# K212532: Disposable Powder Free Nitrile Exam Gloves (Tested For Use With Chemotherapy Drugs)

- Pathway: 510(k) (Traditional)
- Applicant: Crdlight Optoelectronic Technology Co., Ltd.
- Decided: Nov 11, 2021 after 92 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 K051378 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200960: Medline Powder Free Examination Gloves (Tested for use with Chemotherapy Drugs), Medline Industires, Inc. (2020) Summary page 4.

## Indications for use
Disposable Powder Free Nitrile Exam Glove (Tested For Use With Chemotherapy Drugs) is a disposable device intended for medical purposes that is worn on the examiner’s hand to prevent contamination between patient and examiner. Summarized in Table below, the proposed device was tested for use with chemotherapy drugs per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Resistance of Medical Gloves to Permeation by Chemotherapy Drugs. Chemotherapy Drug Concentration (mg/mL) Breakthrough time (minutes) Carmustine (BCNU) 3.3 mg/mL 6.2min Cisplatin 1.0 mg/mL >240min Cyclophosphamide (Cytoxan) 20.0 mg/mL >240min Dacarbazine (DTIC) 10.0 mg/mL >240min Doxorubicin HCL (Adriamycin) 2.0 mg/mL >240min Etoposide (Toposar) 20.0 mg/mL >240min Fluorouracil (Adrucil) 50.0 mg/mL >240min Paclitaxel (Taxol) 6.0 mg/mL >240min ThioTEPA 10.0 mg/mL 8.4min Methotrexate 25.0 mg/mL >240min Vincristine sulfate 1.0 mg/mL >240min Do not use with Carmustine or ThioTEPA.

Source page: https://510kreport.com/device/K212532
Methodology: https://510kreport.com/methodology