# K150973: NUZONE X2G Polychloroprene Synthetic Green Surgical Gloves Powder Free, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Terang Nusa Snd Bhd
- Decided: Aug 4, 2015 after 113 days
- Product code: KGO (Surgeon'S Gloves)
- Device class: 1
- Regulation: 21 CFR 878.4460
- 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 Surgeons glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves are tested for use with Chemotherapy Drugs. Testing based on ASTM D6978-05 DRUG — Minimum Breakthrough Detection Time (Specimen 1/2/3), Minutes Carmustine (BCNU), 3.3 mg/ml (3,300ppm) — 30.6 (30.6, 30.6, 30.8) Cisplatin, 1.0 mg/ml (1,000ppm) — Up to 240 Cyclophosphamide (Cytoxan), 20 mg/ml (20,000ppm) — Up to 240 Dacarbazine (DTIC), 10.0 mg/ml (10,000ppm) — Up to 240 Doxorubicin Hydrochloride, 2.0 mg/ml (2,000ppm) — Up to 240 Etoposide (Toposar), 20.0 mg/ml (20,000ppm) — Up to 240 Paclitaxel (Taxol), 6.0 mg/ml (6,000ppm) — Up to 240 Fluorouracil, 50.0 mg/ml (50,000ppm) — Up to 240 Thiotepa, 10.0 mg/ml (10,000ppm) — 31.2 (31.2, 60.8, 61.3) Vincristine Sulfate, 1.0 mg/ml (1,000ppm) — Up to 240 Please note that the following drugs have low permeation times: Carmustine (BCNU) 30.6 Thiotepa 31.2

Source page: https://510kreport.com/device/K150973
Methodology: https://510kreport.com/methodology