# K232444: Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: Dec 20, 2023 after 128 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: 2 generations back to K983489 (1998). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K202765: ENCORE Latex Textured Surgical Gloves, Powder Free with Protein Content Labeling Claim (50 micrograms or less) and Tested for use with Chemotherapy drugs, Careplus (M) Sdn Bhd (2021) Summary page 6.

## Indications for use
The 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. Chemotherapy Drug Minimum Breakthrough Detection Time (BDT) in Minutes Bleomycin Sulfate 15mg/ml (15000 ppm) >240 Busulfan 6mg/ml (6,000 ppm) >240 Carboplatin 10mg/ml (10,000 ppm) >240 Carmustine (BCNU)3.3 mg/ml (3,300 ppm) 14.0 Cisplatin 1mg/ml (1,000 ppm) >240 Cyclophosphamide 20mg/ml (20,000 ppm) >240 Cytarabine HCL, 100 mg/ml (100,000 ppm) >240 Dacarbazine 10 mg/ml (10,000 ppm) >240 Doxorubicin HCL, 2 mg/ml (2,000 ppm) >240 Etoposide, 20 mg/ml (20,000 ppm) >240 Epirubicin HCL, 2 mg/ml (2,000 ppm) >240 Fludarabine, 25 mg/ml (25,000 ppm) >240 Fluorouracil, 50mg/ml (50,000ppm) >240 Idarubicin HCL, 1mg/ml (1,000ppm) >240 Ifosfamide, 50mg/ml (50,000ppm) >240 Mechlorethamine HCI, 1mg/ml (1,000ppm) >240 Melphalan, 5mg/ml (5,000ppm) >240 Methotrexate, 25mg/ml (25,000ppm) >240 Mitomycin C, 0.5mg/ml (500ppm) >240 Mitoxantrone HCL, 2mg/ml (2,000ppm) >240 Paclitaxel, 6mg/ml (6,000ppm) >240 Paraplatin, 10mg/ml (10,000ppm) >240 Rituximab, 10mg/ml (10,000ppm) >240 Thio Tepa, 10mg/ml (10,000ppm) 16.1 Vincristine Sulfate, 1mg/ml (1,000ppm) >240 Please note that the following drugs have low permeation times: Carmustine (BCNU): 14.0 minutes, Thiotepa: 16.1 minutes Warning: Do not use with Carmustine and Thiotepa

Source page: https://510kreport.com/device/K232444
Methodology: https://510kreport.com/methodology