# K990677: Absogel Chemotheraphy Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Ampri Rubberware Industries Sdn Bhd
- Decided: Nov 1, 1999 after 244 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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. The extra thickness of this glove is suitable for use in an environment of higher risks, such as Paramedics, Emergency Room, etc. This glove may also provide additional protection in other areas where users are handling certain hazardous chemicals such as chemotherapy drugs, as penetration and permeation to these chemicals are prevented.

Source page: https://510kreport.com/device/K990677
Methodology: https://510kreport.com/methodology