Cleared Traditional

K981064 - POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES

K981064 is an FDA 510(k) clearance for POWDERFREE COLORED AND FLAVORED CHLOROP..., manufactured by P.T. Irama Dinamika Latex. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 227-day FDA review.

K981064 · P.T. Irama Dinamika Latex · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1998
Decision
227d
Days
Class 1
Risk

K981064 is an FDA 510(k) clearance for the POWDERFREE COLORED AND FLAVORED CHLOROPRENE PATIENT EXAMINATION GLOVES. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by P.T. Irama Dinamika Latex (Indonesia, ID). The FDA issued a Cleared decision on November 5, 1998 after a review of 227 days - an extended review 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: 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 P.T. Irama Dinamika Latex devices

FDA 510(k) Submission Details - K981064

510(k) Number K981064 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1998
Decision Date November 05, 1998
Days to Decision 227 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d slower than avg
Panel avg: 129d · This submission: 227d
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 778
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K981064.
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE
K983729 · Perusahaan Getah Asas Sdn. Bhd. · Dec 1998
NITRILE LATEX POWDERED EXAMINATION GLOVE
K983816 · Top Glove Sdn. Bhd. · Dec 1998
NITRILE LATEX POWDER FREE EXAMINATION GLOVE
K983825 · Top Glove Sdn. Bhd. · Dec 1998
NITRILE PATIENT EXAMINATION GLOVE
K982440 · Perusahaan Getah Asas Sdn. Bhd. · Sep 1998
NITRILE POWDERFREE EXAMINATION GLOVES
K981877 · Besglove Medicare Sdn. Bhd. · Aug 1998
POWDERFREE NITRILE EXAMINATION GLOVES (POLYMER COATED)
K981878 · Besglove Medicare Sdn. Bhd. · Aug 1998