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510(k) K010178

SPERMICIDAL LUBRICATED MALE LATEX CONDOM by Innolatex Sdn. Bhd — Product Code LTZ

K010178 is an FDA 510(k) premarket notification submitted by Innolatex Sdn. Bhd for the device "SPERMICIDAL LUBRICATED MALE LATEX CONDOM". The FDA issued a decision of Substantially Equivalent on April 27, 2001. The device falls under product code LTZ (Condom With Nonoxynol-9), a Class II device regulated under 21 CFR 884.5310. Innolatex Sdn. Bhd has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2001
Date Received
January 19, 2001
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 Innolatex Sdn. Bhd

  • K053367 — MALE NATURAL RUBBER LATEX CONDOM (February 21, 2006)
  • K041837 — INNOLATEX MALE LATEX CONDOMS COLORED AND SCENTED (September 24, 2004)
  • K012962 — DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K012665 — ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT (November 9, 2001)
  • K012664 — ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT (November 9, 2001)
  • K012964 — 56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM (November 9, 2001)
  • K010919 — MALE NATURAL RUBBER LATEX CONDOM (June 15, 2001)
  • K002393 — NON-SPERMICIDAL LUBRICATED MALE LATEX CONDOM (December 19, 2000)

Other clearances for product code LTZ

  • K033163 — CAUTION CONDOMS (April 27, 2004)
  • K012969 — DOUBLE SPRINGERS NONOXNOL 9 CONDOM (June 12, 2002)
  • K003375 — CONTROL MALE CONDOMS OF NATURAL RUBBER LATEX (January 28, 2001)
  • K001978 — 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9 (August 8, 2000)
  • K001377 — SPERMICIDAL LUBRICATED MALE LATEX CONDOM (June 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