# K021546: Dermassist Fluid Resistant Surgical Mask with Wraparound Visor

- Pathway: 510(k) (Traditional)
- Applicant: Creative Contract (M) Sdn Bhd
- Decided: Mar 5, 2003 after 299 days
- Product code: FXX (Mask, 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
DermAssist TM Fluid Resistant Surgical Mask / Procedure Mask with WrapAround Visor is a high filtration 4 ply face mask is intended to be worn by an operating room personnel during surgical procedures to protect both the surgical patients and the operating room personnel from transfer of microorganisms body fluids and particulate materials. The WrapAround Visor is a 3M 0 Anti Fogging Visor, is intended to act as a face shield or an eye shield, during instances where blood and bodily fluids may be splashed upon the surgeon or medical healthcare personnel.

Source page: https://510kreport.com/device/K021546
Methodology: https://510kreport.com/methodology