Cleared Traditional

K010486 - POLYMER COATED POWDER-FREE GREY COLOR P...

K010486 is the FDA 510(k) clearance for POLYMER COATED POWDER-FREE GREY COLOR P... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K010486 · Pt. Medisafe Technologies · General Hospital
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Apr 2001
Decision
49d
Days
Class 1
Risk

K010486 is an FDA 510(k) clearance for the POLYMER COATED POWDER-FREE GREY COLOR POLYCHLOROPRENE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, ID). The FDA issued a Cleared decision on April 10, 2001 after a review of 49 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 Pt. Medisafe Technologies devices

Submission Details

510(k) Number K010486 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 2001
Decision Date April 10, 2001
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LZA Polymer Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Nitrile (or Polymer) Patient Examination Glove Is A Disposable Device Made Of Nitrile Rubber Or Synthetic Polymers 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 - LZA Polymer Patient Examination Glove

All 555
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K010486.
NITRILE POWDER-FREE EXAMINATION GLOVES
K023170 · Allegiance Healthcare Corp. · Oct 2002
POWDER-FREE BUTADIENE COPOLYMER EXAM GLOVES WITH ALOE, VITAMINS E PH5.5
K011961 · Shen Wei (Usa), Inc. · Sep 2001
SAFESKIN NEON NITRILE - POWDER FREE NEON EXAM GLOVE
K011713 · Kimberly-Clark Corp. · Jul 2001
POWDER-FREE NITRILE EXAMINATION GLOVES, WHITE
K010110 · Shen Wei (Usa), Inc. · Apr 2001
POWDER-FREE NITRILE EXAMINATION GLOVES WITH ALOE VERA, GREEN (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K010097 · Shen Wei (Usa), Inc. · Mar 2001
MEDLINE ALOE TOUCH STERILE NITRILE EXAMINATION GLOVES WITH ALOE VERA
K003353 · Medline Industries, Inc. · Nov 2000