# K141982: 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: Feb 5, 2015 after 199 days
- Product code: LZC (Medical Glove, Specialty)
- 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 K042805 (2004). 3 ancestors in all.
67 later devices descend from it; 7 cite it directly.
0 of 71 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081089: Kimberly-Clark Sterling Nitrile & Nitrile-Xtra Powder-Free Exam Gloves with Chemotherapy Drug Use Claim, Kimberly-Clark Corp. (2008) Summary page 5.

## Most influential descendants
- K163146: POWDER FREE Blue Nitrile GLOVES, Tested for Use with Chemotherapy Drugs (2017), 41 descendants of its own
- K172525: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2017), 39 descendants of its own
- K173942: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs (2018), 17 descendants of its own
- K182600: Powder Free Nitrile Examination Glove, Tested for Use with Chemotherapy Drugs (Blue) (2018), 13 descendants of its own
- K180646: Halyard Lavender Nitrile Powder-Free Exam Glove Tested for Use with Chemotherapy Drugs (2018), 9 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 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 * 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/K141982
Methodology: https://510kreport.com/methodology