# K981073: Medcom Gown Pack, Medcom Drape Pack & Medcom Towel Pack

- Pathway: 510(k) (Traditional)
- Applicant: Medcom Laundry Service, Inc.
- Decided: May 15, 1998 after 52 days
- Product code: FYA (Gown, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
To be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room peronnel from the transfer of microorganisms, body fiuids, and particulate material. Return to Medcom Laundry Services after use for reprocessing / recycling. To be used as a protective patient covering, such as to isolate the site of surgical incision from microbial and other contamination. Return to Medcom Laundry Services after use for reprocessing / recycling. To be used as an accessory to other surgical drapes; wiping, blotting, hand drying, etc. Return to Medcom Laundry Services after use for reprocessing / recycling.

Source page: https://510kreport.com/device/K981073
Methodology: https://510kreport.com/methodology