510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K971132Substantially Equivalent

Royale Brand Latex Condoms (Silicone)-Colored/assorted Colors

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

K971132 is the FDA 510(k) clearance record for ROYALE BRAND LATEX CONDOMS (SILICONE)-COLORED/ASSORTED COLORS, a class II device, cleared for G. Premjee (Usa), Inc. on under FDA product code HIS (Condom). FDA records list 2 510(k) clearances for G. Premjee (Usa), Inc., from to . As of , FDA records show one recall naming K971132.

Clearance record

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