Cleared Traditional

K992018 - LAGLOVE POWDERED LATEX SURGICAL GLOVES ...

K992018 is the FDA 510(k) clearance for LAGLOVE POWDERED LATEX SURGICAL GLOVES ... by La Glove (M) Sdn. Bhd.. It is a Class 1 General Hospital device (product code KGO) cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K992018 · La Glove (M) Sdn. Bhd. · General Hospital
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Jul 1999
Decision
44d
Days
Class 1
Risk

K992018 is an FDA 510(k) clearance for the LAGLOVE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (1.... Classified as Surgeon's Gloves (product code KGO), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on July 30, 1999 after a review of 44 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 La Glove (M) Sdn. Bhd. devices

Submission Details

510(k) Number K992018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1999
Decision Date July 30, 1999
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
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 162
Devices cleared under the same product code (KGO) and FDA review panel - the closest regulatory comparables to K992018.
PROFEEL POWDER FREE NITRILE SURGICAL GLOVE, STERILE
K000971 · Wrp Asia Pacific Sdn. Bhd. · Apr 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
ULTRAFREE THICK STERILE LATEX POWDER-FREE SURGICAL GLOVES
K991992 · Allegiance Healthcare Corp. · Jul 1999
PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
K982600 · Wembley Rubber Products (M) Sdn Bhd · Mar 1999
ULTRALON POWDER FREE LATEX SURGICAL GLOVE
K973699 · Johnson & Johnson Medical, Inc. · Dec 1997