Cleared Traditional

K031754 - FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE

K031754 is an FDA 510(k) clearance for FLEXISKIN POWDER FREE LATEX EXAMINATION..., manufactured by Pt. Mandiri Inti Buana. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K031754 · Pt. Mandiri Inti Buana · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
91d
Days
Class 1
Risk

K031754 is an FDA 510(k) clearance for the FLEXISKIN POWDER FREE LATEX EXAMINATION GLOVES, NON STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt. Mandiri Inti Buana (Medan, ID). The FDA issued a Cleared decision on June 30, 2003 after a review of 91 days - within the typical 510(k) review window.

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. Mandiri Inti Buana devices

FDA 510(k) Submission Details - K031754

510(k) Number K031754 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2003
Decision Date June 30, 2003
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 600
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K031754.
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINES 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACE
K030583 · Shen Wei (Usa), Inc. · Nov 2003
NON-STERILE, POWDER FREE GREEN LATEX EXAMINATION GLOVES WITH OR WITHOUT SOUR APPLE OR PEPPERMINT SCENTING PLUS A PROTEIN
K032293 · Sgmp Co., Ltd. · Aug 2003
NON-STERILE, POWDER FREE ORANGE LATEX EXAMINATION GLOVES W/ OR WITHOUT ORANGE/VANILLA SCENTING PLUS A PROTEIN LABELING
K032294 · Sgmp Co., Ltd. · Aug 2003
POWDER-FREE LATEX PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), OR BLUE COLORED, WITH EXTRACTABLE PROTEIN CONTENT LABE
K031414 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
CHLORINATED, POLYMER COATED, POWDER-FREE LATEX EXAMINATION GLOVE
K031021 · Perusahaan Getah Asas Sdn. Bhd. · Jun 2003
NON-STERILE POWDERED GREEN COLORED POWDERED LATEX PATIENT EXAMINATION GLOVES WITH & WITHOUT SOUR/APPLE/PEPPERMINT SCENTS
K030993 · Sgmp Co., Ltd. · Jun 2003