510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K983320Substantially Equivalent

Royale Brand Latex Condoms Silicone Lubricant Colored-or Assorted Colors

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

K983320 is the FDA 510(k) clearance record for ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS, a class II device, cleared for Suretex Prophylactics (India) , Ltd. on under FDA product code HIS (Condom). FDA records list 3 510(k) clearances for Suretex Prophylactics (India) , Ltd., from to . As of , FDA records show one recall naming K983320.

Clearance record

Decision date
Received
(81 days to decision)
Product code
HIS Condom
Regulation
21 CFR 884.5300
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 HIS

Trailing 12 months
3 clearances under product code HIS in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HIS, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20261
October 20260