Cleared Traditional

K033732 - MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 (FDA 510(k) Clearance)

Dec 2004
Decision
369d
Days
Risk

K033732 is an FDA 510(k) clearance for the MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450. This device is classified as a Dressing, Wound, Drug.

Submitted by Medtrade Products , Ltd. (Cheshire, GB). The FDA issued a Cleared decision on December 1, 2004, 369 days after receiving the submission on November 28, 2003.

This device falls under the General & Plastic Surgery FDA review panel.

Submission Details

510(k) Number K033732 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2003
Decision Date December 01, 2004
Days to Decision 369 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FRO — Dressing, Wound, Drug
Device Class

Similar Devices — FRO Dressing, Wound, Drug

All 13
LUOFUCON® Skin and Wound Cleanser (Spray, Mist, Squeeze, Bottle.)
K250642 · Huizhou Foryou Medical Devices Co., Ltd. · Nov 2025
LUOFUCON® Silver Collagen Dressing
K240809 · Huizhou Foryou Medical Devices Co., Ltd. · Dec 2024
LUOFUCON® Silicone Ag+ Foam Dressing (Prescription use)/ LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing (OTC use) (Bordered, Bordered Lite, Non-Bordered, and Transfer)
K242856 · Huizhou Foryou Medical Devices Co., Ltd. · Nov 2024
LUOFUCON® Extra Silver Gelling Fiber Dressing Plus (Prescription use),LUOFUCON® Silver Antimicrobial Gelling Fiber Dressing Plus (OTC use)
K240485 · Huizhou Foryou Medical Devices Co., Ltd. · Oct 2024
LUOFUCON® Silicone Ag+ Foam Dressing, LUOFUCON® Silicone Ag+ Antibacterial Foam Dressing
K223360 · Huizhou Foryou Medical Devices Co., Ltd. · Mar 2024
PluroGel® Antimicrobial Burn and Wound Dressing, PluroGel® Burn and Wound Dressing (OTC)
K233151 · Medline Industries, LP · Mar 2024