# K160361: PRIMAGARD Isolation Gown (AAMI PB70 Level 3)

- Pathway: 510(k) (Traditional)
- Applicant: Primed Medical Products, Inc.
- Decided: Nov 4, 2016 after 269 days
- Product code: FYC (Gown, Isolation, 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
Longest line of descent: 1 generation back to K981393 (1998). 1 ancestor in all.
2 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K981393: Microcool Surgical Gown, Kimberly-Clark Corp. (1998) Summary page 4.

## Most influential descendants
- K232849: Halyard Tri-Layer AAMI 3 Isolation Gown, L, Blue (54310), Halyard Tri-Layer AAMI 3 Isolation Gown, X-Large, Blue (54311) (2024), 0 descendants of its own
- K212717: Paneffort AAMI Level 3 Isolation Gown (2022), 0 descendants of its own

## Indications for use
PRIMAGARD Level 3 Isolation Gowns, are intended to be worn by healthcare personnel in isolation applications to provide moderate barrier protection for healthcare personnel and patients from transfer of microorganisms, body fluids, and particulate material. The PRIMAGARD Isolation Gowns, meet the requirements of level 3 Liquid Barrier Performance as per AAMI PB70:2012 and are provided non-sterile and are single use only. PRIMAGARD Isolation Gowns (AAMI PB70 level 3) are available in 5 models as below: - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tape Tab Neck Closure (Universal, XL), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Hook and Loop Closure (Universal, XL), - PRIMAGARD Overhead Isolation Gown, AAMI PB70 Level 3, Apron Neck Closure (Universal, XL), - PRIMAGARD Isolation Gown, AAMI PB70 Level 3, Tie Neck Closure (Universal, XL)

Source page: https://510kreport.com/device/K160361
Methodology: https://510kreport.com/methodology