# K200093: Synthetic Nitrile Patient Exam Gloves, Powder Free, Blue, Tested for Use w/Chemotherapy Drug

- Pathway: 510(k) (Traditional)
- Applicant: Anhui Lntco Medical Products Co., Ltd.
- Decided: Aug 20, 2020 after 217 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The synthetic nitrile patient examination gloves, powder free, blue color and tested for use with chemotherapy drugs are disposable devices intended for medical purposes that is worn on the examiner's hands or fingers to prevent contamination between patient and examiner. The glove was tested for use with chemotherapy drugs as per ASTM D6978-05 (Reapproved 2019) Standard Practice for Assessment of Medical Gloves to Permeation by Chemotherapy Drugs. 1. CAUTION: Testing showed an average breakthrough time of 46.9 minutes with Thiotepa and 22.6 minutes with Carmustine 2. WARNING: Do not use with Carmustine.

Source page: https://510kreport.com/device/K200093
Methodology: https://510kreport.com/methodology