# K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Grand Work Plastic Products Co., Ltd.
- Decided: May 11, 2022 after 100 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: 6 generations back to K042805 (2004). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White, Riverstone Resources Sdn Bhd (2019) Summary page 4.

## Most influential descendants
- K232039: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (2023), 0 descendants of its own

## Indications for use
Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs is a disposable device intended for medical purposes 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 in accordance with ASTM D6978 standards. 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 (1Omg/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 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/K220250
Methodology: https://510kreport.com/methodology