Cleared Traditional

K052720 - MEDLINE IODOFORM PACKING STRIPS (FDA 510(k) Clearance)

Oct 2005
Decision
21d
Days
Risk

K052720 is an FDA 510(k) clearance for the MEDLINE IODOFORM PACKING STRIPS. This device is classified as a Dressing, Wound, Drug.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on October 20, 2005, 21 days after receiving the submission on September 29, 2005.

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

Submission Details

510(k) Number K052720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2005
Decision Date October 20, 2005
Days to Decision 21 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

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