Cleared Traditional

K895021 - MEDICARE GLOVES

K895021 is an FDA 510(k) clearance for MEDICARE GLOVES, manufactured by Shangrila Latex Industries Pvt. , Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 189-day FDA review.

K895021 · Shangrila Latex Industries Pvt. , Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1990
Decision
189d
Days
Class 1
Risk

K895021 is an FDA 510(k) clearance for the MEDICARE GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shangrila Latex Industries Pvt. , Ltd. (Bombay 400 026, IN). The FDA issued a Cleared decision on February 13, 1990 after a review of 189 days - an extended review 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: 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.

View all Shangrila Latex Industries Pvt. , Ltd. devices

FDA 510(k) Submission Details - K895021

510(k) Number K895021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date February 13, 1990
Days to Decision 189 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
60d slower than avg
Panel avg: 129d · This submission: 189d
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 K895021.
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
POWDER-FREE VINYL EXAMINATION GLOVES
K894686 · Dynarex Corp. · Jan 1990
CLP ELEVATED LIPID CONTROL
K895858 · Creative Laboratory Products, Inc. · Jan 1990
ANSELL DENTA GLOVES
K895660 · Ansell, Inc. · Jan 1990