Cleared Traditional

K022815 - MULTIPLE PATIENT EXAMINATION GLOVES POW...

K022815 is an FDA 510(k) clearance for MULTIPLE PATIENT EXAMINATION GLOVES POW..., manufactured by Pt. Smartglove Indonesia. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K022815 · Pt. Smartglove Indonesia · General Hospital
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Feb 2003
Decision
171d
Days
Class 1
Risk

K022815 is an FDA 510(k) clearance for the MULTIPLE PATIENT EXAMINATION GLOVES POWDERED LATEX. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Smartglove Indonesia (Tg Morawa-Deli Serdang Utara, ID). The FDA issued a Cleared decision on February 13, 2003 after a review of 171 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 Pt. Smartglove Indonesia devices

FDA 510(k) Submission Details - K022815

510(k) Number K022815 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 2002
Decision Date February 13, 2003
Days to Decision 171 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
42d slower than avg
Panel avg: 129d · This submission: 171d
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 383
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K022815.
LATEX EXAMINATION GLOVE,POWEDERED TYPE II, LOW MODULUS,WITH PROTEIN LABLING CLAIM
K030333 · Perusahaan Getah Asas Sdn. Bhd. · Mar 2003
NON-STERILE, POWDER-FREE, POLYMER COATED, NATURAL AND/OR VIOLET AND BLACK COLOR, LATEX EXAMINATION GLOVES WITH PROTEIN
K030164 · Yty Industry (Manjung) Sdn Bhd · Mar 2003
POWDER FREE LATEX EXAMINATION GLOVES, STERILE WITH PROTEIN CONTENT LABELING CLAIM
K030157 · Wrp Asia Pacific Sdn. Bhd. · Feb 2003
EVERGREEN NON-STERILE POWDERED NATURAL OR COLORED LATEX EXAMINATION GLOVE
K024355 · Yty Industry (Manjung) Sdn Bhd · Feb 2003
DERMAGRIP-X POWDER FREE LATEX EXAMINATION GLOVES WITH SKIN-CARE INGREDIENTS (VITAMIN A, VITAMIN B, OC-LIPOIC ACID, EUCAL
K023490 · Wrp Asia Pacific Sdn. Bhd. · Jan 2003
MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM
K024292 · Allegiance Healthcare Corp. · Jan 2003