Cleared Traditional

K032077 - CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)

K032077 is an FDA 510(k) clearance for CASHMERE NON-STERILE, manufactured by Seal Polymer Industries Bhd.. The device is a Class 1 General Hospital device with product code LZA cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K032077 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2003
Decision
43d
Days
Class 1
Risk

K032077 is an FDA 510(k) clearance for the CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET). Classified as Polymer Patient Examination Glove (product code LZA), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Lahat, Perak, MY). The FDA issued a Cleared decision on August 19, 2003 after a review of 43 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 - K032077

510(k) Number K032077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 07, 2003
Decision Date August 19, 2003
Days to Decision 43 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
86d faster than avg
Panel avg: 129d · This submission: 43d
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 1177
Devices cleared under the same product code (LZA) and FDA review panel - the closest regulatory comparables to K032077.
MATANG POWDER-FREE POLYCHLOROPRENE PATIENT EXAMINATION GLOVES
K032549 · Matang Mfg. Sdn. Bhd. · Sep 2003
GLOVETEX POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, NON-STERILE
K032010 · Pt. Wrp Buana Multicorpora · Aug 2003
GLOVETEX POWDER FREE WHITE NITRILE EXAMINATION GLOVES, NON-STERILE
K032011 · Pt. Wrp Buana Multicorpora · 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
LEGEND (BRAND) NITRILE POWDER-FREE PATIENT EXAMINATION GLOVE
K030529 · Jda (Tianjin) Plastic Rubber Co., Ltd. · Aug 2003
POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED
K031625 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2003
K032077 · CASHMERE NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES (VIOLET)
Download PDF FDA Summary Seal Polymer Industri…