Cleared Traditional

K032010 - GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE

K032010 is an FDA 510(k) clearance for GLOVETEX POWDER FREE NITRILE EXAMINATIO..., manufactured by Pt. Wrp Buana Multicorpora. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K032010 · Pt. Wrp Buana Multicorpora · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
50d
Days
Class 1
Risk

K032010 is an FDA 510(k) clearance for the GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE. Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Pt. Wrp Buana Multicorpora (Medan, ID). The FDA issued a Cleared decision on August 19, 2003 after a review of 50 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.

FDA 510(k) Submission Details - K032010

510(k) Number K032010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2003
Decision Date August 19, 2003
Days to Decision 50 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 129d · This submission: 50d
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 1180
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K032010.
POWDER-FREE NITRILE EXAMINATION GLOVES, BLUE COLOR (TESTED FOR USE WITH CHEMOTHERAPY DRUGS)
K032024 · Shen Wei (Usa), Inc. · Oct 2003
VINYL EXAMINATION GLOVES, POWDER FREE AND PINK COLOR
K031944 · Arista Latindo Industrial Ltd. P.T · Sep 2003
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K032549 · Matang Mfg. Sdn. Bhd. · Sep 2003
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011 · Pt. Wrp Buana Multicorpora · Aug 2003
CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
K032077 · Seal Polymer Industries Bhd. · Aug 2003
POWDER-FREE NITRILE EXAMINATION GLOVE (BLUE) WITH NATURAL WATER SOLUBLE VITAMIN E AND ALOE VERA, PEPPERMINT SCENTED
K031157 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Aug 2003
K032010 · GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
Download PDF FDA Summary Pt. Wrp Buana Multico…