Cleared Traditional

K042618 - LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR)

K042618 is an FDA 510(k) clearance for LAGLOVE BRAND DOUBLE POLYMER COATED NIT..., manufactured by La Glove (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code FMC cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K042618 · La Glove (M) Sdn. Bhd. · General Hospital
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Nov 2004
Decision
60d
Days
Class 1
Risk

K042618 is an FDA 510(k) clearance for the LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE -.... Classified as Patient Examination Glove (product code FMC), Class I - General Controls.

Submitted by La Glove (M) Sdn. Bhd. (Kajang Selangpr D.E., MY). The FDA issued a Cleared decision on November 26, 2004 after a review of 60 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6250 - 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

FDA 510(k) Submission Details - K042618

510(k) Number K042618 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2004
Decision Date November 26, 2004
Days to Decision 60 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
69d faster than avg
Panel avg: 129d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

FMC Device Classification - Class 1, General Controls

Product Code FMC Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
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 - FMC Patient Examination Glove

All 15
Devices cleared under the same product code (FMC) and FDA review panel - the closest regulatory comparables to K042618.
BLOSSOM POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MCGM OR LESS OF TOTAL WATER EXTRACTA
K992337 · Mexpo Intl., Inc. · Aug 1999
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404 · Safeskin Corp. · May 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405 · Safeskin Corp. · May 1994
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923175 · Ulti-Med Intl., Inc. · Jun 1993
COMFIT, PATIENT EXAMINATION GLOVES
K903746 · Wembley Rubber Products (M) Sdn Bhd · Sep 1990
ROCKET SEX CRIME KIT
K883805 · A & A Medical, Inc. · Jan 1989