Cleared Traditional

K122999 - POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS

K122999 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES, manufactured by Top Glove Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K122999 · Top Glove Sdn. Bhd. · General Hospital
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Nov 2012
Decision
64d
Days
Class 1
Risk

K122999 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Top Glove Sdn. Bhd. (Klang, Selangor, MY). The FDA issued a Cleared decision on November 30, 2012 after a review of 64 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 Top Glove Sdn. Bhd. devices

FDA 510(k) Submission Details - K122999

510(k) Number K122999 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2012
Decision Date November 30, 2012
Days to Decision 64 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
65d faster than avg
Panel avg: 129d · This submission: 64d
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 1056
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K122999.
POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN)
K122408 · Hongye Plastic Products Co., Ltd. · Jan 2013
NON-STERILE, POWDER-FREE NITRILE EXAMINATION GLOVE, BLUE
K121549 · Siam Sempermed Corp., Ltd. · Dec 2012
POWDERED NITRILE EXAMINATION GLOVES, BLUE AND WHITE
K122874 · Nitrilist Gloves Manufacturing Sdn Bhd · Dec 2012
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE, WHITE AND GREEN COLORED. NON-STERILE, LOW DERMATITIS POTENTIAL
K120066 · Kossan Latex Industries(M)Sdn Bhd · Nov 2012
BLUE POWDERED NITRILE EXAMINATION GLOVE
K122998 · Northstar Healthcare Holdings · Nov 2012
POWDER FREE NITRILE EXAMINATION GLOVE-BLUE (CHEMOTHERAPY)
K122131 · Matang Mfg. Sdn. Bhd. · Oct 2012