510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K001978Substantially Equivalent

'One Touch' Latex Condom with Nonoxynol-9

Thai Nippon Rubber Industry Co., Ltd., Durham NC / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K001978 is the FDA 510(k) clearance record for 'ONE TOUCH' LATEX CONDOM WITH NONOXYNOL-9, a class II device, cleared for Thai Nippon Rubber Industry Co., Ltd. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 6 510(k) clearances for Thai Nippon Rubber Industry Co., Ltd., from to . As of , FDA records show no recalls naming K001978.

Clearance record

Decision date
Received
(40 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Thai Nippon Rubber Industry Co., Ltd. 1219 Little Creek Rd., Durham NC
510(k) summary
Summary
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