Cleared Traditional

LATEX EXAMINATION GLOVES (K944778) - FDA 510(k) Clearance

K944778 · Pt. Haloni Jane · General & Plastic Surgery device
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Nov 1994
Decision
51d
Days
-
Risk

K944778 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVES.

Submitted by Pt. Haloni Jane (Medan, ID). The FDA issued a Cleared decision on November 17, 1994 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Pt. Haloni Jane devices

Submission Details

510(k) Number K944778 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1994
Decision Date November 17, 1994
Days to Decision 51 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 115d · This submission: 51d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code OPE
Device Class -