Cleared Traditional

K003547 - NUGARD DG POWDERED GREEN-MINT LATEX EXA...

K003547 is an FDA 510(k) clearance for NUGARD DG POWDERED GREEN-MINT LATEX EXA..., manufactured by Terang Nusa Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K003547 · Terang Nusa Sdn Bhd · General Hospital
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Dec 2000
Decision
34d
Days
Class 1
Risk

K003547 is an FDA 510(k) clearance for the NUGARD DG POWDERED GREEN-MINT LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT L.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (Kota Bharu, MY). The FDA issued a Cleared decision on December 21, 2000 after a review of 34 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 Terang Nusa Sdn Bhd devices

FDA 510(k) Submission Details - K003547

510(k) Number K003547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 17, 2000
Decision Date December 21, 2000
Days to Decision 34 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 129d · This submission: 34d
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 264
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K003547.
MEDLINE STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K003055 · Medline Industries, Inc. · Jan 2001
STERILE POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVES, WITH PROTEIN LABELING CLAIM (50 MICROGRAM OR LESS)
K003653 · Wrp Asia Pacific Sdn. Bhd. · Jan 2001
NUGARD POWDERFREE, BLUE POLYMER COATED LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LE
K003545 · Terang Nusa Sdn Bhd · Dec 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
K002175 · Sgmp Co., Ltd. · Jul 2000