# K021220: Nitrile Patient Examination Glove Powder-Free (Blue Color) Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Siam Sempermed Corp., Ltd.
- Decided: Jun 6, 2002 after 76 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
A Patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hands or finger to prevent contamination between patient and examiner. (21CFR 880.6250) Gloves to be used for protection against chemotherapy drug exposure during use with chemotherapy drug preparation and administration to patients. Chemotherapy drugs tested are: Amethopterin Hydrate, Cisplatin, Cyclophosphamide, Dacarbazine, Doxorubincin Hydrochloride, Etoposide, 5-Flourouracil, Paclitaxel, and Vincristine Sulfate.

Source page: https://510kreport.com/device/K021220
Methodology: https://510kreport.com/methodology