Home / 510(k) Clearances / K001221

510(k) K001221

MALE LATEX COMDOM WITH DOTTED SURFACE by Pleasure Latex Products Sdn. Bhd. — Product Code HIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 19, 2000
Date Received
April 17, 2000
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 Pleasure Latex Products Sdn. Bhd.

  • K022156 — LATEX ULTRASONIC PROBE COVER (September 11, 2003)
  • K023333 — MULTIPLE, MALE LATEX CONDOM [52MM OR 56MM NOMINAL WIDTH WITH SMOOTH OR DOTTED OR (June 23, 2003)
  • K021875 — MALE LATEX CONDOM WITH DOTTED/RIBBED SURFACE AND COUNOUR-WALLED SHAPE (3 IN 1 UL (September 5, 2002)
  • K020272 — MALE LATEX CONDOM WITH RIBBED SURFACE (April 26, 2002)
  • K002571 — MULITPLE MALE LATX CONDOM (November 16, 2000)
  • K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (June 8, 2000)
  • K994311 — MALE LATEX CONDOM WITH VANILLA FLAVOR (March 21, 2000)
  • K994312 — MALE LATEX CONDOM 56MM (March 21, 2000)
  • K982380 — SURE (February 26, 1999)

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)