# K160337: Safecare Open Back Protective Gowns and ValueCare Open Back Protective Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Bam Corporation Limited
- Decided: Jul 7, 2017 after 515 days
- Product code: QPC (Gown, Non-Sterile, Non-Isolation, Intended To Provide Moderate Or High Barrier Protection)
- 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 K925077 (1993). 1 ancestor in all.
5 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K925077: Poly-Med Disp. Pers. Prot. Gown Apron & Shoecovers, Medtek Development Corp. (1993) Summary page 6.

## Most influential descendants
- K210405: ProTEC-USA EZDoff Gown (2021), 2 descendants of its own
- K233526: Medline Open-back Level 3 Protective Gown (2024), 1 descendant of its own
- K262007: PRIMED AAMI Level 3 Open Back Gowns (2026), 0 descendants of its own
- K203821: Donagamex Blue Performance Protective Gown (2021), 0 descendants of its own
- K211538: Protect X Level 3 Isolation Gown (2021), 0 descendants of its own

## Indications for use
These gowns are intended to protect health care patients and health care personnel from the transfer of microorganisms, body fluids and particulate material. The back of the gown is open and non-protective. They are not intended for use in the operating room.

Source page: https://510kreport.com/device/K160337
Methodology: https://510kreport.com/methodology