Cleared Traditional

K910920 - PROTEKT GLOVES (FDA 510(k) Clearance)

Class I General & Plastic Surgery device.

K910920 · Intermedics Orthopedics · General & Plastic Surgery device
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May 1991
Decision
71d
Days
Class 1
Risk

K910920 is an FDA 510(k) clearance for the PROTEKT GLOVES. Classified as Dress, Surgical (product code FYE), Class I - General Controls.

Submitted by Intermedics Orthopedics (Austin, US). The FDA issued a Cleared decision on May 15, 1991 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4040 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Intermedics Orthopedics devices

Submission Details

510(k) Number K910920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 1991
Decision Date May 15, 1991
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 114d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FYE Dress, Surgical
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4040
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.