# K152428: SensiCare PI Surgical Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Mar 31, 2016 after 218 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: 3 generations back to K011721 (2001). 4 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110272: Sterile Polyisoprene Powder-Free Surgical Gloves Tested for Use with Chemotherapy Drug, Cardinal Health, Inc. (2011) Summary page 5.

## Most influential descendants
- K171898: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs (2017), 0 descendants of its own
- K161823: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs (2017), 0 descendants of its own

## Indications for use
The SensiCare PI surgeon's 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 Carmustine (BCNU) 3.3 mg/ml (3,300 ppm) 10.1 min. (10.1, 10.1, 10.1) Cisplatin 1.0 mg/ml (1,000 ppm) 240 min. Cyclophosphamide (Cytoxan) 20 mg/ml (20,000 ppm) 240 min. Cytarabine 100 mg/ml (100,000 ppm) 240 min. Dacarbazine (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. Mitomycin C 0.5 mg/ml (500 ppm) 240 min. Mitoxantrone 2.0 mg/ml (2,000 ppm) 240 min. Paclitaxel (Taxol) 6.0 mg/ml (6,000 ppm) 240 min. Thiotepa 10.0 mg/ml (10,000 ppm) 11.6 min. (20.2, 21.5, 11.6) Vincristine Sulfate 1.0 mg/ml (1,000 ppm) 240 min. Please note that the following drugs have extremely low permeation time of less than 30 minutes: Carmustine (3.3 mg/ml) has a minimum breakthrough time of 10.1 minutes; Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 11.6 minutes.

Source page: https://510kreport.com/device/K152428
Methodology: https://510kreport.com/methodology