# K213289: Gammex® PI Plus Glove-in-Glove™ System Tested For Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Ansell Healthcare Products, LLC
- Decided: May 26, 2023 after 602 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 K081180 (2008). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190077: Biogel® PI UltraTouch S Surgical Glove, Biogel® Pl Ultra Touch S Indicator Underglove, Molnlycke Health Care Us, LLC (2019) Summary page 5.

## Indications for use
A powder-free surgeons' glove is intended to be worn by operating room personnel to protect a surgical wound from contamination. The glove system was tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy testing was carried out on the system as a whole, including both the under-glove & outer-glove together. Please note that the following drugs have extremely low permeation times: Carmustine: 35.0 minutes and Thiotepa: 67.0 minutes. Warning: Do not use with Carmustine or Thiotepa. Test Chemotherapy drug & Concentration Average Breakthrough Detection Time (Minutes) Bleomycin - 15.0 mg/ml >240 Busulfan - 6.0 mg/ml >240 Carboplatin - 10 mg/ml >240 Carmustine - 3.3 mg/ml 35.0 Cisplatin - 1.0 mg/ml >240 Cyclophosphamide - 20.0 mg/ml >240 Cytarabine HCl - 100.0 mg/ml >240 Dacarbazine - 10.0 mg/ml >240 Daunorubicin HCI - 5.0 mg/ml >240 Docetaxel - 10.0 mg/ml >240 Doxorubicin HCl 2.0 mg/ml >240 Epirubicin - 2.0 mg/ml >240 Etoposide - 20.0 mg/ml >240 Fludarabine - 25 mg/ml >240 Fluorouracil - 50.0 mg/ml >240 Gemcitabine - 38.0 mg/ml >240 Idarubicin - 1.0 mg/ml >240 Ifosfamide - 50.0 mg/ml >240 Irinotecan - 20.0 mg/ml >240 Mechlorethamine HCI - 1.0 mg/ml >240 Melphalan - 5.0 mg/ml >240 Methotrexate - 25.0 mg/ml >240 Mitomycin C - 0.5 mg/ml >240 Mitoxantrone - 2.0 mg/ml >240 Oxaliplatin - 2.0 mg/ml >240 Paclitaxel - 6.0 mg/ml >240 Rituximab - 10.0 mg/ml >240 Thiotepa - 10.0 mg/ml 67.0 Vincristine Sulfate - 1.0 mg/ml >240

Source page: https://510kreport.com/device/K213289
Methodology: https://510kreport.com/methodology