Cleared Traditional

K951473 - ULTIMAX

K951473 is an FDA 510(k) clearance for ULTIMAX, manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K951473 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Jul 1995
Decision
109d
Days
Class 1
Risk

K951473 is an FDA 510(k) clearance for the ULTIMAX. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Malaysia, MY). The FDA issued a Cleared decision on July 17, 1995 after a review of 109 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 Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K951473

510(k) Number K951473 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date July 17, 1995
Days to Decision 109 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 129d · This submission: 109d
Pathway characteristics
Predicate-based equivalence.

KGO Device Classification - Class 1, General Controls

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 268
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K951473.
MAXXUS ORTHOPAEDIC SURGICAL GLOVES
K953641 · Johnson & Johnson Medical, Inc. · Sep 1995
SAFESKIN SUPRA
K952993 · Safeskin Corp. · Aug 1995
SAFESKIN SUPRA
K953015 · Safeskin Corp. · Aug 1995
PROFEEL
K951661 · Wembley Rubber Products (M) Sdn Bhd · May 1995
COMFIT/BEADED SURGEON'S GLOVE
K951662 · Wembley Rubber Products (M) Sdn Bhd · May 1995
SCIPOTEX POWDER FREE SURGICAL GLOVES (BEADED)
K943254 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995