# K990210: Powdered Latex Examination Gloves with Protein Content Labeling Claim (100 Micrograms or Less of Total Water Extractabp

- Pathway: 510(k) (Traditional)
- Applicant: Mexpo Intl., Inc.
- Decided: Mar 29, 1999 after 67 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
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
of total water extractable Protein per gram). A medical glove is worn on the hand of health care and similar personnel to prevent contamination between health care personnel and the patient.

Source page: https://510kreport.com/device/K990210
Methodology: https://510kreport.com/methodology