# K180452: White Nitrile Examination Glove, Sterile with Chemotherapy Drugs Claim

- Pathway: 510(k) (Traditional)
- Applicant: Riverstone Resources Sdn Bhd
- Decided: Jun 12, 2018 after 112 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: 4 generations back to K042805 (2004). 7 ancestors in all.
3 later devices descend 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)
- K161187: EMG Blue Nitrile Examination Gloves Powder Free with Tested for use with Chemotherapy Drugs, Eco Medi Glove Sdn. Bhd. (2016) Summary page 5.
- K171093: Sterile Nitrile Patient Examination Gloves, Powderfree, Sanrea Healthcare Products Pvt, Ltd. (2017) Summary page 5.

## Most influential descendants
- K190725: Nitrile Examination Glove Sterile Tested for use with Chemotherapy Drugs Claim, White (2019), 2 descendants of its own
- K220250: Sterile Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs (2022), 1 descendant of its own
- 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
The White Nitrile Examination Glove,Sterile, is a disposable device intended for medical purposes that is worn on the examinerls 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 D6978-05 standards: Practice for assessment of Medical Glove to Permeation by chemotherapy Drugs Chemotherapy Drugs and Concentration Minimum Breakthrough detection time in minutes,0.0 I pg/cm2/minute Carmustine (BCNU)(3.3 mg/ml) 17.1 Minutes Cyclophosphamide (20 mg/ml) > 240 Minutes Cisplatin (1.0 mg/ml) > 240 Minutes Dacarbazine (DTIC) (10 mg/ml) > 240 Minutes Doxorubicin Hydrochloride (2.0 mg/ml) > 240 Minutes Etoposide (20 mg/ml) > 240 Minutes Fluorouracil (50 mg/ml) > 240 Minutes Paclitaxel (6.0 mg/ml) > 240 Minutes Thiotepa (10 mg/ml) 55.9 minutes The Maximum testing time is 240 Minutes.Please note that the following drugs have extremely low permeartion time: Carmustine (BCNU)(3.3mg/ml) Thiotepa ( 10mg/ml)

Source page: https://510kreport.com/device/K180452
Methodology: https://510kreport.com/methodology