Cleared Traditional

K040607 - MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES

K040607 is an FDA 510(k) clearance for MODIFICATION TO POWDERFREE COLORED AND ..., manufactured by Pt. Medisafe Technologies. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 45-day FDA review.

K040607 · Pt. Medisafe Technologies · General Hospital
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Apr 2004
Decision
45d
Days
Class 1
Risk

K040607 is an FDA 510(k) clearance for the MODIFICATION TO POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATI.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Medisafe Technologies (Medan, North Sumatra, ID). The FDA issued a Cleared decision on April 22, 2004 after a review of 45 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

FDA 510(k) Submission Details - K040607

510(k) Number K040607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2004
Decision Date April 22, 2004
Days to Decision 45 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
84d faster than avg
Panel avg: 129d · This submission: 45d
Pathway characteristics
Predicate-based equivalence.

LZA Device Classification - Class 1, General Controls

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 908
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K040607.
SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, TESTED FOR CHEMOTHERAPY
K042226 · Syntex Healthcare Products Co., Ltd. · Sep 2004
FREEFORM BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K041391 · Hartalega Sdn Bhd · Jul 2004
POWDER FREE NITRILE EXAMINATION GLOVES (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K040841 · Medline Industries, Inc. · Jul 2004
NON-STERILE BLUE & WHITE COLOUR POWDER FREE BARRIER PRO POLYBUTADIENE COPOLYMER EXAMINATION GLOVES
K033887 · Yty Industry (Manjung) Sdn Bhd · Mar 2004
NEOSOOTHE POLYMER COATED POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES WITH ALOE
K033086 · Pt. Medisafe Technologies · Feb 2004
ULTRASENSE AF BLUE POWDER-FREE NITRILE EXAMINATION GLOVES
K033777 · Syntex Healthcare Products Co., Ltd. · Feb 2004