# K091147: Powder Free Nitrile Examination Glove (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corp. Sdn Bhd
- Decided: Jul 27, 2009 after 98 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
This glove is a disposable device intended for medical purposes that is worn on the examiner's hand to prevent contamination between patient and examiner. This glove has been tested for use with specific chemotherapy drugs listed below. Chemotherapy Drug — Permeation (Average Breakthrough Detection Time in Minutes) Dacarbazine (DTIC) — >240 Cyclophosphamide (Cytoxan) — 69.59 Doxorubicin Hydrochloride — >240 5-Fluorouracil — >240 Cisplatin — >240 Etoposide — >240 Paclitaxel (taxol) — >240 Warning: Do Not Use With Thiotepa or Carmustine

Source page: https://510kreport.com/device/K091147
Methodology: https://510kreport.com/methodology