510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981621Substantially Equivalent

Royale of Latex Condoms - Spermicidal Lubricant - Colored or Assorted Colors

Suretex Prophylactics (India), Ltd., Bangalore, Karnataka, IN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981621 is the FDA 510(k) clearance record for ROYALE OF LATEX CONDOMS - SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS, a class II device, cleared for Suretex Prophylactics (India) , Ltd. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 3 510(k) clearances for Suretex Prophylactics (India) , Ltd., from to . As of , FDA records show one recall naming K981621.

Clearance record

Decision date
Received
(44 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Suretex Prophylactics (India) , Ltd. 74-91 Kiadb Industrial Estate, Bangalore, Karnataka, IN
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