# K021000: Shanghai Glovmax Enterprise Powdered Blue Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Glovmax Enterprise Co.,Ltd
- Decided: May 31, 2002 after 64 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
A powdered patient examintaion glove is a disposable device made of naturai rubber latex or synthetic material that bears powder to facilitate donning and is intended to be worn on the hand or fingers (s) for medical purposes to provide a barrier against potentially infectious materials and other contaminants.

Source page: https://510kreport.com/device/K021000
Methodology: https://510kreport.com/methodology