Cleared Traditional

K153744 - A1 Glove Powder Free Latex Patient Exam...

K153744 is an FDA 510(k) clearance for A1 Glove Powder Free Latex Patient Exam..., manufactured by A1 Glove Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 220-day FDA review.

K153744 · A1 Glove Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2016
Decision
220d
Days
Class 1
Risk

K153744 is an FDA 510(k) clearance for the A1 Glove Powder Free Latex Patient Examination Gloves with Protein Content La.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by A1 Glove Sdn Bhd (Nilai, MY). The FDA issued a Cleared decision on August 4, 2016 after a review of 220 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 A1 Glove Sdn Bhd devices

FDA 510(k) Submission Details - K153744

510(k) Number K153744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2015
Decision Date August 04, 2016
Days to Decision 220 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
91d slower than avg
Panel avg: 129d · This submission: 220d
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 347
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K153744.
POWDER FREE LATEX EXAMINATION GLOVE
K173053 · Professional Latex Sdn Bhd · Jun 2018
SANCARE STERILE LATEX EXAMINATION GLOVES (also marketed as GLOVTEK STERILE LATEX EXAMINATION GLOVES)
K171367 · Sanrea Healthcare Products Pvt, Ltd. · Jan 2018
Nugard Black Powder Free Latex Examination Glove, Polymer Coated, Contains 50 Micrograms or less of water extractable protein
K170779 · Terang Nusa Sdn Bhd · May 2017
Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
K161006 · Hartalega Sdn Bhd · Aug 2016
Patient Examination Gloves
K143419 · Hartalega NGC Sdn. Bhd. · Mar 2015
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT DRUG WITH PROTEIN LABELING CLAIM OF 50 M
K133953 · Hartalega Sdn Bhd · May 2014