# K191915: SensiCare Sterile Power-Free Polymer Coated Polyisoprene Sugical Glove, Coated with Aloe V

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 6, 2020 after 233 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 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 Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 22.5 (23.4, 23.8, 22.5) minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes Dacarbazine (DTIC) 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5 mg/ml >240 minutes Methotrexate 25 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10 mg/ml >240 minutes Rituximab 10 mg/ml >240 minutes Thiotepa 10.0 mg/ml 24.4 (25.3, 24.4, 25.6) minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Warning: Do not use with Carmustine and Thiotepa 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 Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carmustine (BCNU) 3.3 mg/ml 13.7 (14.4, 14.4, 13.7) minutes Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes Dacarbazine (DTIC) 10.0 mg/ml >240 minutes Doxorubicin Hydrochloride 2.0 mg/ml >240 minutes Epirubicin (Ellence) 2 mg/ml >240 minutes Etoposide (Toposar) 20.0 mg/ml >240 minutes Fludarabine 25.0 mg/ml >240 minutes Fluorouracil 50.0 mg/ml >240 minutes Idarubicin 1.0 mg/ml >240 minutes Ifosfamide 50.0 mg/ml >240 minutes Mechlorethamine HCI 1.0 mg/ml >240 minutes Melphalan 5 mg/ml >240 minutes Methotrexate 25 mg/ml >240 minutes Mitomycin C 0.5 mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >240 minutes Paclitaxel (Taxol) 6.0 mg/ml >240 minutes Paraplatin 10 mg/ml >240 minutes Rituximab 10 mg/ml >240 minutes Thiotepa 10.0 mg/ml 13.8 (13.8, 16.4, 14.8) minutes Vincristine Sulfate 1.0 mg/ml >240 minutes Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K191915
Methodology: https://510kreport.com/methodology