
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  • K250629 — Sutil Rich Personal Lubricant (May 2, 2025)