Cleared Traditional

K101105 - POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1

K101105 is an FDA 510(k) clearance for POWDER-FREE, manufactured by Best Putra Gloves Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 204-day FDA review.

K101105 · Best Putra Gloves Sdn Bhd · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
204d
Days
Class 1
Risk

K101105 is an FDA 510(k) clearance for the POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Best Putra Gloves Sdn Bhd (Sg Choh Rawang, Selangor, MY). The FDA issued a Cleared decision on November 10, 2010 after a review of 204 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.

FDA 510(k) Submission Details - K101105

510(k) Number K101105 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2010
Decision Date November 10, 2010
Days to Decision 204 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 129d · This submission: 204d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K101105.
NON-STERILE, POWDER-FREE, BLUE LATEX EXAMINATION GLOVES, WITHOUT BUBBLE GUM OR GRAPE SCENT,W/ PROTEIN CONTENT CLAIM
K103650 · Oon Corp. Resources · Mar 2011
PATIENT EXAMINATION GLOES
K102840 · Thai Hua Holding Co., Ltd. · Feb 2011
PATIENT EXAMINATION GLOVES
K102838 · Thai Hua Holding Co., Ltd. · Feb 2011
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1
K101106 · Best Putra Gloves Sdn Bhd · Nov 2010
COMFORT RUBBER GLOVES IND.SDN.BHD.
K101917 · Comfort Rubber Gloves Industries Sdn. Bhd. · Oct 2010
POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS
K101828 · Gx Corporation Sdn Bhd · Oct 2010
K101105 · POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1
Download PDF FDA Summary Best Putra Gloves Sdn…