# K181047: Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested  for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corporation Sdn. Bhd.
- Decided: Jan 9, 2019 after 265 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
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 (Breakthrough Detection Time) in Minutes. The following chemicals have been tested with these gloves. Breakthrough Detection Time in Minutes Chemotherapy Drugs: White Glove Blue Glove 1. Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 79.0 min 48.5 min 2. Cisplatin 1.0 mg/ml (1,000 ppm) >240 min >240 min 3. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min >240 min 4. Dacarbazine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min >240 min 5. Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min >240 min 6. Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min >240 min 7. Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min >240 min 8. Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min >240 min 9. Methotrexate 25 mg/ml (25,000 ppm) >240 min >240 min 10. Mitomycin C 0.5 mg/ml (500 ppm) >240 min >240 min 11. Mitoxantrone 2.0 mg/ml (2,000 ppm) >240 min >240 min 12. Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min >240 min 13. Thio-Tepa 10.0 mg/ml (10,000 ppm) 79.2 min 169.4 min 14. Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min >240 min Please Note that Carmustine and Thio-Tepa have low permeation time of less than 240 minutes

Source page: https://510kreport.com/device/K181047
Methodology: https://510kreport.com/methodology