Home / 510(k) Clearances / K884402

510(k) K884402

EXTRA STRENGTH SKIN LESS SKIN CONDOM by Okamoto USA, Inc. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1989
Date Received
October 19, 1988
Clearance Type
Traditional
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 Okamoto USA, Inc.

  • K243584 — 0.04 ZERO ZERO FOUR Male Latex Condom (February 18, 2025)
  • K203541 — Okamoto 002 Lubricated Polyurethane Male Condom (February 25, 2022)
  • K192669 — Extremely Thin 003, ZERO ZERO THREE (July 24, 2020)
  • K141256 — OKAMOTO STUDDED CONDOM (July 23, 2014)
  • K140379 — MEGA BIG BOY CONDOM (July 1, 2014)
  • K090259 — OKAMOTO ULTRA THIN (March 31, 2009)
  • K952393 — OKAMOTO CONDOM (August 9, 1995)
  • K902804 — EXTEND STABILITY DATE FOR CONDOM W/SPERM LUBRICANT (August 13, 1990)
  • K896339 — MODIFIED LABELING ON OKAMOTO HARMONY CONDOM (January 10, 1990)
  • K884401 — SKIN LESS SKIN CONDOM W/SPERMICIDAL LUBRICANT (January 12, 1989)

Other clearances for product code HIS

  • 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)
  • K222068 — Durex Penck III Regular (October 12, 2022)