# K101799: Powder Free Latex Examination Gloves Blue (Colored), Non-Sterile, with Protein Labeling Claim of 50UG Per DM2 of Glove

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe (Malaysia) Sdn. Bhd.
- Decided: Sep 3, 2010 after 67 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K121844: Powder Free Natural Rubber Latex Examination Gloves (2013), 0 descendants of its own

## Indications for use
A powder free latex examination glove is a disposable device made of natural rubber material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K101799
Methodology: https://510kreport.com/methodology