Cleared Traditional

K983570 - GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE

K983570 is an FDA 510(k) clearance for GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE, manufactured by Glove Seal Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K983570 · Glove Seal Sdn Bhd · General Hospital
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Jan 1999
Decision
93d
Days
Class 1
Risk

K983570 is an FDA 510(k) clearance for the GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Glove Seal Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on January 14, 1999 after a review of 93 days - within the typical 510(k) review window.

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 Glove Seal Sdn Bhd devices

FDA 510(k) Submission Details - K983570

510(k) Number K983570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date January 14, 1999
Days to Decision 93 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
36d faster than avg
Panel avg: 129d · This submission: 93d
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 485
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983570.
LOPRO SILICONISED LOW PROTEIN POWDERFREE LATEX EXAMINATION GLOVES
K982114 · M/S Midland Latex Products , Ltd. · Jan 1999
POWDER FREE LATEX EXAMINATION GLOVES
K983998 · Sri Anusham Rubber Industries Pvt., Ltd. · Jan 1999
LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
K984147 · Lovytex Sdn Bhd · Jan 1999
MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE
K983827 · Sinetimed Latex Sdn Bhd · Jan 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · Mexpo Intl., Inc. · Jan 1999
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K982897 · Pt. Maja Agung Latexindo · Dec 1998