Cleared Traditional

K993326 - NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM (70 MICROGRAMS OR LESS PER

K993326 is an FDA 510(k) clearance for NON-STERILE POLYMER COATED POWDER FREE ..., manufactured by Seal Polymer Industries Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K993326 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
44d
Days
Class 1
Risk

K993326 is an FDA 510(k) clearance for the NON-STERILE POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH A PROTEI.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Lahat, Ipoh, Perak, MY). The FDA issued a Cleared decision on November 17, 1999 after a review of 44 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 Seal Polymer Industries Bhd. devices

FDA 510(k) Submission Details - K993326

510(k) Number K993326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1999
Decision Date November 17, 1999
Days to Decision 44 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
85d faster than avg
Panel avg: 129d · This submission: 44d
Pathway characteristics
Predicate-based equivalence.

LYY Device Classification - Class 1, General Controls

Product Code LYY Latex Patient Examination Glove
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6250
Definition A Latex Patient Examination Glove Is A Disposable Device Made Of Natural Rubber Latex 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 - LYY Latex Patient Examination Glove

All 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K993326.
POWDER FREE GLOVES (POLYMER COATED)
K993183 · Pan-Century Rubber Products Sdn. Bhd. · Nov 1999
OMNIGRACE LATEX EXAMINATION GLOVE, POWDER-FREE
K993419 · Omnigrace , Ltd. · Nov 1999
OMNI GRACE LATEX EXAMINATION GLOVE, POWDERED, WITH PROTEIN CLAIM (100 MICROGRAMS OR LESS)
K993479 · Omnigrace (Thailand) , Ltd. · Nov 1999
POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM)
K993458 · Sri Johani Sdn. Bhd. · Nov 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES, PREPOWDERED
K993221 · Innovative Gloves Co;, Ltd. · Nov 1999
INNOVATIVE GLOVES, LATEX EXAMINATION GLOVES POWDERFREE
K993222 · Innovative Gloves Co;, Ltd. · Nov 1999