# K211666: Powder Free Nitrile Examination Gloves, Blue Chemotest

- Pathway: 510(k) (Traditional)
- Applicant: Careglove Global Sdn. Bhd.
- Decided: Jan 9, 2022 after 222 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: 1 generation back to K162858 (2017). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162858: Nitrilecare Nitrile Examination Gloves Powder Free, Blue, Chemotest, Careplus (M) Sdn Bhd (2017) Summary page 5.

## 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 Drugs Permeation The following chemicals have been tested with these gloves. Chemotherapy Drugs Concentration Breakthrough Detection Time in Minutes *Carmustine (BCNU) 3.3 mg/ml 22.6 Cisplatin 1.0 mg/ml >240 min Cyclophosphamide (Cytoxan) 20.0 mg/ml >240 min Dacarbazine 10.0 mg/ml >240 min Doxorubicin HCL 2.0 mg/ml >240 min Etoposide 20.0 mg/ml >240 min Fluorouracil 50.0 mg/ml >240 min Ifosfamide 50.0 mg/ml >240 min Mitoxantrone 2 mg/ml >240 min Paclitaxel 6.0 mg/ml >240 min *Thio Tepa 10.0 mg/ml >43.9 Vincristine Sulfate 1.0 mg/ml >240 min *WARNING: Not recommended for use with Carmustlne and Thlotepa. Please note that following drugs have extremely low permeation times: Carmustine (BCNU): 22.6 minutes and Thiotepa: 43.9 munites

Source page: https://510kreport.com/device/K211666
Methodology: https://510kreport.com/methodology