Cleared Traditional

K891813 - PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS)

K891813 is an FDA 510(k) clearance for PATIENT EXAM GLOVES (MFG. AEK RUBBER PR..., manufactured by Mulpha Intl. Trading Corp. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K891813 · Mulpha Intl. Trading Corp. Bhd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1989
Decision
148d
Days
Class 1
Risk

K891813 is an FDA 510(k) clearance for the PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Mulpha Intl. Trading Corp. Bhd. (Selangor, Malaysia, MY). The FDA issued a Cleared decision on August 18, 1989 after a review of 148 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.

FDA 510(k) Submission Details - K891813

510(k) Number K891813 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 23, 1989
Decision Date August 18, 1989
Days to Decision 148 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
19d slower than avg
Panel avg: 129d · This submission: 148d
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 1350
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891813.
NON-STERILE LATEX EXAMINATION GLOVES
K894013 · Nova Rubber Glove Industries Sdn. Bhd. · Aug 1989
LATEX EXAMINATION GLOVES
K894456 · P T Perkasa Rubber Industries · Aug 1989
LATEX EXAMINATION GLOVES
K894473 · Protech Industries Co., Ltd. · Aug 1989
LATEX EXAMINATION GLOVES
K893104 · Chuen Her Industries Co., Ltd. · Aug 1989
LATEX EXAMINATION GLOVES
K893114 · Anro Corp. Sdn Bhd · Aug 1989
HI LATEX EXAMINATION GLOVES
K893046 · Hansa Intl., Inc. · Aug 1989
K891813 · PATIENT EXAM GLOVES (MFG. AEK RUBBER PRODUCTS)
Download PDF Mulpha Intl. Trading …