Cleared Traditional

K001959 - POWDERED STERILE LATEX SURGICAL GLOVE

K001959 is the FDA 510(k) clearance for POWDERED STERILE LATEX SURGICAL GLOVE by Hartalega Sdn Bhd. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K001959 · Hartalega Sdn Bhd · General Hospital
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Jul 2000
Decision
29d
Days
Class 1
Risk

K001959 is an FDA 510(k) clearance for the POWDERED STERILE LATEX SURGICAL GLOVE, WITH PROTEIN CONTENT LABELING CLAIM (2.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by Hartalega Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on July 26, 2000 after a review of 29 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 Hartalega Sdn Bhd devices

Submission Details

510(k) Number K001959 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 27, 2000
Decision Date July 26, 2000
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 143
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K001959.
ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES
K011721 · Allegiance Healthcare Corp. · Aug 2001
ULTRAFREE MAX STERILE LATEX POWEDER-FREE SURGICAL GLOVES WITH PROTEIN LABELING CLAIM, 50 PER GRAM OR LESS OF TOTAL WATER
K010862 · Allegiance Healthcare Corp. · Jun 2001
POWDER FREE STERILE LATEX SURGICAL GLOVES, CONTAINS 50 MICROGRAM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K002593 · Hartalega Sdn Bhd · Nov 2000
COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0
K001924 · Allegiance Healthcare Corp. · Jul 2000
ULTRADERM STERILE LATEX POWDERED SURGICAL SLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K991205 · Allegiance Healthcare Corp. · Oct 1999
COATED STERILE LATEX POWDER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K992171 · Allegiance Healthcare Corp. · Sep 1999