# K230217: Sterile Polyisoprene Powder Free Surgical Glove, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: May 13, 2023 after 107 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 K013302 (2001). 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)
- K221718: Polyisoprene Powder Free Surgical Glove Tested for Use with Chemotherapy Drugs (Natural), Hartalega NGC Sdn. Bhd. (2022) Summary page 4.

## 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 D6978-05(Reapproved 2019). Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Carmustine (3.3mg/ml) 25.4 Cisplatin (1mg/ml) >240 Cyclophosphamide (20mg/ml) >240 Doxorubicin HCL (2 mg/ml) >240 Etoposide (20mg/ml) >240 Fluorouracil (50mg/ml) >240 Methotrexate (25mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Paclitaxel (6mg/ml) >240 Thiotepa (10mg/ml) 23.3 Vincristine Sulfate (1mg/ml) >240 Please note that the following drugs have low permeation times: Carmustine (BCNU): 25.4 minutes, Thiotepa: 23.3 minutes Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K230217
Methodology: https://510kreport.com/methodology