Cleared Traditional

K162113 - Powder Free Nitrile Examination Gloves (Blue)

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 1172
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162113.
Powder Free Polychloroprene Examination Glove Blue, Powder Free Polychloroprene Examination Glove Pink
K161932 · Terang Nusa Sdn Bhd · Nov 2016
Synthetic Nitrile Patient Examination Gloves, Powder Free, Blue Color, and Tested for Use with Chemotherapy Drugs
K161944 · Shandong Baisheng Medical Products Co., Ltd. · 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