Cleared Traditional

K980916 - POWDER-FREE LATEX EXAMINATION GLOVES WI...

K980916 is the FDA 510(k) clearance for POWDER-FREE LATEX EXAMINATION GLOVES WI... by Perusahaan Getah Asas Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K980916 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
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Aug 1998
Decision
160d
Days
Class 1
Risk

K980916 is an FDA 510(k) clearance for the POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (Selangor, Darul Ehsan, MY). The FDA issued a Cleared decision on August 18, 1998 after a review of 160 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 Perusahaan Getah Asas Sdn. Bhd. devices

Submission Details

510(k) Number K980916 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1998
Decision Date August 18, 1998
Days to Decision 160 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
31d slower than avg
Panel avg: 129d · This submission: 160d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K980916.
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145 · Shen Wei (Usa), Inc. · Jan 1999
LATEX PATIENT EXAMINATION GLOVE POWDERFREE (BLUE COLOR) POLYMER COATED
K981975 · Siam Sempermed Corp., Ltd. · Nov 1998
POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (GREEN)
K980572 · Hartalega Sdn Bhd · Mar 1998
POWDER-FREE LATEX EXAMINATION GLOVES (BLUE)
K980318 · Hartalega Sdn Bhd · Mar 1998
POLYMER COATED POWDER-FREE LATEX EXAMINATION GLOVES
K973778 · Hartalega Sdn Bhd · Dec 1997