# K992031: Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein)

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Changzheng Latex Factory
- Decided: Jul 12, 1999 after 26 days
- Product code: LYY (Latex 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
Longest line of descent: 2 generations back to K955918 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K973664: Latex Exam Glove, Powder-Free W/Protein  & Hypoallergenic Labeling, Evergrade Healthcare Products Sdn Bhd (1998) Summary page 1.

## 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.

Source page: https://510kreport.com/device/K992031
Methodology: https://510kreport.com/methodology