# K203538: SensiCare PI Ortho LT Surgical Glove (Tested for Use with Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Aug 2, 2021 after 242 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 surgeon's glove is a disposable device made of synthetic rubber latex intended to be worn by surgeon's and or 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 the glove. Chemotherapy Drug Permeation (Breakthrough Detection Time) in Minutes. Bleomycin 15 mg/ml >240 minutes Busulfan 6 mg/ml >240 minutes Carboplatin 10.0 mg/ml >240 minutes Carumstine (BCNU) 3.3 mg/ml 25.8 minutes (25.8, 34.1, 35.4) Cisplatin 1.0 mg/ml >240 minutes Cyclophosphamide (Cytoxan) 20 mg/ml >240 minutes Cytarabine 100 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 lfosfamide 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 0.5mg/ml >240 minutes Mitoxantrone 2.0 mg/ml >40 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 34.6 minutes (37.5, 37.8, 34.6) Vincristine Sulfate 1.0 mg/ml >240 minutes Warning: Do not use with Carmustine Caution: Testing showed a minimum breakthrough time of 34.6 minutes with Thiotepa

Source page: https://510kreport.com/device/K203538
Methodology: https://510kreport.com/methodology