# K043015: 3L Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: 3l Medical Products Co., Ltd.
- Decided: Aug 15, 2005 after 286 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031287 (2003). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031287: Steri-Drape Surgical Drapes, 3M Company (2003) Summary page 1.

## Indications for use
3L® Surgical Drapes described in this submission are intended to be used to provide an isolating barrier during surgical procedures. The drapes cover the patient and are made of plastic with a protective film that stops fluid strike-through. The drapes submitted provide an isolator as a vertical barrier to keep the C-arm from the surgical field during hip/femur fracture or trauma procedures, or create a isolating barrier during orthopedic procedures, or provide secure adhesion on drapes for general use, or meet surgical minor procedural needs, or give a sterile surface all of the way to the wound.

Source page: https://510kreport.com/device/K043015
Methodology: https://510kreport.com/methodology