Cleared Traditional

K050968 - POWDERFREE POLYCHLOROPRENE STERILE EXAM...

K050968 is the FDA 510(k) clearance for POWDERFREE POLYCHLOROPRENE STERILE EXAM... by Pt. Medisafe Technologies. It is a Class 1 General Hospital device (product code LZA) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K050968 · Pt. Medisafe Technologies · General Hospital
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Jul 2005
Decision
85d
Days
Class 1
Risk

K050968 is an FDA 510(k) clearance for the POWDERFREE POLYCHLOROPRENE STERILE EXAMINATION GLOVES. 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 July 12, 2005 after a review of 85 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 K050968 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 18, 2005
Decision Date July 12, 2005
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 K050968.
TEXTURED POWDER FREE NITRILE EXAM GLOVES (BLACK COLOR), CHEMO LABELING
K060073 · Shen Wei (Usa), Inc. · May 2006
NITRILE POWDER FREE EXAMINATION GLOVES (BLUE)
K051777 · Hartalega Sdn Bhd · Aug 2005
NITRILE POWDERED EXAMINATION GLOVES (BLUE)
K051778 · Hartalega Sdn Bhd · Jul 2005
KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE
K051347 · Kimberly-Clark Corp. · Jun 2005
POWDER FREE BUTADIENE EXAM GLOVES WITH ALOE, GREEN
K050467 · Shen Wei (Usa), Inc. · Mar 2005
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE)
K050214 · Hartalega Sdn Bhd · Mar 2005