# K080827: Handan N95 Particulate Respirators and Surgical Mask, Models HY8510 and HY9810

- Pathway: 510(k) (Abbreviated)
- Applicant: Handan Hengyong Protective & Clean Products Co., L
- Decided: Apr 4, 2008 after 10 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). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 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.

## Indications for use
The Handan N95 Particulate Respirators and Surgical Masks HY8510, HY9810 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 and body fluids, and airborne particulate materials. This includes use as a procedure mask, isolation mask or dental face mask. This device also meets CDC Guidelines for TB Exposure Control.

Source page: https://510kreport.com/device/K080827
Methodology: https://510kreport.com/methodology