# K203036: Non Sterile Powder Free Polyurethane Examination Gloves (Blue and Black colors)

- Pathway: 510(k) (Traditional)
- Applicant: Central Medicare Sdn Bhd
- Decided: May 7, 2021 after 214 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K222892: Powder Free Polyurethane Examination Gloves, Blue color, Tested for use with Chemotherapy Drugs (2022), 0 descendants of its own

## Indications for use
Non Sterile Powder Free Polyurethane Examination Glove (Blue and Black colors) is a disposable device intended for medical purposed that is worn on the examiner’s hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K203036
Methodology: https://510kreport.com/methodology