Cleared Traditional

K161833 - LATEX EXAMINATION GLOVE POWDER FREE

K161833 is an FDA 510(k) clearance for LATEX EXAMINATION GLOVE POWDER FREE, manufactured by Careglove Global Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 322-day FDA review.

K161833 · Careglove Global Sdn. Bhd. · General Hospital
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Optimized for regulatory review, auditing and printing
May 2017
Decision
322d
Days
Class 1
Risk

K161833 is an FDA 510(k) clearance for the LATEX EXAMINATION GLOVE POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Careglove Global Sdn. Bhd. (Seremban, MY). The FDA issued a Cleared decision on May 23, 2017 after a review of 322 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Careglove Global Sdn. Bhd. devices

FDA 510(k) Submission Details - K161833

510(k) Number K161833 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2016
Decision Date May 23, 2017
Days to Decision 322 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
193d slower than avg
Panel avg: 129d · This submission: 322d
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 270
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K161833.
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