Cleared Traditional

K001674 - POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR

K001674 is an FDA 510(k) clearance for POWDER-FREE LATEX EXAMINATION GLOVES-BL..., manufactured by Pamitex Industries Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K001674 · Pamitex Industries Sdn Bhd · General Hospital
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Jun 2000
Decision
29d
Days
Class 1
Risk

K001674 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pamitex Industries Sdn Bhd (Darul Khusus, MY). The FDA issued a Cleared decision on June 30, 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 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 Pamitex Industries Sdn Bhd devices

FDA 510(k) Submission Details - K001674

510(k) Number K001674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 2000
Decision Date June 30, 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.

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 812
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K001674.
POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K001165 · Medipure Corporation (M) Sdn. Bhd. · Jul 2000
POWDERED PATIENT EXAMINATION GLOVES, LATEX
K001715 · Fitco Dipped Products Pvt., Ltd. · Jul 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
K000952 · Pamitex Industries Sdn Bhd · Jun 2000
HANWELLA LATEX PATIENT EXAM. GLOVES POWDER-FREE
K000351 · Hanwella Rubber Products , Ltd. · Jun 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · Pamitex Industries Sdn Bhd · Jun 2000
HEALTH-PLUS, SANITEX, RELIANCE, POWDERED LATEX EXAM GLOVES CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PR
K001475 · Pwa Industries Sdn. Bhd. · Jun 2000