Cleared Traditional

K983568 - OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER

K983568 is an FDA 510(k) clearance for OSTAR D'PRO LATEX POWDERED EXAMINATION ..., manufactured by Contract Latex Dippers Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 69-day FDA review.

K983568 · Contract Latex Dippers Sdn Bhd · General Hospital
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Dec 1998
Decision
69d
Days
Class 1
Risk

K983568 is an FDA 510(k) clearance for the OSTAR D'PRO LATEX POWDERED EXAMINATION GLOVES, PROTEIN CLAIM OF 100 MCGM OR/L.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Contract Latex Dippers Sdn Bhd (Kuala Lumpur, MY). The FDA issued a Cleared decision on December 21, 1998 after a review of 69 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 Contract Latex Dippers Sdn Bhd devices

FDA 510(k) Submission Details - K983568

510(k) Number K983568 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 13, 1998
Decision Date December 21, 1998
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K983568.
POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE WITH PROTEIN CONTENT LABELLING CLAIM (50 MICROGRAMS OR LESS)
K984019 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (150 MICROGRAMS OR LESS)
K984020 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998
LATEX PATIENT EXAMINATION GLOVE, CAT. NO. 1000M POWDERED
K982901 · Vitalcare Group, Inc. · Dec 1998
LATEX POWDER FREE EXAMINATION GLOVES
K981942 · Maika Rubber Products Sdn Bhd · Dec 1998
POWDER FREE (CHLORINATED) LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K981917 · Oon Corp. Resources · Dec 1998
POLYMER-COATED, POWDER-FREE, LATEX PATIENT EXAMINATION GLOVE
K983721 · Kossan Latex Industries(M)Sdn Bhd · Dec 1998