Cleared Special

K010483 - POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0

K010483 is an FDA 510(k) clearance for POWDERFREE COLORED LATEX EXAMINATION GL..., manufactured by Pt. Medisafe Technologies. The device is a Class 1 General Hospital device with product code LYY cleared through the Special 510(k) pathway after a 72-day FDA review.

K010483 · Pt. Medisafe Technologies · General Hospital
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May 2001
Decision
72d
Days
Class 1
Risk

K010483 is an FDA 510(k) clearance for the POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, ID). The FDA issued a Cleared decision on May 3, 2001 after a review of 72 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K010483

510(k) Number K010483 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date May 03, 2001
Days to Decision 72 days
Submission Type Special
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
57d faster than avg
Panel avg: 129d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K010483.
POWDER-FREE LATEX EXAMINATION GLOVES-BLUE COLOR
K010803 · Hwa Teh Industrial Sdn. Bhd. · May 2001
UNIGLOVE POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K010879 · N.S. Uni-Gloves Sdn. Bhd. · May 2001
POWDER-FREE LATEX EXAMINATION GLOVE, BLUE COLORED
K011271 · Perusahaan Getah Asas Sdn. Bhd. · May 2001
ULTRA CARE 2 LATEX EXAMINATION GLOVES MADE FROM ALLOTEX (ENZYME TREATED) NATURAL RUBBER LATEX WITH A PROTEIN CONTENT LAB
K002718 · Tillotson Healthcare Corp. · May 2001
HEALTH-PLUS, SANITEX, RELIANCE MULTIPLY POWDER FREE POLYMER AND NITRILE COATED (BLUE)
K003350 · Pamitex Industries Sdn Bhd · Apr 2001
LATEX EXAMINATION GLOVES-POWDERED, NONSTERILE
K010347 · Enzymic Technologies Sdn Bhd · Mar 2001
K010483 · POWDERFREE COLORED LATEX EXAMINATION GLOVES (PINK, BLUE, GREEN, AND WHITE) WITH PROTEIN CONTENT LABELING CLAIM (50 MICR0
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