Cleared Traditional

CORRECT TOUCH SURGEONS GLOVES (K892176) - FDA 510(k) Clearance

Class I General Hospital device.

K892176 · Ampri Rubberware Industries Sdn Bhd · General Hospital
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Sep 1989
Decision
154d
Days
Class 1
Risk

K892176 is an FDA 510(k) clearance for the CORRECT TOUCH SURGEONS GLOVES. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ampri Rubberware Industries Sdn Bhd (Lumpur, Malaysia, MY). The FDA issued a Cleared decision on September 6, 1989 after a review of 154 days - an extended review 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: 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 Ampri Rubberware Industries Sdn Bhd devices

Submission Details

510(k) Number K892176 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1989
Decision Date September 06, 1989
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
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 97
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K892176.
TRIFLEX(R) ORTH STERILE SURGEON'S GLOVES, MODIFIED
K903987 · Baxter Healthcare Corp · Oct 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K902380 · Baxter Healthcare Corp · Jun 1990
TRIFLEX ORTHOPEDIC STERILE SURGEON'S GLOVE
K897192 · Baxter Healthcare Corp · Feb 1990
BDAC OMICRON PLUS SURGICAL GLOVES
K885271 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1989
SURGEON'S GLOVES
K842884 · Travenol Laboratories, S.A. · Nov 1984
TRIFLEX SURGEON'S GLOVES
K832448 · Travenol Laboratories, S.A. · Jan 1984