# K190306: AMD Ritmed AssureWear VersaGown

- Pathway: 510(k) (Traditional)
- Applicant: Amd Medicom, Inc.
- Decided: Jan 17, 2020 after 339 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: 2 generations back to K952116 (1995). 2 ancestors in all.
6 later devices descend from it; 5 cite it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160339: Cardinal Health Isolation Gown, Cardinal Health200, LLC (2016) Summary page 4.

## Most influential descendants
- K203415: Surgical Isolation Gown (2021), 1 descendant of its own
- K230135: Copioumed Chemotherapy Isolation Gown (2023), 0 descendants of its own
- K210414: CoverU Disposable Gown with Tape AAMI Level 4 Isolation Gown CoverU Disposable Gown with Tape - Chemo Gown (2022), 0 descendants of its own
- K214116: AAMI4 Isolation Gown (2022), 0 descendants of its own
- K212422: Disposable Surgical Isolation Gown (2022), 0 descendants of its own

## Indications for use
AMD Ritmed AssureWear™ VersaGown is intended to be worn by healthcare personnel to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. AssureWear™ VersaGown meets the requirements of an AAMI Level 3 barrier protection for an isolation gown per ANSI/AAMI PB70:2012 Liquid Barrier Performance Classification of Protective Apparel Drapes Intended for Use in Health Care Facilities (ANSI/AAMI PB70). AMD Ritmed AssureWear™ VersaGown is a single use, non-sterile disposable medical device and not intended for use in operating rooms. The medical device will be available in 18 models in large and X-large sizes. Flexneck Models Flexneck Plus Models Tie Models A69964 A69933 A8300 A69965 A69934 A8301 A69966 A69935 A8302 A69967 A69936 A8303 A69968 A69937 A8304 A69969 A69938 A8305

Source page: https://510kreport.com/device/K190306
Methodology: https://510kreport.com/methodology