# K102623: Blue Powderfree Nitrile Examination Glove

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Jun 6, 2011 after 266 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. The FDA summary names no predicate by number.

## Indications for use
Powder-Free Blue Nitrile Examination Glove is a disposable device intended for medical purposes that is worn on the examiner's hand or fingers to prevent contamination between Examiner and Patient. Tested for use with Chemotherapy Drugs as listed below. Chemotherapy Drug Permeation (Breakthrough Detection rime) in Minutes. The following chemicals have been tested with these gloves 1 Carmustine 1.04 2 Cisplatin >240 3 Cyclophosphamide >240 4 Dacarbazine >240 5 Doxorubicin Hydrochloride >240 6 Etoposide >240 7 Flourouracil >240 8 Paclitaxel >240 9 Thiotepa =165 Please note that Carmustine has an extremely low Permeation time of less than 30 minutes.

Source page: https://510kreport.com/device/K102623
Methodology: https://510kreport.com/methodology