Cleared Traditional

PRE-POWDERED NITRILE EXAMINATION GLOVES

K974442 · P.T. Latexindo Tobaperkasa · Orthopedic
Jan 1998
Decision
41d
Days
Class 2
Risk

About This 510(k) Submission

K974442 is an FDA 510(k) clearance for the PRE-POWDERED NITRILE EXAMINATION GLOVES, a Prosthesis, Hip, Hemi-, Femoral, Metal Ball (Class II — Special Controls, product code LZY), submitted by P.T. Latexindo Tobaperkasa (Medan, ID). The FDA issued a Cleared decision on January 5, 1998, 41 days after receiving the submission on November 25, 1997. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3360.

Submission Details

510(k) Number K974442 FDA.gov
FDA Decision Cleared SESE
Date Received November 25, 1997
Decision Date January 05, 1998
Days to Decision 41 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Statement

Device Classification

Product Code LZY — Prosthesis, Hip, Hemi-, Femoral, Metal Ball
Device Class Class II — Special Controls
CFR Regulation 21 CFR 888.3360