# K213408: BPG ChemoPlus Nitrile Patient Examination Gloves, Powder Free

- Pathway: 510(k) (Traditional)
- Applicant: Meditech Gloves Sdn Bhd
- Decided: Apr 17, 2022 after 180 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.
3 later devices descend from it; 1 cites it directly.
0 of 6 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.

## Most influential descendants
- K230121: Nitrile Examination Gloves Powder Free Tested For Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (2023), 2 descendants of its own
- K250578: Nitrile Examination Gloves Powder Free Tested for Use With Chemotherapy Drugs & Fentanyl Citrate (Blue & Black) (2025), 0 descendants of its own
- K232252: Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black), Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Orange) (2023), 0 descendants of its own

## Indications for use
A patient examination glove 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. These gloves were tested for use with chemotherapy drugs and Fentanyl Citrate per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug and Concentration Minimum Breakthrough Detection Time (Minutes) Azacitidine, 25mg/ml (25,000 ppm) >240mins Bleomycin Sulphate 15mg/ml (15,000 ppm) >240mins Carboplatin 10mg/ml (10,000 ppm) >240mins Carmustine (BCNU) 3.3mg/ml (3300 ppm) 22.5mins Cetuximab 2mg/ml (2000 ppm) >240mins Cisplatin Img/ml (1000 ppm) >240mins Cyclophosphamide (Cytoxan) 20mg/ml (20,000 ppm) >240mins Dacarbazine 10mg/ml (10,000 ppm) >240mins Docetaxel 10mg/ml (10,000 ppm) >240mins Doxorubicin HCI 2mg/ml (2,000 ppm) >240mins Ellence (Epirubicin) 2mg/ml (2,000 ppm) >240mins Etoposide 20mg/ml (20,000 ppm) >240mins Fluorouracil 50mg/ml (50,000 ppm) >240mins Gemcitabine 38mg/ml (38,000 ppm) >240mins Ifosfamide 50mg/ml (50,000 ppm) >240mins Irinotecan 20mg/ml (20,000 ppm) >240mins Methotrexate 25mg/ml (25,000ppm) >240mins Mitomycin C 0.5mg/ml (500 ppm) >240mins Mitoxantrone 2mg/ml (2,000 ppm) >240mins Oxaliplatin 2mg/ml (2,000ppm) >240mins Paclitaxel 6mg/ml (6,000 ppm) >240mins Rituximab 10mg/ml (10,000 ppm) >240mins Thio Tepa 10 mg/ml (10,000 ppm) 36.1 mins Vincristine Sulfate 1mg/ml 1,000 ppm) >240mins Vinorelbine 10mg/ml (10,000 ppm) >240mins Tested for Fentanyl Citrate is as follows: Fentanyl Citrate 100mcg/2ml ~ >240mins Please note the following drugs have low permeation times Camustine (BCNU) 3.3mg/ml 22.5mins Thio Tepa 10mg/ml 36.1mins Warning: Do not use these gloves with Camustine or Thio Tepa.

Source page: https://510kreport.com/device/K213408
Methodology: https://510kreport.com/methodology