# K050598: Powder Free Nitrile Examination Glove with Tested for Use with Chemotherapy Drugs Labeling Claim (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corp. Sdn Bhd
- Decided: Apr 7, 2005 after 29 days
- Product code: LZA (Polymer 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.
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
Powder Free Nitrile Examination Gloves Tested for Use With Chemotherapy Drugs (Blue) is a disposable device intended for Medical Purposes that is worn on the examiner's hand to prevent contamination between patient and examinar. This device also provides protection against exposure to certain chemotherapy drugs.

Source page: https://510kreport.com/device/K050598
Methodology: https://510kreport.com/methodology