Cleared Traditional

K850635 - ANSELL NO POWDER SURGEON'S GLOVES

K850635 is the FDA 510(k) clearance for ANSELL NO POWDER SURGEON'S GLOVES by Ansell, Inc.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K850635 · Ansell, Inc. · General Hospital
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Jun 1985
Decision
127d
Days
Class 1
Risk

K850635 is an FDA 510(k) clearance for the ANSELL NO POWDER SURGEON'S GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ansell, Inc. (Dothan, US). The FDA issued a Cleared decision on June 26, 1985 after a review of 127 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Ansell, Inc. devices

Submission Details

510(k) Number K850635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 19, 1985
Decision Date June 26, 1985
Days to Decision 127 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
2d faster than avg
Panel avg: 129d · This submission: 127d
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.

Regulatory Peers - KGO Surgeon's Gloves

All 169
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K850635.
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
REGENT DISPO STERILE BIOGEL STARCH FREE SURG GLOVE
K874099 · Biopro, Inc. · Dec 1987
NEUTRALON SURGICAL GLOVES
K861441 · Surgikos, Inc. · May 1986
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
VANISH
K833976 · Parke-Davis Co. · Feb 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984