# K823078: Spunguard Face Mask

- Pathway: 510(k) (Traditional)
- Applicant: Kimberly-Clark Corp.
- Decided: Jan 7, 1983 after 80 days
- Product code: FXX (Mask, Surgical)
- Device class: 2
- Regulation: 21 CFR 878.4040
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 1 cites it directly.
0 of 5 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
- K093179: Medical Surgical Mask (HH1001), Respiratory Mask (HH1002) (2010), 3 descendants of its own
- 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

## Recalls of this device
- Nov 8, 2024 · Class II · Z-0729-2025: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is p
- Nov 8, 2024 · Class II · Z-0728-2025: Not meeting the bioburden testing requirements of EN 14683 required for masks sold in Europe. Face masks sold in the United States are not required to meet this standard. However, if the standard is p

Source page: https://510kreport.com/device/K823078
Methodology: https://510kreport.com/methodology