# K093375: KS-Care Powder Free Polymer Coated Latex Examination Glove with Protein Content Labeling Claim (50UG or Less)

- Pathway: 510(k) (Traditional)
- Applicant: Koon Seng Sdn Bhd
- Decided: Dec 2, 2009 after 34 days
- Product code: LYY (Latex Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011377 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071060: Non-Sterile, Latex Powder Free Patient Examination Gloves (Multicolored with Xylitol and Calcium Carbonate), Sgmp Co., Ltd. (2007) Summary page 2.
- K081488: Powder Free Latex Examination Gloves, Non-Sterile, Pt. Maja Agung Latexindo (2008) Summary page 2.

## Indications for use
A powder free patient examination glove is a disposable device intended for medical purposes that is worn on the examiners hand or finger to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K093375
Methodology: https://510kreport.com/methodology