# K101468: 3M Basic Disposable Surgical Gown, 3M HP Disposable Surgical Gown, 3M Reinforced Disposable Surgical Gown, 3M Disposable

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company Corp
- Decided: Apr 14, 2011 after 322 days
- Product code: FYA (Gown, 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 K080795 (2008). 1 ancestor in all.
1 later device descends from it; 1 cites 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)
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown, Kimberly-Clark Corp. (2008) Summary page 1.

## Most influential descendants
- K261811: PRIMED Chemotherapy Drug Tested Gowns (PM4-99450: PRIMED Chemotherapy Drug Tested Isolation Gown, Purple, AAMI Level 2; PM4-99460: PRIMED Chemotherapy Drug Tested Isolation Gown, Blue, AAMI Level 3) (2026), 0 descendants of its own

## Indications for use
The 3Mtm Basic Disposable Surgical Gowns, 3M~m Disposable Surgical Gowns and 3Mtm HP Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. These gowns meet level 2 of the AAMI Liquid Barrier Classification. The 3MTm Reinforced Disposable Surgical Gowns and 3Mtm HP Reinforced Disposable Surgical Gowns are items of surgical apparel intended to be worn by health care professionals to help protect both the patient and health care worker from transfer of microorganisms, body fluids and particulate matter. The extra reinforced material is non-permeable and therefore provides a 100% barrier to liquids and blood- These gowns meet level 4 of the AAMI Liquid Barrier Classification within the critical areas of the gowns.* *To fulfill these requirements, extra reinforced material sheets are integrated into parts of the gown on the front panel and in both sleeves from the cuff to the elbow. These gowns are for single use.

Source page: https://510kreport.com/device/K101468
Methodology: https://510kreport.com/methodology