# K970286: Presbyterian Linen Services Surgical Packs

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 10, 1997 after 45 days
- Product code: LRO (General Surgery Tray)
- 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 K930700 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932522: Amsco Sterile Recoveries Surgical Packs, Amsco Sterile Recoveries, Inc. (1994) Summary page 1.
- K935199: Surgical Apparel, Associated Hospital Services, Inc. (1994) Summary page 1.
- K930700: Medlines Repeat Performance Surgical Pack System, Medline Industries, Inc. (1993) Summary page 1.

## Indications for use
Presbyterian Linen Services Surgical Packs are intended to be used in various surgical procedures. The packs provide sterile gowns, drapes and towels to be used during procedures to protect both the surgical patient and the operating room personnel from transfer of microbial and other contamination. Surgical towels provide additional absorption of blood and body fluids when used to square off a surgical site, or may be used by operating room personnel for drying of hands after scrubbing.

Source page: https://510kreport.com/device/K970286
Methodology: https://510kreport.com/methodology