Cleared Traditional

K031625 - POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED

K031625 is an FDA 510(k) clearance for POWDER-FREE BARRIER-PRO CO-POLYMER EXAM..., manufactured by Perusahaan Getah Asas Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K031625 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
66d
Days
Class 1
Risk

K031625 is an FDA 510(k) clearance for the POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AN.... Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Gambrills, US). The FDA issued a Cleared decision on August 1, 2003 after a review of 66 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 Perusahaan Getah Asas Sdn. Bhd. devices

FDA 510(k) Submission Details - K031625

510(k) Number K031625 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date August 01, 2003
Days to Decision 66 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 129d · This submission: 66d
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 1012
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K031625.
SMART-FEEL POWDER FREE NITRILE EXAMINATION GLOVES PINK COLOR
K033683 · Smart Glove Corp. Sdn Bhd · Jan 2004
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
BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
K031768 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED
K031591 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G
K031384 · Yty Industry (Manjung) Sdn Bhd · Jun 2003