Cleared Traditional

GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT. (K915636) - FDA 510(k) Clearance

K915636 · Associated Ent., Inc. · General & Plastic Surgery device
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Jul 1992
Decision
209d
Days
-
Risk

K915636 is an FDA 510(k) clearance for the GLOVE CHECK PATIENT EXAMINATION GLOVE LEAK DETECT..

Submitted by Associated Ent., Inc. (Jonesborough, US). The FDA issued a Cleared decision on July 13, 1992 after a review of 209 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 Associated Ent., Inc. devices

Submission Details

510(k) Number K915636 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1991
Decision Date July 13, 1992
Days to Decision 209 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
94d slower than avg
Panel avg: 115d · This submission: 209d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LDQ
Device Class -