Cleared Traditional

K954002 - AMPRI

K954002 is an FDA 510(k) clearance for AMPRI, manufactured by Ampri Rubberware Industries Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K954002 · Ampri Rubberware Industries Sdn Bhd · General Hospital
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Jan 1996
Decision
157d
Days
Class 1
Risk

K954002 is an FDA 510(k) clearance for the AMPRI. Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Ampri Rubberware Industries Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on January 29, 1996 after a review of 157 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

FDA 510(k) Submission Details - K954002

510(k) Number K954002 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 1995
Decision Date January 29, 1996
Days to Decision 157 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
28d slower than avg
Panel avg: 129d · This submission: 157d
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 311
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K954002.
COMFIT ORTHOPEDIC
K960407 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
COMFIT MICROPTIC
K960416 · Wembley Rubber Products (M) Sdn Bhd · Apr 1996
POWDER FREE TACTYLON SURGEONS GLOVE
K955419 · Tactyl Technologies, Inc. · Apr 1996
NEUTRALON BROWN LATEX SURGICAL GLOVES
K953639 · Johnson & Johnson Medical, Inc. · Oct 1995
MICRO-TOUCH* LATEX SURGICAL GLOVES
K954049 · Johnson & Johnson Medical, Inc. · Oct 1995
MAXXUS ORTHOPAEDIC SURGICAL GLOVES
K953641 · Johnson & Johnson Medical, Inc. · Sep 1995