Cleared Traditional

K915607 - PATIENT EXAMINATION GLOVES

K915607 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES, 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 444-day FDA review.

K915607 · Seal Polymer Industries Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1993
Decision
444d
Days
Class 1
Risk

K915607 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Seal Polymer Industries Bhd. (Jaya Selangor W. Malaysia, MY). The FDA issued a Cleared decision on March 4, 1993 after a review of 444 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Seal Polymer Industries Bhd. devices

FDA 510(k) Submission Details - K915607

510(k) Number K915607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1991
Decision Date March 04, 1993
Days to Decision 444 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
315d slower than avg
Panel avg: 129d · This submission: 444d
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 583
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K915607.
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993
SOLACE POWDER FREE LATEX EXAMINATION GLOVES
K922551 · Wembley Rubber Products (M) Sdn Bhd · May 1993
ANSELL NO POWDER AMBI PATIENT EXAMINATION GLOVES
K913766 · Ansell, Inc. · Mar 1993
LATEX PATIENT EXAMINATION GLOVE (POWDER FREE)
K923862 · Siam Sempermed Corp., Ltd. · Feb 1993
COMFIT STERILE LATEX EXAMINATION GLOVE
K922513 · Wembley Rubber Products (M) Sdn Bhd · Aug 1992
AUDIOTONE MODEL A97
K920092 · Miracle-Ear, Inc. · Jan 1992