Cleared Traditional

NITRILE RUBBER EXAMINATION GLOVES (POWERED) (K932405) - FDA 510(k) Clearance

Class I General Hospital device.

K932405 · Safeskin Corp. · General Hospital
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May 1994
Decision
370d
Days
Class 1
Risk

K932405 is an FDA 510(k) clearance for the NITRILE RUBBER EXAMINATION GLOVES (POWERED). Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by Safeskin Corp. (Boca Raton, US). The FDA issued a Cleared decision on May 18, 1994 after a review of 370 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - the FDA general hospital 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Safeskin Corp. devices

Submission Details

510(k) Number K932405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1993
Decision Date May 18, 1994
Days to Decision 370 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
241d slower than avg
Panel avg: 129d · This submission: 370d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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.