ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS— 510(k) K983320

Name: FDA 510(k) clearance K983320
Creator: U.S. Food and Drug Administration
Published: 1998-12-11

Substantially Equivalent

Suretex Prophylactics (India) , Ltd.

FDA 510(k) clearance K983320 for ROYALE BRAND LATEX CONDOMS SILICONE LUBRICANT COLORED-OR ASSORTED COLORS, Substantially Equivalent on 1998-12-11. Applicant: Suretex Prophylactics (India) , Ltd.. Device class: 2.

Clearance details

Applicant: Suretex Prophylactics (India) , Ltd.
Product code: Code HIS
Device class: Class 2
Regulation: 21 CFR 884.5300
Advisory panel: Obstetrics/Gynecology
Date received: 1998-09-21
Decision date: 1998-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bangalore, Karnataka, IN

Download summary PDF View on FDA.gov ↗

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Recalls naming K983320

K-number listed on FDA's recall record

Z-0717-2013 — Lifestyles Pleasure Collection 30 Premium Lubricated Condoms Assortment of Ultra Sensitive, Flavors and Colors, Skyn, Thryll, Thyn, and Ultra Thin. UPC 0-70907-02625-0.Class II·Terminated·Ansell Healthcare Products LLC·20121105

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983320.

Data sourced from openFDA. This site is unofficial and independent of the FDA.