# K030386: Powder Free Synthetic Nitrile Neoprene Examination Gloves, Sizes Small,Medium, Large, and X-Large

- Pathway: 510(k) (Traditional)
- Applicant: Shamrock Manufacturing Company
- Decided: Mar 28, 2003 after 51 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. The FDA summary names its predicate without a number.
- (no number) Class I Examination Gloves 80 LZA meeting ASTM D 6319-00: named in the summary without a submission number

## Indications for use
Powder free Synthetic Nitrile Neoprene Examination Gloves is a disposable device intended for medical purpose that is worn on examiner's hand to prevent contamination between patient and examiner.

Source page: https://510kreport.com/device/K030386
Methodology: https://510kreport.com/methodology