# K101688: Emm Surgical Drape-Spunlace W/PE Sides, Model 13-004

- Pathway: 510(k) (Traditional)
- Applicant: Exact Medical Manufacturing, Inc.
- Decided: Sep 20, 2010 after 96 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 K964142 (1997). 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)
- K964142: Medline Disposable Surgical Drapes and Gowns, Medline Industries, Inc. (1997) Summary page 1.

## Indications for use
Exact Medical Manufacturing Surgical Surgical Drape - Spunlace w/PE Sides are sterile or non-sterile single use devices made of natural or synthetic materials intended to be used as a protective patient covering, such as to isolate a site of surgical incision from microbial and other contamination. The Exact Medical Manufacturing Surgical Drape - Spunlace w/PE Sides are also sold as bulk non-sterile, single use items, to repackager/relabeler establishments for further packaging and ethylene oxide sterilization

Source page: https://510kreport.com/device/K101688
Methodology: https://510kreport.com/methodology