Cleared Traditional

K891866 - RUBBER LATEX PATIENT EXAMINATION GLOVES

K891866 is an FDA 510(k) clearance for RUBBER LATEX PATIENT EXAMINATION GLOVES, manufactured by Amsia Intl., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K891866 · Amsia Intl., Inc. · General Hospital
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Apr 1989
Decision
15d
Days
Class 1
Risk

K891866 is an FDA 510(k) clearance for the RUBBER LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Amsia Intl., Inc. (Teaneck, US). The FDA issued a Cleared decision on April 11, 1989 after a review of 15 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.

FDA 510(k) Submission Details - K891866

510(k) Number K891866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1989
Decision Date April 11, 1989
Days to Decision 15 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
114d faster than avg
Panel avg: 129d · This submission: 15d
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 K891866.
PATIENT EXAMINATION GLOVES (LATEX)
K891877 · W.A. Rubbermate Co. C/O Orient Intl. Trading, Inc. · Apr 1989
AMMEX LATEX EXAMINATION GLOVES
K891850 · Ammex Corp. · Apr 1989
SKIN ANGEL BRAND (PATIENT EXAM GLOVES - LATEX)
K891854 · Unidus Corp. · Apr 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891883 · China National Machinery & Equipment Import & Expo · Apr 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891885 · Alfaseal Sdn. Bhd. · Apr 1989
GOLD CLASS, GRANDTEX, LATEX EXAMINATION GLOVES
K891648 · Harry Panzer Intl. Corp. · Apr 1989
K891866 · RUBBER LATEX PATIENT EXAMINATION GLOVES
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