Cleared Traditional

K891966 - ALAMTEX PATIENT EXAMINATION GLOVES (LATEX)

K891966 is an FDA 510(k) clearance for ALAMTEX PATIENT EXAMINATION GLOVES (LATEX), manufactured by Concept Rubber Products Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 107-day FDA review.

K891966 · Concept Rubber Products Sdn Bhd · General Hospital
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Jul 1989
Decision
107d
Days
Class 1
Risk

K891966 is an FDA 510(k) clearance for the ALAMTEX PATIENT EXAMINATION GLOVES (LATEX). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Concept Rubber Products Sdn Bhd (Penang, MY). The FDA issued a Cleared decision on July 14, 1989 after a review of 107 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 - K891966

510(k) Number K891966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1989
Decision Date July 14, 1989
Days to Decision 107 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 129d · This submission: 107d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891966.
THREE GUN PATIENT EXAMINATION GLOVES
K891951 · Bilwin Corp. · Jul 1989
PATIENT EXAMINATION GLOVES
K891957 · Cheng Chang Development Co., Ltd. · Jul 1989
NIC BRAND PATIENT EXAMINATION GLOVES
K891963 · Nikemark Tape Industrial Corp. · Jul 1989
PATIENT EXAMINATION GLOVES (NATURAL LATEX)
K891967 · Butex Products (M'Sia) Sdn.Bhd · Jul 1989
PATIENT EXAMINATION GLOVE (LATEX)
K892014 · Dipform Rubber Sdn. Bhd. · Jul 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892015 · China North Industries Corp. · Jul 1989
K891966 · ALAMTEX PATIENT EXAMINATION GLOVES (LATEX)
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