# K022868: Primagard Surgical Equipment Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Primeline Medical Products, Inc.
- Decided: Nov 8, 2002 after 71 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K041501: Guangzhou Fortunique Drapes, Bags and Covers (2004), 0 descendants of its own

## Indications for use
The pnmaGARD Surgical Equipment Covers are Non-stenk surgical equipment covers, identified i n 21 CFK, part 878.4330 The drapes are made of natural and/or synthetic material and used as a protectme equipment covenng. The primary purpose of this d r a p is to isolate equipment from contaminaling the sterile field during surgery. This IS to maintain the sterile technique in an operating room.

Source page: https://510kreport.com/device/K022868
Methodology: https://510kreport.com/methodology