Cleared Traditional

K001047 - GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED)

K001047 is an FDA 510(k) clearance for GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED), manufactured by Guthrie Medicare Products (Melaka) Sdn Bhd. The device is a Class 1 General Hospital device with product code KGO cleared through the Traditional 510(k) pathway after a 28-day FDA review.

K001047 · Guthrie Medicare Products (Melaka) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
28d
Days
Class 1
Risk

K001047 is an FDA 510(k) clearance for the GUTHRIE LATEX SURGICAL GLOVE (PRE-POWDERED). Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Guthrie Medicare Products (Melaka) Sdn Bhd (Great Neck, US). The FDA issued a Cleared decision on April 28, 2000 after a review of 28 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 Guthrie Medicare Products (Melaka) Sdn Bhd devices

FDA 510(k) Submission Details - K001047

510(k) Number K001047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2000
Decision Date April 28, 2000
Days to Decision 28 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d faster than avg
Panel avg: 129d · This submission: 28d
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 312
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K001047.
NUZONE NITRILE SURGICAL GLOVES, POWDERED, GREEN
K000178 · Terang Nusa Sdn Bhd · May 2000
NUZONE NITRILE SURGICAL GLOVES POWDER FREE
K000179 · Terang Nusa Sdn Bhd · May 2000
ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K001239 · Ansell Perry · May 2000
HEALTH-PLUS, SANITEX, RELIANCE STERILE POWDER-FREE NITRILE SURGICAL GLOVES
K993756 · Pamitex Industries Sdn Bhd · Apr 2000
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 2000
HEALTH-PLUS, SANITEX, RELIANCE POWEDER-FREE STERILE LATEX SURGICAL GLOVES
K993201 · Pamitex Industries Sdn Bhd · Mar 2000