Cleared Traditional

K121192 - NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK)

K121192 is an FDA 510(k) clearance for NITRILE EXAMINATION GLOVES (WHITE, manufactured by Tekmedic (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K121192 · Tekmedic (M) Sdn Bhd · General Hospital
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Aug 2012
Decision
106d
Days
Class 1
Risk

K121192 is an FDA 510(k) clearance for the NITRILE EXAMINATION GLOVES (WHITE, BLUE AND BLACK). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Tekmedic (M) Sdn Bhd (Tanjung Bruas Jetty, Tanjung Kling, MY). The FDA issued a Cleared decision on August 3, 2012 after a review of 106 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.

View all Tekmedic (M) Sdn Bhd devices

FDA 510(k) Submission Details - K121192

510(k) Number K121192 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date August 03, 2012
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
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 985
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K121192.
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES, BLUE
K122363 · Siam Sempermed Corp., Ltd. · Sep 2012
POWDER-FREE NITRIE EXAMINATION GLOVES, ORANGE
K120890 · Shen Wei (Usa), Inc. · Aug 2012
NITRILE EXAMINATION GLOVE, POWDER FREE (BLUE, BLACK OR WHITE)
K121368 · Matang Mfg. Sdn. Bhd. · Aug 2012
POWER-FREE NITRILE PATIENT EXAMINATION GLOVES
K121526 · Shandong Junchi Medical Products Co., Ltd. · Aug 2012
NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, COLORED (BLUE)
K120970 · Tangshan Zhonghong Pulin Plastic Co.,Ltd · Jul 2012
BLACK NITRILE POWDER-FREE EXAMINATION GLOVES
K121529 · Northstar Healthcare Holdings · Jul 2012