510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K990669Substantially Equivalent

Multiple-Brand Male Latex Condom (Lubricated with Nonoxynol-9)

Dongkuk Techco Rubber Industries Sdn. Bhd., Penang, MY / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K990669 is the FDA 510(k) clearance record for MULTIPLE-BRAND MALE LATEX CONDOM (LUBRICATED WITH NONOXYNOL-9), a class II device, cleared for Dongkuk Techco Rubber Industries Sdn. Bhd. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list one 510(k) clearance for Dongkuk Techco Rubber Industries Sdn. Bhd. As of , FDA records show no recalls naming K990669.

Clearance record

Decision date
Received
(76 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Dongkuk Techco Rubber Industries Sdn. Bhd. 7th Floor Mayban Trust Bldg., Penang, 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