Cleared Traditional

K900811 - LATEX PATIENT EXAMINATION GLOVES

K900811 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVES, manufactured by Kenwell International , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K900811 · Kenwell International , Ltd. · General Hospital
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Mar 1990
Decision
16d
Days
Class 1
Risk

K900811 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Kenwell International , Ltd. (Karnataka, Karnataka, IN). The FDA issued a Cleared decision on March 9, 1990 after a review of 16 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 Kenwell International , Ltd. devices

FDA 510(k) Submission Details - K900811

510(k) Number K900811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1990
Decision Date March 09, 1990
Days to Decision 16 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
113d faster than avg
Panel avg: 129d · This submission: 16d
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 K900811.
MODIFIED NON-STERILE LATEX EXAMINATION GLOVES
K902181 · Aladan Corp. · Jun 1990
MODIFIED STERILE LATEX EXAMINATION GLOVES
K902182 · Aladan Corp. · Jun 1990
DESERET MULTILUMEN SUBCLAVIAN CATHETER
K895735 · Deseret Medical, Inc. · May 1990
STERILE LATEX EXAMINATION GLOVE
K900868 · Sri Johani Sdn. Bhd. · Mar 1990
NON-STERILE LATEX PROCEDURE GLOVE
K900869 · Sri Johani Sdn. Bhd. · Mar 1990
UMI BRAIDED CATHETER CONNECTOR
K897128 · Universal Medical Instrument Corp. · Mar 1990