3M Steri-Drape Chg Antimicrobial Incise Drape

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K140250 ↗

FDA Product Code

KKX

Device Class

Class II

Regulation

21 CFR Part 878.4370

Advisory Committee

General, Plastic Surgery

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the 3M Steri-Drape CHG Antimicrobial Incise Drape in surgical settings?

  The 3M Steri-Drape CHG Antimicrobial Incise Drape is designed to create a sterile barrier over surgical incisions by adhering to the patient’s skin pre-operatively. It incorporates chlorhexidine gluconate (CHG) to help reduce bacterial colonization at the incision site, lowering the risk of surgical site infections.

• Is this drape reusable or intended for single-use, and how is it packaged?

  The drape is explicitly designed for single-use only and comes in sterile packaging, ensuring each application is uncontaminated and ready for immediate surgical use.

• What size is the standard drape, and how does it conform to the patient’s body?

  The standard size is 130 cm x 130 cm (51 in x 51 in), and its transparent adhesive film design allows it to conform closely to the patient’s body contours, providing a secure seal over the incision area.

• How does the antimicrobial feature of this drape differ from standard incise drapes?

  Unlike standard incise drapes, this drape includes chlorhexidine gluconate (CHG), an antimicrobial agent that actively reduces bacterial colonization at the incision site, helping to lower the risk of surgical site infections compared to non-antimicrobial alternatives.

• What regulatory pathway was followed for FDA clearance of this device?

  The 3M Steri-Drape CHG Antimicrobial Incise Drape received FDA 510(k) clearance under product code KKX, following a traditional review process with a decision described as *Substantially Equivalent* to a predicate device. The submission was reviewed by the Orthopaedic and Rehabilitation Devices Panel (HO) of the Surgical, Urological, Gynaecological, Ophthalmic, and Ear, Nose & Throat Devices Advisory Committee (SU).