Cleared Traditional

K901237 - GLOVE LEAK DETECTOR (FDA 510(k) Clearance)

K901237 · Utah Medical Products, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
159d
Days
-
Risk

K901237 is an FDA 510(k) clearance for the GLOVE LEAK DETECTOR.

Submitted by Utah Medical Products, Inc. (Midvale, US). The FDA issued a Cleared decision on August 21, 1990 after a review of 159 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Utah Medical Products, Inc. devices

Submission Details

510(k) Number K901237 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1990
Decision Date August 21, 1990
Days to Decision 159 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
45d slower than avg
Panel avg: 114d · This submission: 159d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -