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510(k) K001377

SPERMICIDAL LUBRICATED MALE LATEX CONDOM by Pleasure Latex Products Sdn. Bhd. — Product Code LTZ

K001377 is an FDA 510(k) premarket notification submitted by Pleasure Latex Products Sdn. Bhd. for the device "SPERMICIDAL LUBRICATED MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on June 8, 2000. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Pleasure Latex Products Sdn. Bhd. has at least 9 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 8, 2000
Date Received
May 1, 2000
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Condom With Nonoxynol-9
Device Class
Class II
Regulation Number
884.5310
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)
  • K001221 — MALE LATEX COMDOM WITH DOTTED SURFACE (May 19, 2000)
  • K994312 — MALE LATEX CONDOM 56MM (March 21, 2000)
  • K994311 — MALE LATEX CONDOM WITH VANILLA FLAVOR (March 21, 2000)
  • K982380 — SURE (February 26, 1999)

Other clearances for product code LTZ

  • K033163 — CAUTION CONDOMS (April 27, 2004)
  • K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM (June 12, 2002)
  • K010178 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (April 27, 2001)
  • K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (January 28, 2001)
  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • K992438 — INVIGRA PLUS (WITH SPERMICIDAL LUBRICANT) (August 2, 1999)
  • K991047 — HARDCOVER CONDOMS MALE LATEX CONDOMS, (WITH SPERMICIDE) (June 18, 1999)
  • K990669 — MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9) (May 17, 1999)
  • K981955 — MAXIMA, TRUSTEX, RIA AND PREMIUM EL LES CONDOMS (March 15, 1999)
  • K981621 — ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS (June 19, 1998)

FDA data resources