Cleared Traditional

K102623 - BLUE POWDERFREE NITRILE EXAMINATION GLOVE

K102623 is an FDA 510(k) clearance for BLUE POWDERFREE NITRILE EXAMINATION GLOVE, 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 266-day FDA review.

K102623 · Pt. Medisafe Technologies · General Hospital
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Jun 2011
Decision
266d
Days
Class 1
Risk

K102623 is an FDA 510(k) clearance for the BLUE POWDERFREE NITRILE EXAMINATION GLOVE. 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 June 6, 2011 after a review of 266 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pt. Medisafe Technologies devices

FDA 510(k) Submission Details - K102623

510(k) Number K102623 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 2010
Decision Date June 06, 2011
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
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 909
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K102623.
POWDER FREE NITRILE (BLACK) EXAMINATION GLOVES
K110297 · Comfort Rubber Gloves Industries Sdn. Bhd. · Jun 2011
POWDER FREE NUTRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K110247 · Jiangsu Dongling Plastic & Rubber Co., Ltd. · Jun 2011
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WHITE COLOR
K110248 · Jiangsu Dongling Plastic & Rubber Co., Ltd. · Jun 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110155 · Tangshan Xiangrui Plastic Products Co., Ltd. · May 2011
POWDERFREE NITRILE EXAMINATION GLOVES COATED WITH ALLOGEL,COLORS BLUE,MAGNETA,COPPER AND WITHOUT ALLOGEL,COLORS BLUE,MAG
K110102 · Preventive Care, Inc. · May 2011
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES
K110146 · Tangshan Kaiyue Glove Co., Ltd. · May 2011