# K093179: Medical Surgical Mask (HH1001), Respiratory Mask (HH1002)

- Pathway: 510(k) (Abbreviated)
- Applicant: H&H Research Company
- Decided: Jul 14, 2010 after 279 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
Longest line of descent: 6 generations back to K874608 (1987). 11 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K092580: Tidi Facemask, Tidi Products,Llc (2010). Cleared while this submission was under review Summary page 1.
- K823078: Spunguard Face Mask, Kimberly-Clark Corp. (1983) Summary page 1.
- K063023: 3M Health Care Particulate Respirator and Surgical Mask, Model 1870, 3M Company (2007) Summary page 1.

## Most influential descendants
- K202139: Medical surgical mask (2020), 1 descendant of its own
- K213450: Medical surgical mask (Black mask, Level 1 and Level 3) (2022), 0 descendants of its own
- K202577: Medical Surgical Mask-Model MP002-5, MP002-6 (2021), 0 descendants of its own

## Indications for use
This product is indicated for infection control practices in the health care industry. When worn properly, The New Medical Mask is intended to protect both patient and wearer from the transfer of microorganisms, body fluids and particulate material.

Source page: https://510kreport.com/device/K093179
Methodology: https://510kreport.com/methodology