510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012969Substantially Equivalent

Double Springers Nonoxnol 9 Condom

MedTech Products, Inc., Chennai, IN / Abbreviated, Substantially Equivalent
FDA source (opens on fda.gov)

K012969 is the FDA 510(k) clearance record for DOUBLE SPRINGERS NONOXNOL 9 CONDOM, a class II device, cleared for Medtech Products , Ltd. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 14 510(k) clearances for Medtech Products , Ltd., from to . As of , FDA records show no recalls naming K012969.

Clearance record

Decision date
Received
(281 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Medtech Products , Ltd. S-59 20th St., Anna Nagar W., Chennai, IN
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