# K182089: Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Platinum Glove Industries Sdn. Bhd.
- Decided: Jul 30, 2019 after 362 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
A Patient examination glove is a disposable device intended for medical purposes that worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with chemotherapy drugs as listed below. Chemotherapy Drug permeation and concentration (Break through Detection Time) in Minutes. The following chemicals have been tested with these gloves. 1. Carmustine (BCNU)3.3 mg/ml(3,300 ppm) 9.0 min 2. Cisplatin 1.0 mg/ml (l ,000ppm) >240 min 3. Cyclophosphamide (Cytoxan) 20mg/ml (20,000ppm) >240 min 4. Dacarbazine (DTIC)l 0.0 mg/ml (l 0,00Oppm) >240 min 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000ppm) >240 min 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min 7. Fluorouracil 50.0 mg/ml (50,000ppm) >240 min 8. lfosfamide 50.0 mg/ml (50,000ppm) >240 min 9. Methotrexate 25 mg/ml (25,000ppm) >240 min 10. Mitomycin C 0.5 mg/ml (500ppm) >240 min 11. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000ppm) >240 min 13. Thio-Tepa 10.0 mg/ml (10,000ppm) 16.2min 14. Vincristine Sulfate 1.0 mg/ml (1,000ppm) >240min Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes. Do not use with Carmustine and Thio-Tepa

Source page: https://510kreport.com/device/K182089
Methodology: https://510kreport.com/methodology