# K081971: Bioclean Chemo Ultimate Powder Free Polychloroprene Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Nitritex (M) Sdn. Bhd.
- Decided: Dec 23, 2008 after 166 days
- Product code: LZC (Medical Glove, Specialty)
- 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: named in the summary without a submission number

## Indications for use
A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. Tested for use with Chemotherapy Drugs

Source page: https://510kreport.com/device/K081971
Methodology: https://510kreport.com/methodology