Cleared Traditional

K120110 - ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET

K120110 is an FDA 510(k) clearance for ELEGANT NITRILE POWDER FREE EXAMINATION..., manufactured by Profit Point Manufacturing Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 265-day FDA review.

K120110 · Profit Point Manufacturing Sdn Bhd · General Hospital
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Oct 2012
Decision
265d
Days
Class 1
Risk

K120110 is an FDA 510(k) clearance for the ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Profit Point Manufacturing Sdn Bhd (Kluang, MY). The FDA issued a Cleared decision on October 4, 2012 after a review of 265 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.

FDA 510(k) Submission Details - K120110

510(k) Number K120110 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 2012
Decision Date October 04, 2012
Days to Decision 265 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
136d slower than avg
Panel avg: 129d · This submission: 265d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K120110.
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131 · Matang Mfg. Sdn. Bhd. · Oct 2012
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLOR
K121992 · Xinwei (Shandong) Plastic and Rubber Products Co., · Oct 2012
MIDAS TOUCH, NITRILE EXAMINATION GLOVES, POWDER-FREE, PINK
K122465 · Industrial Clothings, Ltd. · Oct 2012
POWDER FREE BLACK NITRILE EXAMINATION GLOVES
K113393 · Tg Medical Sdn. Bhd. · Sep 2012
POWER-FREE NITRILE EXAMINATION GLOVES, PEPPERMINT SCENTED, BLUE COLOR
K121528 · Shen Wei (Usa), Inc. · Sep 2012
ETS BLUE POWDER-FREE PATIENT NITRILE EXAMINATION GLOVES
K121947 · Northstar Healthcare Holdings · Sep 2012
K120110 · ELEGANT NITRILE POWDER FREE EXAMINATION GLOVE BLUE VIOLET
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