# K062138: Powder Free Sterile Nitrile Examination Gloves, Blue; Powder Free Polychloroprene Sterile Examination Glove

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Oct 5, 2006 after 71 days
- Product code: LZA (Polymer 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 K000868 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000868: Non-Sterile Powder-Free, Blue Nitrile Examination Gloves, Sgmp Co., Ltd. (2000) Summary page 1.

## Indications for use
This is a medical glove to be 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/K062138
Methodology: https://510kreport.com/methodology