Cleared Traditional

K143477 - Nitrile Patient Examination gloves

K143477 is an FDA 510(k) clearance for Nitrile Patient Examination gloves, manufactured by Primus Gloves Pvt Limited. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 496-day FDA review.

K143477 · Primus Gloves Pvt Limited · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2016
Decision
496d
Days
Class 1
Risk

K143477 is an FDA 510(k) clearance for the Nitrile Patient Examination gloves, Powderfree, Blue color. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Primus Gloves Pvt Limited (Cochin, IN). The FDA issued a Cleared decision on April 14, 2016 after a review of 496 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Primus Gloves Pvt Limited devices

FDA 510(k) Submission Details - K143477

510(k) Number K143477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2014
Decision Date April 14, 2016
Days to Decision 496 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
367d slower than avg
Panel avg: 129d · This submission: 496d
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 730
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K143477.
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
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
K160560 · Hartalega Sdn Bhd · Aug 2016
Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU)
K151997 · Hartalega NGC Sdn. Bhd. · Mar 2016
Powder Free Polychloroprene Examination Glove Green
K153510 · Terang Nusa Sdn Bhd · Mar 2016
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK
K151836 · Hartalega NGC Sdn. Bhd. · Oct 2015