# K101689: Emm Equipment Cover-Polythylene

- 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: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K080629 (2008). 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)
- K083234: Kimberly-Clark KC100 Surgical Drapes, Model KC 100, Kimberly-Clark KC100 Surgical Equipment Covers, Model KC 100, Kimberly-Clark Corp. (2009) Summary page 1.

## Recalls of this device
- Apr 29, 2021 · Class II · Z-1907-2021: No 510k for the product to be used in a natural or surgical opening to the body

## Indications for use
Exact Medical Manufacturing Equipment Cover - Polyethylene are sterile single use devices made of natural or synthetic materials intended to be used as a protective equipment covering, such as to isolate equipment from microbial and other contamination. The Exact Medical Manufacturing Equipment Covers-Polyethylene 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/K101689
Methodology: https://510kreport.com/methodology