# K150238: SensiCare Sterile Powder-Free Polymer Coated Polyisoprene Surgical glove, With Aloe Vera (Tested of Use with Chemotherapy Drugs) -Natural Color

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Nov 27, 2015 after 298 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
Longest line of descent: 2 generations back to K013302 (2001). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111139: Derma Prene Isotouch Green Sterile Powder-Free Polyisoprene Surgical Goves, Tested for U, Ansell Healthcare Products, Inc. (2011) Summary page 4.

## Indications for use
The surgeon’s glove is a device made of synthetic rubber latex intended to be worn by surgeons and /or operating room personnel to protect a surgical wound from contamination, and are tested for use with chemotherapy drugs. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes The following chemicals have been tested with these gloves. Carmustine Avg. 15.7 (15.7,16.3,17.0) Cisplatin 240 min. Cyclophosphamide (Cytoxan) 240 min. Dacarbazine (DTIC) 240 min. Doxorubicin Hydrochloride 240 min. Etoposide (Toposar) 240 min. Fluorouracil 240 min. Ifosfamide 240 min. Methotrexate 240 min. Mitomycin C 240 min. Paclitaxel (Taxol) 240 min. Thiotepa Avg. 15.3 min. (15.3,15.3,15.3) Vincristine Sulfate 240 min. WARNING: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K150238
Methodology: https://510kreport.com/methodology