# K970891: Drape, Surgical-Latex

- Pathway: 510(k) (Traditional)
- Applicant: Protek Medical Products, Inc.
- Decided: Aug 22, 1997 after 164 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 K844472 (1985). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K895614: Civco Latex Ultrasound Sheaths, CIVCO Medical Instruments Co., Inc. (1989) Summary page 4.
- K844472: Civco Scan Drape, CIVCO Medical Instruments Co., Inc. (1985) Summary page 4.
- K943393: Civco Probe Boot/Cord Cover, CIVCO Medical Instruments Co., Inc. (1995) Summary page 4.
- K882724: Microtek Probe Drape, Microbio-Medics, Inc. (1988) Summary page 4.
- (no number) Amedic of Sweden device: named in the summary without a submission number

## Indications for use
Latex Drapes for Ultrasound Transducers. A surgical drape and drape accessories used as a protective covering between an instrument and the patient to isolate a site of surgical incision from microbial and other contaminants

Source page: https://510kreport.com/device/K970891
Methodology: https://510kreport.com/methodology