# K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Special)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: Aug 9, 2023 after 30 days
- Product code: LZA (Polymer Patient Examination Glove)
- Device class: 1
- Regulation: 21 CFR 880.6250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K042805 (2004). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs, Grand Work Plastic Products Co., Ltd. (2022) Summary page 6.

## Indications for use
The glove is disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between patient and examiner. In addition, these gloves were tested for use with Chemotherapy drugs and fentanyl citrate in accordance with ASTM D6978. Chemotherapy Drug Minimum BDT (Minutes) Carmustine (BCNU) (3.3mg/ml) 54.3 Cyclophosphamide (20mg/ml) >240 Doxorubicin Hydrochloride (2 mg/ml) >240 Etoposide (20mg/ml) >240 Fluorouracil (50mg/ml) >240 Paclitaxel (6mg/ml) >240 Thiotepa (10mg/ml) 196.7 Methotrexate (25mg/ml) >240 Cisplatin (1mg/ml) >240 Vincristine Sulfate (1.0 mg/ml) >240 Cytarabine HCL (100mg/ml) >240 Mitoxantrone (2.0 mg/ml) >240 Mitomycin C (0.5 mg/ml) >240 Ifosfamide (50.0 mg/ml) >240 Dacarbazine (DTIC) (10.0 mg/ml) >240 Opioid Drug Minimum BDT (Minutes) Fentanyl Citrate Injection (100mcg/2mL) >240 Caution: Please note that the following drugs have low permeation times: Carmustine (BCNU): 54.3 minutes, Thiotepa: 196.7 minutes

Source page: https://510kreport.com/device/K232039
Methodology: https://510kreport.com/methodology