Cleared Traditional

K863637 - UPDATED STERILE GOWNS, MASKS AND TOWELS (FDA 510(k) Clearance)

K863637 · Biological & Environmental Control Laboratories · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1986
Decision
12d
Days
-
Risk

K863637 is an FDA 510(k) clearance for the UPDATED STERILE GOWNS, MASKS AND TOWELS.

Submitted by Biological & Environmental Control Laboratories (Toledo, US). The FDA issued a Cleared decision on September 29, 1986 after a review of 12 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 Biological & Environmental Control Laboratories devices

Submission Details

510(k) Number K863637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 1986
Decision Date September 29, 1986
Days to Decision 12 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
102d faster than avg
Panel avg: 114d · This submission: 12d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code -
Device Class -