# K981159: Proflex Powder Free Nitrile Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Latexx Partners Bhd.
- Decided: Jun 1, 1998 after 62 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 1 patient examination glove (Nitrile) 80LZA: named in the summary without a submission number

## Indications for use
Proflex Powderfree Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

Source page: https://510kreport.com/device/K981159
Methodology: https://510kreport.com/methodology