# K190241: Sterile Latex Surgical Glove, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Careglove Global Sdn. Bhd.
- Decided: Dec 30, 2019 after 327 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K014230 (2002). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014230: Sterile Powder Free Latex Surgeon Gloves with Protein Labeling Claim (50 Microgram or Less), Supermax Glove Manufacturing Sdn Bhd (2002) Summary page 4.

## Indications for use
A sterile latex surgical glove, powder free is a disposable device intended for medical purposes that is worn by operating room personnel to protect a surgical wound from contamination.

Source page: https://510kreport.com/device/K190241
Methodology: https://510kreport.com/methodology