# K161422: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Wrp Asia Pacific Sdn. Bhd.
- Decided: Oct 20, 2016 after 150 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: 3 generations back to K042805 (2004). 4 ancestors in all.
9 later devices descend from it; 3 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K141982: Dermagrip Powder Free Blue Nitrile Patient Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs, Wrp Asia Pacific Sdn. Bhd. (2015) Summary page 5.

## Most influential descendants
- K171171: KS Medicare Powder Free Nitrile Examination Gloves, Non-sterile, Tested for Use with Chemotherapy Drugs (Blue, Black) (2018), 5 descendants of its own
- K190403: Disposable Powder Free Nitrile Examination Glove, White, Tested for Use With Chemotherapy Drugs, Disposable Powder Free Nitrile Examination Glove, Blue, Tested for Use With Chemotherapy Drugs (2019), 4 descendants of its own
- K193555: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate (2020), 3 descendants of its own
- K244034: Disposable Powder Free Nitrile Examination Glove, Blue Color, Tested For Use With Chemotherapy Drugs and Fentanyl Citrate and Xylazine (2025), 1 descendant of its own
- K214110: Nitrile Powder Free Blue Patient Examination Gloves Non-Sterile, Tested For Use With Chemotherapy Drugs (2022), 1 descendant 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 as per ASTM D6978-05 Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs: Chemotherapy Drug Permeation The following chemicals have been tested with these gloves. Chemotherapy Drug Concentration Breakthrough Detection Time in Minutes Flourouracil (Adrucil) 50.0mg/ml > 240 Etopside (Toposar) 20.0mg/ml >240 Cyclophosphamide (Cytoxan) 20.0mg/ml > 240 *Carmustine (BCNU) 3.3mg/ml 15.0 *Thiotepa 10.0mg/ml 2.0 Paclitaxel (Taxol) 6.0mg/ml > 240 Doxorubicin Hydrochloride (Adriamycin) 2.0mg/ml > 240 Dacarbazine 10.0mg/ml > 240 Cisplatin 1.0mg/ml > 240 Ifosfamide 50.0mg/ml > 240 Mitoxantrone 2.0mg/ml > 240 Vincristine Sulfate 1.0mg/ml > 240 Methotrexate 25mg/ml > 240 Mitomycin C 0.5mg/ml > 240 * Please note that the-following drugs have extremely low permeation times: Carmustine (BCNU) : 15 minutes and Thiotepa : 2 minutes

Source page: https://510kreport.com/device/K161422
Methodology: https://510kreport.com/methodology