# K161823: Powder Free Nitrile Surgical Glove, Sterile, Tested for use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Jan 23, 2017 after 206 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: 4 generations back to K011721 (2001). 8 ancestors in all.
No later device cites it as a predicate yet.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153316: Cardinal Health Sterile Neoprene Powder-Free Surgical Gloves with Nitrile Coating and Tested for Use with Chemotherapy Drugs (Yellow), Cardinal Health, Inc. (2016) Summary page 5.
- K152428: SensiCare PI Surgical Gloves, Medline Industries, Inc. (2016) Summary page 5.

## Indications for use
A surgeon's glove is a device made of natural or synthetic rubber intended to be worn by operating room personnel to protect a surgical wound from contamination. These gloves were tested for use with Chemotherapy Drugs as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3mg/ml 30.4 Cisplatin 1.0mg/ml > 240 Cyclophosphamide (Cytoxan) 20.0mg/m! >240 Dacarbazine 10.0mg/ml > 240 Doxorubicin Hydrochloride 2.0mg/mi > 240 Etoposide (Toposar) 20.0mg/ml > 240 Fluorouracil 50.0mg/ml > 240 Ifosfamide 50.0mg/ml > 240 Mitoxantrone 2.0mg/ml > 240 Paclitaxel (Taxol) 6.0mg/ml > 240 *Thiotepa - 10.0mg/mi 59.0 Vingristine Sulfate 1.0mg/ml > 240 CAUTION: Testing showed an average breakthrough time of 30.4 minutes for Carmustine and an average breakthrough time of 59.0 minutes for Thiotepa.

Source page: https://510kreport.com/device/K161823
Methodology: https://510kreport.com/methodology