# K173258: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy

- Pathway: 510(k) (Traditional)
- Applicant: Pt. Medisafe Technologies
- Decided: Apr 20, 2018 after 192 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 surgeon's glove is a device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. This glove is also tested for use with Chemotherapy Drugs. The Chemotherapy Drugs and its permeation time is listed as below. Test Chemotherapy Drug and Concentration Breakthrough Detection Time (Minutes) Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 37.5 (47.8, 38.3, 37.5) Cisplatin 1.0 mg/ml (1,000ppm) >240 min Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) >240 min Dacarabzine (DTIC) 10.0 mg/ml (10,000 ppm) >240 min Doxorubicin Hydrochloride 2.0 mg/ml (2,000 ppm) >240 min Etoposide (Toposar) 20.0 mg/ml (20,000 ppm) >240 min Fluorouracil 50.0 mg/ml (50,000 ppm) >240 min Ifosfamide 50.0 mg/ml (50,000 ppm) >240 min Methotrexate 25 mg/ml (25, 000 ppm) >240 min Mechlorethamine HCI 1.0 mg/ml (1,000 ppm) >240 min Melphalan 5 mg/ml (5,000 ppm) >240 min Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) >240 min Thiotepa 10.0 mg/ml (10,000 ppm) 58.3 (69.8, 68.6, 58.3) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) >240 min Caution: Testing showed an average breakthrough time for Carmustine (3.3 mg/ml): 37.5 minutes and average breakthrough time of ThioTEPA (10.0 mg/ml): 58.3 minutes

Source page: https://510kreport.com/device/K173258
Methodology: https://510kreport.com/methodology