# K212613: Powder Free Nitrile Examination Gloves, Non-sterile,Tested For Use with Chemotherapy Drugs and Opioid Fentanyl Citrate (Blue)

- Pathway: 510(k) (Traditional)
- Applicant: Koon Seng Sdn Bhd
- Decided: Dec 21, 2021 after 125 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: 2 generations back to K183287 (2019). 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)
- K192954: Power Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Comfort Rubber Gloves Industries Sdn. Bhd. (2020) Summary page 4.

## Indications for use
A Nitrile powder free examination glove is a disposable device intended for medical purposes, worn on the examiner's hand or finger to prevent contamination between examiner and patient. This specialty glove has also been tested with Chemotherapy drugs and the Opioid Fentanyl citrate. Chemotherapy Drugs and the opioid Fentanyl citrate were tested for breakthrough detection times: TEST CONCENTRATION MINIMUM BREAKTHROUGH CHEMOTHERAPY DRUG TESTED DETECTION TIME (MINUTES) Carmustine (BCNU) 3.3 mg/mi 13.0 Cisplatin 1.0 mgml No Breakthrough Up To 240 minutes Cyclophosphamide (Cytoxan) 20.0 mg/ml No Breakthrough Up To 240 minutes Cylarabine 100.0 mg/ml No Breakthrough Up To 240 minutes Dacarbazine (DTIC) 10.0 mg/ml No Breakthrough Up To 240 minutes Doxorubicin Hydrochloride 2.0 mg/mi No Breakthrough Up To 240 minutes Etoposide (Toposar) 20.0 mg/ml No Breakthrough Up To 240 minutes Fluorouracil 50.0 mg/ml No Breakthrough Up To 240 minutes Ifosfamide 50 0 mg/m I No Breakthrough Up To 240 minutes Methotrexate 25.0 mg/ml No Breakthrough Up To 240 minutes Mitomycin C 0.5 mg/mI No Breakthrough Up To 240 minutes Mitoxantrone 2.0 mg/ml No Breakthrough Up To 240 minutes Paclitaxel (Taxol) 6.0 mgimI No Breakthrough Up To 240 minutes Thiotepa 10.0 mg/ml 37.9 Vincristine Sulfate 1.0 mg/mi No Breakthrough Up To 240 minutes Important: Carmustine and Thiotepa have extremely low minimal breakthrough times of 13.0 minutes and 37.9 minutes respectively. Warning: Do not use with Carmustine or Thiotepa. TEST OPIOID DRUG Fentanyl Citrate (Injectable) CONCENTRATION TESTED 100 0 mg/2ml I MINIMUM BREAKTHROUGH DETECTION TIME (MINUTES) No Breakthrough up to 240 minutes

Source page: https://510kreport.com/device/K212613
Methodology: https://510kreport.com/methodology