# K211536: Welspun Health Surgical Mask

- Pathway: 510(k) (Traditional)
- Applicant: Welspun India Limited
- Decided: Sep 1, 2021 after 106 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: 10 generations back to K874608 (1987). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202511: Disposable Medical Surgical Mask, Improve Medical (Hunan) Co., Ltd. (2021) Summary page 5.

## Indications for use
The Welspun Health Surgical Mask is intended to be worn to protect both the patient and healthcare personnel from transfer of microorganisms, body fluids and particulate material. The surgical face masks are intended for use in infection control practices to reduce the potential exposure to blood & body fluid. This device is disposable, non-sterile and for single use only.

Source page: https://510kreport.com/device/K211536
Methodology: https://510kreport.com/methodology