SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE)— 510(k) K010297

Clearance details

Applicant

Maxxim Medical

Product code

Code LZA

Device class

Class 1

Regulation

21 CFR 880.6250

Advisory panel

General Hospital

Date received

2001-01-31

Decision date

2001-02-16

Decision

Substantially Equivalent

Clearance type

Special

Location

Hone Path, SC, US

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Other

1

Total

1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →