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510(k) K063385

DUREX PLAY MASSAGE GEL LUBRICANT by Ssl Americas, Inc. — Product Code NUC

K063385 is an FDA 510(k) premarket notification submitted by Ssl Americas, Inc. for the device "DUREX PLAY MASSAGE GEL LUBRICANT". The FDA issued a decision of Substantially Equivalent on March 10, 2008. The device falls under product code NUC (Lubricant, Personal), a Class II device regulated under 21 CFR 884.5300. Ssl Americas, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2008
Date Received
November 8, 2006
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 Ssl Americas, Inc.

  • K072169 — DUREX SYNTHETIC POLYISOPRENE MALE CONDOM (June 19, 2008)
  • K072236 — DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT (May 7, 2008)
  • K071626 — DUREX PLAY SOFT & SENSUAL LUBRICANT (April 1, 2008)
  • K060098 — DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS (June 8, 2006)
  • K052959 — DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS (January 27, 2006)
  • K042958 — DUREX PLAY TINGLING LUBRICANT (April 8, 2005)
  • K042470 — DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDO (April 5, 2005)
  • K042563 — DUREX PLAY WARMER LUBRICANT (February 23, 2005)
  • K042957 — DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT (February 17, 2005)
  • K040185 — DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM (April 27, 2004)

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