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510(k) K042470

DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM by Ssl Americas, Inc. — Product Code HIS

K042470 is an FDA 510(k) premarket notification submitted by Ssl Americas, Inc. for the device "DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM". The FDA issued a decision of Substantially Equivalent on April 5, 2005. The device falls under product code HIS (Condom), 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
April 5, 2005
Date Received
September 13, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom
Device Class
Class II
Regulation Number
884.5300
Review Panel
OB
Submission Type

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)
  • K063385 — DUREX PLAY MASSAGE GEL LUBRICANT (March 10, 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)
  • 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 HIS

  • K252622 — Male Latex Condom HA (May 4, 2026)
  • K252521 — LifeStyles® HydraFeel Natural Rubber Latex Condom (November 18, 2025)
  • K250034 — Natural rubber latex male condom (July 11, 2025)
  • K243421 — Lelo Hex Lubricated Natural Rubber Latex Condom (March 7, 2025)
  • K243640 — Trojan™ Ultra Ribbed Ecstasy latex condom with lubricant (Trojan™ Ultra Ribbed E (February 21, 2025)
  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K232279 — LifeStyles NRL Textured Condom (October 5, 2023)
  • K230049 — SKORE Smooth, Dotted, Thin Condoms - SKORE Blues, SKORE Belgian Chocolate, SKORE (September 7, 2023)
  • K222611 — Male Latex Condoms (November 28, 2022)
  • K220489 — Durex Patronus CloseFit, Durex Patronus Regular (November 7, 2022)

FDA data resources