# K971159: Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: International Medsurg Connection
- Decided: Jun 24, 1997 after 85 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Medline Industries, Inc. Sterile OR Towels: named in the summary without a submission number
- (no number) A Plus International Sterile and Non-Sterile OR Towels: named in the summary without a submission number
- (no number) Ulti-Med International Absorbent Fiber Operating Room Towels: named in the summary without a submission number

## Indications for use
For use in hospitals, clinics, laboratories or other facilities where absorbent toweling may be used. For use as absorbent toweling for cleanup, preparation or squaring off a surgical incision site. For use during surgical procedures to provide extra absorption of blood and body fluids. For use a) to dry off surgeons, doctor or nurses hands after scrubbing, (b) to square off a surgical incision site, and (c) to absorb blood or body fluids during a surgical procedure. Not intended for use as surgical packing.

Source page: https://510kreport.com/device/K971159
Methodology: https://510kreport.com/methodology