Cleared Traditional

K900868 - STERILE LATEX EXAMINATION GLOVE

K900868 is an FDA 510(k) clearance for STERILE LATEX EXAMINATION GLOVE, manufactured by Sri Johani Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K900868 · Sri Johani Sdn. Bhd. · General Hospital
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Mar 1990
Decision
14d
Days
Class 1
Risk

K900868 is an FDA 510(k) clearance for the STERILE LATEX EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sri Johani Sdn. Bhd. (Chester, US). The FDA issued a Cleared decision on March 9, 1990 after a review of 14 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 Sri Johani Sdn. Bhd. devices

FDA 510(k) Submission Details - K900868

510(k) Number K900868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 1990
Decision Date March 09, 1990
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 265
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K900868.
PATIENT EXAMINATION GLOVES
K905550 · Medical Device Inspection Co., Inc. · Dec 1990
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · Ansell, Inc. · Aug 1990
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · Ansell, Inc. · Aug 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · Safeskin Corp. · Dec 1989