# K093500: Powder Free Nitrile Examination Gloves, White (Non-Colored) or Blue (Colored), Non-Sterile

- Pathway: 510(k) (Traditional)
- Applicant: Wear Safe (Malaysia) Sdn. Bhd.
- Decided: Jan 19, 2010 after 68 days
- Product code: LZC (Medical Glove, Specialty)
- 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.
11 later devices descend from it; 1 cites it directly.
0 of 12 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
- K123469: Powder Free Nitrile Patient Examination Glove, Blue and White Colored, Non-Sterile (2013), 10 descendants of its own
- K142862: POWDER FREE NITRILE EXAMINATION GLOVE, BLUE (Colored). (2015), 8 descendants of its own
- K172015: Powder Free Nitrile Examination Gloves, Blue (Colored) (2017), 5 descendants of its own
- K220442: Synguard Nitrile Exam Glove (2022), 2 descendants of its own
- K201857: Powder Free Nitrile Examination Glove Black and Dual Color White-Blue (2021), 1 descendant of its own

## Indications for use
A powder free nitrile examination glove is a disposable device made of synthetic material intended to be worn on the hand for medical purposes to provide barrier against potentially infectious materials and other contaminants. In addition, this product is tested for use with chemotherapy drugs.

Source page: https://510kreport.com/device/K093500
Methodology: https://510kreport.com/methodology