# K911334: Mask, Surgical Apparel

- Pathway: 510(k) (Traditional)
- Applicant: Thai Hospital Products Co., Ltd.
- Decided: Aug 29, 1991 after 156 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.
15 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K200847: Surgical Face Mask (2020), 14 descendants of its own
- K211105: Ear-Friendly Mask (2021), 2 descendants of its own
- K212398: Surgical Face Mask (Non-sterile) (2021), 1 descendant of its own
- K202615: Nordiwell Medical Face Mask (2020), 1 descendant of its own
- K221682: Ideal Med Pro 3-Ply Disposable Face Mask (2023), 0 descendants of its own

Source page: https://510kreport.com/device/K911334
Methodology: https://510kreport.com/methodology