# K023117: Primagard Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Primeline Medical Products, Inc.
- Decided: Nov 8, 2002 after 58 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.
2 later devices descend from it; 2 cite it directly.
0 of 3 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
- K101593: Emm Surgical Gown-SMS with PE Layer, Model 18-501 L, 18-501-XL, 18-501 XXL, 18-501-XLXL (2010), 0 descendants of its own
- K033057: Deroyal Surgical Gowns, Sterile, Non-Sterile (2003), 0 descendants of its own

## Indications for use
The primaGARD Surgical Drapes are Non-sterile Surgical Gowns, identified in 21 CFR, part 878.4&0, as a medical device intended to be worn by operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from the transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K023117
Methodology: https://510kreport.com/methodology