Cleared Traditional

K001165 - POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K001165 is an FDA 510(k) clearance for POLYMER COATED POWDER FREE, manufactured by Medipure Corporation (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 86-day FDA review.

K001165 · Medipure Corporation (M) Sdn. Bhd. · General Hospital
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Jul 2000
Decision
86d
Days
Class 1
Risk

K001165 is an FDA 510(k) clearance for the POLYMER COATED POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LAB.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Medipure Corporation (M) Sdn. Bhd. (Kuala Kangsar, Perak, MY). The FDA issued a Cleared decision on July 5, 2000 after a review of 86 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 Medipure Corporation (M) Sdn. Bhd. devices

FDA 510(k) Submission Details - K001165

510(k) Number K001165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2000
Decision Date July 05, 2000
Days to Decision 86 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
43d faster than avg
Panel avg: 129d · This submission: 86d
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 592
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K001165.
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
K002175 · Sgmp Co., Ltd. · Jul 2000
NON-STERILE POWDER FREE PINEAPPLE SCENTED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS LE
K002176 · Sgmp Co., Ltd. · Jul 2000
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN P
K001739 · Allegiance Healthcare Corp. · Jul 2000
HEALTH-PLUS, SANITEX, RELIANCE PRE-POWDERED LATEX EXAMINATION GLOVES - BLUE COLOR
K000952 · Pamitex Industries Sdn Bhd · Jun 2000
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K001674 · Pamitex Industries Sdn Bhd · Jun 2000
POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES
K001672 · Pamitex Industries Sdn Bhd · Jun 2000