# K171898: Sterile Polyisoprene Powder Free Surgical Gloves, Tested for Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Better Care Plastic Technology Co., Ltd.
- Decided: Aug 18, 2017 after 53 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152428: SensiCare PI Surgical Gloves, Medline Industries, Inc. (2016) Summary page 5.

## Indications for use
This glove is 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. The following chemicals have been tested with these gloves. The tested chemotherapy drugs’ breakthrough detection times are listed as follows: Chemotherapy Drug Minimum BDT Carmustine, 3.3 mg/ml 16.0 min. Cisplatin, 1.0 mg/ml >240 min. Cyclophosphamide (Cytoxan) , 20 mg/ml >240 min. Doxorubicin Hydrochloride, 2.0 mg/ml >240 min. Etoposide (Toposar) , 20.0 mg/ml >240 min. Fluorouracil, 50.0 mg/ml >240 min. Methotrexate, 25 mg/ml >240 min. Paclitaxel (Taxol) , 6.0 mg/ml >240 min. Thiotepa, 10.0 mg/ml 16.6 min. Vincristine Sulfate, 1.0 mg/ml >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 16.0 minutes; and Thiotepa (10.0 mg/ml) has a minimum breakthrough time of 16.6 minutes. WARNING: Do not use with Carmustine and Thio-Tepa.

Source page: https://510kreport.com/device/K171898
Methodology: https://510kreport.com/methodology