# K083410: Powder Free Latex Patient Examination Gloves, Tested for Use with Chemotherapy Drugs with a Protein Content Label Claim

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jul 31, 2009 after 255 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
Longest line of descent: 1 generation back to K972616 (1999). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972616: Oncology Plus Powder Free Latex Examination Gloves (Protein Content Labeling), Wembley Rubber Products (M) Sdn Bhd (1999) Summary page 1.

## Indications for use
The powder free chemotherapy examination glove is a specialty medical glove which is a disposable device intended for medical purposes that is worn on the examiner's hand or forefinger to prevent contamination between examiner and patient bodily fluids, waste or environment. Tested for use with chemotherapy drugs. Tested chemotherapy drugs are as follows [Cyclophosphamide, Carmustine, Thio-Tepa, Dacarbazine, Doxorubicin Hydrochloride; 5- Fluorouracil, Cisplatin, Etoposide, and Paclitaxel] WARNING: DO NOT USE GLOVES WITH THIO-TEPA AND CARMUSTINE

Source page: https://510kreport.com/device/K083410
Methodology: https://510kreport.com/methodology