Cleared Traditional

K162510 - Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue

K162510 is an FDA 510(k) clearance for Non-Sterile, manufactured by Ug Global Resources Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 313-day FDA review.

K162510 · Ug Global Resources Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2017
Decision
313d
Days
Class 1
Risk

K162510 is an FDA 510(k) clearance for the Non-Sterile, Powder-Free, Nitrile Examination Gloves, Blue. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Ug Global Resources Sdn. Bhd. (Seremban, MY). The FDA issued a Cleared decision on July 18, 2017 after a review of 313 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Ug Global Resources Sdn. Bhd. devices

FDA 510(k) Submission Details - K162510

510(k) Number K162510 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2016
Decision Date July 18, 2017
Days to Decision 313 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
184d slower than avg
Panel avg: 129d · This submission: 313d
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 1157
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K162510.
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · Shen Wei (Usa), Inc. · Jul 2017
Xingyu Powder Free Nitrile Patient Examination Gloves, Blue color
K171616 · Shandong Xingyu Gloves Co., Ltd. · Jul 2017
STERILE NITRILE PATIENT EXAMINATION GLOVES, POWDERFREE
K171093 · Sanrea Healthcare Products Pvt, Ltd. · Jul 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686 · Brightway Holdings Sdn. Bhd. · Jul 2017
Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Polymer Coated, Tested for Use with Chemotherapy Drugs
K170397 · Kossan International Sdn Bhd · Jul 2017
DilaCheck Nitrile Powder Free Examination Glove, (Sterile)
K163035 · Elm Tree Medical, Inc. · Jul 2017