Cleared Traditional

K891728 - LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD)

K891728 is an FDA 510(k) clearance for LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD), manufactured by Baldur Systems Corp.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K891728 · Baldur Systems Corp. · General Hospital
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May 1989
Decision
63d
Days
Class 1
Risk

K891728 is an FDA 510(k) clearance for the LATEX EXAM GLOVES (MFG. KOON SENG SDN BHD). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Baldur Systems Corp. (Hayward, US). The FDA issued a Cleared decision on May 25, 1989 after a review of 63 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 Baldur Systems Corp. devices

FDA 510(k) Submission Details - K891728

510(k) Number K891728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1989
Decision Date May 25, 1989
Days to Decision 63 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 129d · This submission: 63d
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 498
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891728.
PATIENT EXAMINATION GLOVES (LATEX)
K892104 · Hartalega Sdn Bhd · May 1989
STERILE EXAM GLOVES
K892106 · Ansell, Inc. · May 1989
NON-STERILE EXAM GLOVES
K892325 · Ansell, Inc. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891736 · Quest Intl., Inc. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892742 · Shen Wei (Usa), Inc. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)(POWDERED)
K891640 · Perusahaan Getah Asas Sdn. Bhd. · May 1989