# K980395: Gladrags Cotton Menstrual Pad

- Pathway: 510(k) (Traditional)
- Applicant: Keepers!, Inc.
- Decided: Apr 16, 1998 after 73 days
- Product code: HHD (Pad, Menstrual, Unscented)
- Device class: 1
- Regulation: 21 CFR 884.5435
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
GladRags Cotton Menstrual Pads are washable and reusable. They are meant for personal use (use by only one person) to collect menstrual flow and are designed for external use.

Source page: https://510kreport.com/device/K980395
Methodology: https://510kreport.com/methodology