# K212898: Blue Nitrile Powder Free Patient Examination Glove, Non-Sterile, Tested For Use With Chemotherapy Drugs

- Pathway: 510(k) (Traditional)
- Applicant: Rimba Glove Snd Bhd
- Decided: Dec 16, 2021 after 97 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: 8 generations back to K042805 (2004). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210944: Powder Free Nitrile Examination Glove, Tested for Use with Chemoterapy Drugs (Blue), Harbour Health, LLC (2021) Summary page 6.

## 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 per ASTM D6978-05(2019) Standard Practice for assessment of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Breakthrough Detection Time in Minutes *Carmustine (BCNU) 23.0 Cisplatin > 240 Cyclophosphamide (Cytoxan) > 240 Dacarbazine > 240 Doxorubicin HCI > 240 Etoposide > 240 Fluorouracil > 240 Ifosfamide > 240 Methotrexate > 240 Mitomycin C > 240 Mitoxantrone > 240 Paclitaxel > 240 *Thiotepa 98.8 Vincristine Sulfate > 240 *CAUTION: Testing showed an average breakthrough time of 23.0 minutes for Carmustine and an average breakthrough time of 98.9 minutes for Thiotepa. **WARNING: DO NOT USE WITH CARMUSTINE.

Source page: https://510kreport.com/device/K212898
Methodology: https://510kreport.com/methodology