# K100991: Imc Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Oct 5, 2010 after 179 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 K003755 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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.
- K003755: Medline Blockade or Resistat Surgical Gowns and Surggical Drapes, Medline Industries, Inc. (2001) Summary page 1.

## Indications for use
These devices are intended to be used as protective coverings used to isolate incision sites and protect against contamination during surgical procedures with the additional feature of a finger cot which is latex-free rubber. This submission includes drapes that will be sold both sterile and non-sterile. Non-sterile drapes are to be sold to OEMs for EO sterilization according to ANSIIAMMIIISO 1 13 5. Sterile drapes are to be sold directly to users after EO sterilization validation to ANSIIAMMIIISO 11135 Catalog Number Description 31 -0051 Bladder Suspension Drape 31 -0051 NS Bladder Suspension Drape 61-0091 GYN Procedure Drape 61-0091 NS G YN Procedure Drape 81-0011 TUR Procedure Drape 8i-0011iNS TUR Procedure Drape

Source page: https://510kreport.com/device/K100991
Methodology: https://510kreport.com/methodology