# K090131: DS N95 Surgical Masks and Flat Surgical

- Pathway: 510(k) (Abbreviated)
- Applicant: Shanghai Dasheng Health Products
- Decided: Apr 27, 2009 after 96 days
- Product code: MSH (Respirator, 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: 3 generations back to K922507 (1992). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K041855: Pleats Plus N95 Particulate Respirator, Models 1050 and 1050S, Aearo Co. (2004) Summary page 2.
- K960778: Isolair Apr Type N95, Louis M. Gerson Co., Inc. (1996) Summary page 2.
- K022256: Surgical Face Mask - Colors: White, Yellow, Pink, Blue, and Green, Tucker & Associates (2004) Summary page 2.

## Indications for use
The DS N95 Surgical Masks DTC3M-1/DTC3B, and flat surgical masks are intended for single use by operating room personnel and other health care workers to protect both the patients and the health care workers from transfer of microorganisms, blood fnd body fluids, and airborne particulate materials.

Source page: https://510kreport.com/device/K090131
Methodology: https://510kreport.com/methodology