Cleared Traditional

K082302 - POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM

K082302 is an FDA 510(k) clearance for POWDER FREE NITRILE PATIENT EXAMINATION..., 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 119-day FDA review.

K082302 · Pt. Medisafe Technologies · General Hospital
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Dec 2008
Decision
119d
Days
Class 1
Risk

K082302 is an FDA 510(k) clearance for the POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM. 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 December 9, 2008 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K082302

510(k) Number K082302 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 2008
Decision Date December 09, 2008
Days to Decision 119 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
10d faster than avg
Panel avg: 129d · This submission: 119d
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 1180
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K082302.
NON-STERILE, POWDERED NITRILE EXAMINATION GLOVE, BLUE
K081911 · Siam Sempermed Corp., Ltd. · Jan 2009
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K082598 · Tangshan Zhonghong Pulin Group Co., Ltd. · Jan 2009
BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES
K081972 · Nitritex (M) Sdn. Bhd. · Dec 2008
POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES
K081592 · Quality Gallant Sdn. Bhd. · Dec 2008
N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT
K082125 · Best Glove, Inc. · Nov 2008
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE)
K082457 · Ansell Healthcare Products, Inc. · Nov 2008
K082302 · POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM
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