# K222907: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate

- Pathway: 510(k) (Traditional)
- Applicant: Rmkh Glove (Cambodia) Co., Ltd.
- Decided: Jan 4, 2023 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: 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 5.

## Indications for use
The Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl Citrate is a specialty medical glove which is a disposable device intended for medical purpose that is worn on the examiner’s hand or finger to prevent contamination between examiner and patient. The glove was tested for use with Chemotherapy Drugs and Fentanyl Citrate as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Tested chemotherapy drugs are as follows: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Carmustine 3.3 mg/ml 22.6 Minutes Cisplatin 1.0 mg/ml 240 Minutes Cyclophosphamide 20.0 mg/ml 240 Minutes Dacarbazine 10.0 mg/ml 240 Minutes Doxorubicin HCI 2.0 mg/ml 240 Minutes Etoposide 20.0 mg/ml 240 Minutes Fluorouracil 50.0 mg/ml 240 Minutes Methotrexate 25.0 mg/ml 240 Minutes Mitomycin C 0.5 mg/ml 240 Minutes Paclitaxel 6.0 mg/ml 240 Minutes ThioTepa 10.0 mg/ml 11.0 Minutes Vincristine Sulfate 1.0 mg/ml 240 Minutes Please note that the following drugs have low permeation times: Carmustine 3.3 mg/ml 22.6 Minutes; ThioTepa 10.0 mg/ml 11.0 Minutes. Tested Fentanyl Citrate is as follows: Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Fentanyl Citrate Injection 100.0 mcg/2ml 240 Minutes

Source page: https://510kreport.com/device/K222907
Methodology: https://510kreport.com/methodology