Cleared Traditional

K162113 - Powder Free Nitrile Examination Gloves ...

K162113 is an FDA 510(k) clearance for Powder Free Nitrile Examination Gloves ..., manufactured by Nam Viet Glove Joint Stock Company. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K162113 · Nam Viet Glove Joint Stock Company · General Hospital
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Nov 2016
Decision
101d
Days
Class 1
Risk

K162113 is an FDA 510(k) clearance for the Powder Free Nitrile Examination Gloves (Blue). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Nam Viet Glove Joint Stock Company (Ho Chi Minh, VN). The FDA issued a Cleared decision on November 7, 2016 after a review of 101 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 Nam Viet Glove Joint Stock Company devices

FDA 510(k) Submission Details - K162113

510(k) Number K162113 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 29, 2016
Decision Date November 07, 2016
Days to Decision 101 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
28d faster than avg
Panel avg: 129d · This submission: 101d
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 742
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162113.
Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs
K161215 · Brightway Holdings Sdn. Bhd. · Dec 2016
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
K161932 · Terang Nusa Sdn Bhd · Nov 2016
Powder Free Nitrile Examination Gloves Flock-Lined, Black Color
K161074 · Shen Wei (Usa), Inc. · Nov 2016
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
K162095 · Yty Industry (Manjung) Sdn Bhd · Nov 2016
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K161422 · Wrp Asia Pacific Sdn. Bhd. · Oct 2016
Medline Powder-Free Nitrile Exam Glove Extended Cuff (Tested for Use with Chemotherapy Dr)
K161473 · Medline Industries, Inc. · Oct 2016