# K973664: Latex Exam Glove, Powder-Free W/Protein  & Hypoallergenic Labeling

- Pathway: 510(k) (Traditional)
- Applicant: Evergrade Healthcare Products Sdn Bhd
- Decided: Mar 13, 1998 after 169 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: 1 generation back to K955918 (1996). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955918: Sinochem Ningbo Latex Examination Glove, Powder Free, Sinochem Ningbo Imp & Exp Corp. (1996) Summary page 1.

## Most influential descendants
- K992031: Latex Examination Glove Powder Free, with Protein Labeling Claim (50 Micrograms or Less Total Water Soluble Protein) (1999), 0 descendants of its own

## 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/K973664
Methodology: https://510kreport.com/methodology