# K192988: Dermasure Green Sterile SyntheticPolychloroprene Powder-Free Surgical Glove Tested for Use

- Pathway: 510(k) (Traditional)
- Applicant: Medline Industries, Inc.
- Decided: Apr 1, 2020 after 159 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 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 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) 38.5 minutes (57.2, 57.3, 38.5) 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) 38.6 minutes (39.0, 39.3, 38.6) Vincristine Sulfate (1.0 mg/ml) >240 minutes Caution: Testing showed a minimum breakthrough time of 38.5 minutes for Carmustine and 38.6 minutes for Thiotepa.

Source page: https://510kreport.com/device/K192988
Methodology: https://510kreport.com/methodology