Cleared Traditional

K994013 - POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MICROGRAMS OR LESS)

K994013 is an FDA 510(k) clearance for POWDERED LATEX EXAMINATION GLOVES WITH ..., manufactured by Glovco (M) Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K994013 · Glovco (M) Sdn. Bhd. · General Hospital
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Jan 2000
Decision
55d
Days
Class 1
Risk

K994013 is an FDA 510(k) clearance for the POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (100 MI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Glovco (M) Sdn. Bhd. (Klang, Selangor D.E., MY). The FDA issued a Cleared decision on January 20, 2000 after a review of 55 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 Glovco (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K994013

510(k) Number K994013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1999
Decision Date January 20, 2000
Days to Decision 55 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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex That May Or May Not Bear A Trace Amount Of Residual Powder, And Is Intended To Be Worn On The Hand For Medical Purposes 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 - LYY Latex Patient Examination Glove

All 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K994013.
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) (50 MICROGRAM OR LESS)
K994082 · Besglove Medicare Sdn. Bhd. · Jan 2000
COLORED AND FLAVORED POWDER FREE LATEX EXAMINATION GLOVES
K993864 · Supermax Sdn Bhd · Jan 2000
GREEN PEPPERMINT FLAVORED POWDERED LATEX EXAMINATION GLOVES
K993865 · Supermax Sdn Bhd · Jan 2000
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
K993567 · Innovative Gloves Co;, Ltd. · Jan 2000
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
K993793 · Guthrie Medicare Products (Melaka) Sdn Bhd · Jan 2000
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
K994043 · Biopro (M) Sdn Bhd · Jan 2000