510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001377Substantially Equivalent

Spermicidal Lubricated Male Latex Condom

Pleasure Latex Products Sdn. Bhd., Jeram, Selangor Darul Ehsan, MY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K001377 is the FDA 510(k) clearance record for SPERMICIDAL LUBRICATED MALE LATEX CONDOM, a class II device, cleared for Pleasure Latex Products Sdn. Bhd. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 10 510(k) clearances for Pleasure Latex Products Sdn. Bhd., from to . As of , FDA records show no recalls naming K001377.

Clearance record

Decision date
Received
(38 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pleasure Latex Products Sdn. Bhd. Lot 1365, 17th Miles, Jalan, Jeram, Selangor Darul Ehsan, MY
510(k) summary
Statement
Third party review
No

Clearances, product code LTZ

Trailing 12 months

FDA records hold no clearances under product code LTZ in the trailing twelve months.

FDA records show no clearances under product code LTZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LTZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260