Cleared Traditional

K983827 - MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE

K983827 is an FDA 510(k) clearance for MAXIKLEEN-LATEX EXAMINATION GLOVE POWDE..., manufactured by Sinetimed Latex Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K983827 · Sinetimed Latex Sdn Bhd · General Hospital
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Jan 1999
Decision
76d
Days
Class 1
Risk

K983827 is an FDA 510(k) clearance for the MAXIKLEEN-LATEX EXAMINATION GLOVE POWDER FREE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Sinetimed Latex Sdn Bhd (Taiping, Perak, MY). The FDA issued a Cleared decision on January 14, 1999 after a review of 76 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sinetimed Latex Sdn Bhd devices

FDA 510(k) Submission Details - K983827

510(k) Number K983827 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 30, 1998
Decision Date January 14, 1999
Days to Decision 76 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 129d · This submission: 76d
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 485
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983827.
POWDER FREE LATEX EXAMINATION GLOVES
K983998 · Sri Anusham Rubber Industries Pvt., Ltd. · Jan 1999
LOVYTEX SND BHD POWDER-FREE POLYMER COATED LATEX EXAMINATION GLOVES
K984147 · Lovytex Sdn Bhd · Jan 1999
GLOVE SEAL D'PRO LATEX EXAMINATION GLOVE
K983570 · Glove Seal Sdn Bhd · Jan 1999
BLOSSOM POWDERED LATEX EXAMINATION GLOVES
K984040 · Mexpo Intl., Inc. · Jan 1999
POWDER FREE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K982897 · Pt. Maja Agung Latexindo · Dec 1998
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
K984019 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998