Cleared Traditional

K172015 - POWDER FREE NITRILE EXAMINATION GLOVES

K172015 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVES, manufactured by Careglove Global Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K172015 · Careglove Global Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2017
Decision
85d
Days
Class 1
Risk

K172015 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVES, BLUE (COLORED). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Careglove Global Sdn. Bhd. (Seremban, MY). The FDA issued a Cleared decision on September 26, 2017 after a review of 85 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 Careglove Global Sdn. Bhd. devices

FDA 510(k) Submission Details - K172015

510(k) Number K172015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 2017
Decision Date September 26, 2017
Days to Decision 85 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
44d faster than avg
Panel avg: 129d · This submission: 85d
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 685
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K172015.
THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
K172678 · Shen Wei (Usa), Inc. · Nov 2017
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K172442 · Hartalega NGC Sdn. Bhd. · Nov 2017
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant and Tested for Use With Chemotherapy Drugs (Dawn Blue)
K171874 · Hartalega Sdn Bhd · Oct 2017
Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Blue, Cobalt Blue)
K171104 · Yty Industry (Manjung) Sdn Bhd · Aug 2017
Biodegradable Powder Free Nitrile Exam Gloves with Aloe Vera, Green Color
K162312 · Shen Wei (Usa), Inc. · Jul 2017
Nitrile Examination Gloves, Powder Free [Purple] Tested for Use with Chemotherapy Drugs
K170686 · Brightway Holdings Sdn. Bhd. · Jul 2017