# K970115: Powder Free Latex Examination Gloves

- Pathway: 510(k) (Traditional)
- Applicant: Pt Mbf Buana Multicorpora
- Decided: Aug 15, 1997 after 214 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.
1 later device descends from it; 1 cites it directly.
0 of 2 devices 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.

## Most influential descendants
- K022343: Glovetex Powder Free Latex Examination Gloves, Non Sterile (Protein Content Labeling Claim 50UG/G or Less) (2002), 0 descendants of its own

## Indications for use
Glove worn on hand of healthcare and similar personnel to prevent contamination between healthcare personnel and the patient's body, fluids, waste or environment.

Source page: https://510kreport.com/device/K970115
Methodology: https://510kreport.com/methodology