# K180221: Powder Free White, Green Sterilized Polychloroprene Copolymer Surgical  Gloves - Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Smart Glove Corporation Sdn. Bhd.
- Decided: Aug 8, 2018 after 195 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 Green Glove I. Carmustine ( BCNU)3.3 mg/ml(3,300 ppm) 108.3 min 88.2 min 2. Cisplatin 1.0 mg/ml (1,000ppm) >240 min >240 min 3. Cyclophosphamide (Cytoxan) 20mg/ml(20.000ppm) >240 min >240 min 4. Dacarbazine (DTIC)10.0 mg/ml( 10,000ppm) >240 min >240 min 5. Doxorubicin Hydrochloride 2.0 mg/ml (2.000ppm) >240 min >240 min 6. Etoposide (Toposar) 20.0 mg/ml (20,000ppm) >240 min >240 min 7. Fluorouracil 50.0 mg/ml (50.000ppm) >240 min >240 min 8. Ifostamide 50.0 mg/ml (50,000ppm) >240 min >240 min 9. Methotrexate 25 mg/ml (25,000ppm) >240 min >240 min 10.Mitomycin C 0.5 mg/ml (500ppm) >240 min >240 min I'. Mitoxantrone 2.0 mg/ml (2,000ppm) >240 min >240 min 12. Paclitaxel (Taxol) 6.0 mg/ml (6.000ppm) >240 min >240 min I3. Thio-Tepa 10.0 mg/ml (10.000ppm) 118.7 min 99.4 min 14.Vincristine Sulfate 1.0 mg/ml (1.000ppm) >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/K180221
Methodology: https://510kreport.com/methodology