Cleared Traditional

K100611 - RS CARE LATEX MEDICAL EXAMINATION GLOVE...

K100611 is an FDA 510(k) clearance for RS CARE LATEX MEDICAL EXAMINATION GLOVE..., manufactured by Riverstone Resources Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K100611 · Riverstone Resources Sdn Bhd · General Hospital
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Jul 2010
Decision
135d
Days
Class 1
Risk

K100611 is an FDA 510(k) clearance for the RS CARE LATEX MEDICAL EXAMINATION GLOVE (POWDER FREE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Riverstone Resources Sdn Bhd (Selangor, MY). The FDA issued a Cleared decision on July 16, 2010 after a review of 135 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 Riverstone Resources Sdn Bhd devices

FDA 510(k) Submission Details - K100611

510(k) Number K100611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2010
Decision Date July 16, 2010
Days to Decision 135 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
6d slower than avg
Panel avg: 129d · This submission: 135d
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 269
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K100611.
LATEX POWDER FREE EXAMINATION GLOVES WITH COLLOIDAL OATMEAL USP SKIN PROTECTANT
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NON-STERILE, POWER FREE YELLOW LATEX EXAMINATION GLOVES
K112693 · Sgmp Co., Ltd. · Sep 2012
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K103602 · Medline Industries, Inc. · Apr 2011
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K100907 · Siam Sempermed Corp., Ltd. · Jul 2010
LA GLOVE BRAND COLORED LATEX EXAMINATION GLOVES, POWDER FREE, NON STERILE (PINK/ GREEN/ VIOLET)
K093193 · La Glove (M) Sdn. Bhd. · Jun 2010
PEARLSCENT BLACK TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES, COATED WITH ALOE VERA
K100211 · Shen Wei (Usa), Inc. · May 2010