Cleared Traditional

LATEX, IN-HOUSE COMPOUNDED (K781847) - FDA 510(k) Clearance

Class I General Hospital device.

K781847 · Arbrook Mfg. Corp. · General Hospital
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Nov 1978
Decision
1d
Days
Class 1
Risk

K781847 is an FDA 510(k) clearance for the LATEX, IN-HOUSE COMPOUNDED. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Arbrook Mfg. Corp. (Mchenry, US). The FDA issued a Cleared decision on November 3, 1978 after a review of 1 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4460 - 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: 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 Arbrook Mfg. Corp. devices

Submission Details

510(k) Number K781847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 1978
Decision Date November 03, 1978
Days to Decision 1 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
128d faster than avg
Panel avg: 129d · This submission: 1d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGO Surgeon's Gloves
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4460
Definition A Surgeon's Glove Is A Disposable Device Made Of Natural Rubber Latex Or Synthetic Polymers That May Or May Not Bear Powder To Facilitate Donning, And It Is Intended To Be Worn On The Hands, Usually In Surgical Settings, To Provide A Barrier Against Potentially Infectious Materials And Other Contaminants.
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.