Cleared Traditional

GLOVES, APARTICULATE SURGICAL (K760248) - FDA 510(k) Clearance

Class I General Hospital device.

K760248 · Deknatel, Inc. · General Hospital
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Aug 1976
Decision
21d
Days
Class 1
Risk

K760248 is an FDA 510(k) clearance for the GLOVES, APARTICULATE SURGICAL. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Deknatel, Inc. (Fall River, US). The FDA issued a Cleared decision on August 9, 1976 after a review of 21 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 Deknatel, Inc. devices

Submission Details

510(k) Number K760248 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 1976
Decision Date August 09, 1976
Days to Decision 21 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
108d faster than avg
Panel avg: 129d · This submission: 21d
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.