510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K972836Substantially Equivalent

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

G. Premjee (USA), Inc., Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K972836 is the FDA 510(k) clearance record for ROYALE BRAND LATEX CONDOMS-SPERMICIDAL LUBRICANT - COLORED OR ASSORTED COLORS, a class II device, cleared for G. Premjee (Usa), Inc. on under FDA product code LTZ (Condom With Nonoxynol-9). FDA records list 2 510(k) clearances for G. Premjee (Usa), Inc., from to . As of , FDA records show no recalls naming K972836.

Clearance record

Decision date
Received
(83 days to decision)
Product code
LTZ Condom With Nonoxynol-9
Regulation
21 CFR 884.5310
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
G. Premjee (Usa), Inc. 55 Norther Blvd. Suite 410, Great Neck NY
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