# K102652: Non Reinforced Surgical Gowns, Film Reinforced Surgical Gowns, Fabric Reinforced Surgical Gowns

- Pathway: 510(k) (Traditional)
- Applicant: Gri Medical & Electronic Technology Co., Ltd.
- Decided: Feb 3, 2011 after 142 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: 2 generations back to K091097 (2009). 4 ancestors in all.
8 later devices descend from it; 2 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K093115: Kimberly-Clark KC100 Surgical Gown, Model KC100, Kimberly-Clark Corp. (2010) Summary page 2.
- K061308: Trimax, Model 9515N, Breathable Surgical Gown, Models 3247AN and 9015N and Optima or Surgical Gown, Model 9506N, Cardinal Health 200, Inc. (2006) Summary page 2.
- K080795: Ultra Surgical Gown & Fluid Barrier Surgical Gown, Kimberly-Clark Corp. (2008) Summary page 2.

## Most influential descendants
- K121152: Surgical Gown, SMS (2012), 7 descendants of its own
- K212869: Disposable Surgical Gown, Disposable Reinforced Surgical Gown (2021), 3 descendants of its own
- K141467: Surgical Gown (2015), 1 descendant of its own
- K253003: Non-sterile Level 3 Surgical Gown (4025); Sterile Level 3 Surgical Gown (M4025); Non-sterile Reinforced Level 4 Surgical Gown (G4025); Reinforced Sterile Level 4 Surgical Gown (GM4025) (2026), 0 descendants of its own
- K222456: High Protection Surgical Gown (2023), 0 descendants of its own

## Indications for use
GRI's Non Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Non Reinforced Surgical Gowns meet Level 2 of the SAAMI Liquid Barrier classifications. See Page 4-2 for product list. GRI's Film Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the SAAMI Liquid Barrier classifications. See Page 4-2 for product list. GRI's Fabric Reinforced Surgical Gowns are sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-2 for product list. GRI's Non Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Non Reinforced Surgical Gowns meet Level 2 of the MAMI Liquid Barrier classifications. See Page 4-4 for product list. GRI's Film Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Film Reinforced Surgical Gowns meet Level 3 of the AAMI Liquid Barrier classifications. See Page 4-4 for product list. GRI's Fabric Reinforced Surgical Gowns are non-sterile, single use surgical gowns intended to protect surgical patients and operating room personnel from the transfer of microorganisms, body fluids, and particulate material. GRI's Fabric Reinforced Surgical Gowns meet Level 3 of the MAMI Liquid Barrier classifications. See Page 4-4 for product list.

Source page: https://510kreport.com/device/K102652
Methodology: https://510kreport.com/methodology