# K193217: SensiCare PI and SensiCare PI Micro Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 6, 2020 after 137 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
The surgeons glove is a disposable device made of synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. In addition, these gloves were tested for use with chemotherapy drugs in accordance with ASTM D6978 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. The following chemicals have been tested with these gloves. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes SensiCare Pl Bleomycin (15 mg/ml) 240 minutes Busulfan (6 mg/ml) 240 minutes Carboplatin (10.0 mg/ml) 240 minutes Carmustine (3.3 mg/ml) 12.4 minutes (12.4, 14.4, 12.4) 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 (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) 12.4 minutes (12.4, 13.4, 13.2) Vincristine Sulfate (1.0 mg/ml) 240 minutes Warning: Do not use with Carmustine and Thiotepa SensiCare PI Micro 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 12.4 (13.1, 13.8, 12.4) 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 Epirubicin (Ellence) 2 mg/ml Etoposide (Toposar) 20.0 mg/ml 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 10.0 mg/ml 240 minutes Rituximab 10 mg/ml 240 minutes Thiotepa 10.0 mg/ml 22.3 (22.3, 23.9, 23.2) minutes Vincristine Sulfate 1.0 mg/ml 240 minutes Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K193217
Methodology: https://510kreport.com/methodology