Cleared Traditional

K140816 - POWDER FREE NITRILE EXAMINATION GLOVE

K140816 is an FDA 510(k) clearance for POWDER FREE NITRILE EXAMINATION GLOVE, manufactured by Better Care Plastic Technology Co., Ltd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 98-day FDA review.

K140816 · Better Care Plastic Technology Co., Ltd. · General Hospital
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Jul 2014
Decision
98d
Days
Class 1
Risk

K140816 is an FDA 510(k) clearance for the POWDER FREE NITRILE EXAMINATION GLOVE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Better Care Plastic Technology Co., Ltd. (Chino, US). The FDA issued a Cleared decision on July 8, 2014 after a review of 98 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 Better Care Plastic Technology Co., Ltd. devices

FDA 510(k) Submission Details - K140816

510(k) Number K140816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2014
Decision Date July 08, 2014
Days to Decision 98 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
31d faster than avg
Panel avg: 129d · This submission: 98d
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 683
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K140816.
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - DKBU /DARK BLUE
K140050 · Hartalega Sdn Bhd · Sep 2014
DERMAGRIP POWDER FREE BLUE NITRILE PATIENT EXAMINATION GLOVES, NON-STERILE
K133168 · Wrp Asia Pacific Sdn. Bhd. · Aug 2014
NITRILE POWDER FREE EXAMINATION GLOVES (WHITE/DAWN BLUE/DARK VIOLET BLUE (DVBU)/COBALT BLUE (CBLU)
K140890 · Hartalega NGC Sdn. Bhd. · Jul 2014
NITRILE POWDER FREE EXAMINATION GLOVE - AQUA BLUE (ABLU) / VIOLET BLUE (VBLU) / DARK BLUE (DKBU)
K140610 · Hartalega NGC Sdn. Bhd. · Jun 2014
NON STERILE, POWEDER FREE BLUE NITRILE EXAMINATION GLOVES - 8623F
K133123 · Yty Industry (Manjung) Sdn Bhd · May 2014
NITRILE POWDER FREE EXAMINATION GLOVE WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG - WHITE / DAWN BLUE / LEMON GREEN
K133956 · Hartalega Sdn Bhd · May 2014