Cleared Traditional

K993529 - POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)

K993529 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Biografik (Malaysia) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K993529 · Biografik (Malaysia) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
72d
Days
Class 1
Risk

K993529 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES, POLYMER COATED WITH PROTEIN CONTENT LAB.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Biografik (Malaysia) Sdn Bhd (Nilai, Negeri Sembilan, MY). The FDA issued a Cleared decision on December 29, 1999 after a review of 72 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 Biografik (Malaysia) Sdn Bhd devices

FDA 510(k) Submission Details - K993529

510(k) Number K993529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1999
Decision Date December 29, 1999
Days to Decision 72 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
57d faster than avg
Panel avg: 129d · This submission: 72d
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 K993529.
INNOVATIVE GLOVES LATEX EXAMINATION GLOVES POWDERFREE WITH PROTEIN LABELING CLAIM [50 MICROGRAMS OR LESS]
K993567 · Innovative Gloves Co;, Ltd. · Jan 2000
GUTHRIE PRIME PRE-POWDERED PATIENT LATEX EXAMINATION GLOVE
K993793 · Guthrie Medicare Products (Melaka) Sdn Bhd · Jan 2000
CORRECT TOUCH LATEX POWDERED EXAMINATION GLOVES
K994043 · Biopro (M) Sdn Bhd · Jan 2000
HEALTH-PLUS, SANITEX, RELIANCE, BLUE PRE-POWDERED LATEX EXAMINATION GLOVES, WITH PROTEIN CONTENT LABELING CLAIM (100 MIC
K993621 · Pamitex Industries Sdn Bhd · Dec 1999
LATEX EXAMINATION POWDERED GLOVES
K993386 · Great Glove Sdn Bhd · Dec 1999
GREEN POWDERED LATEX EXAMINATION GLOVES
K993452 · Top Glove Sdn. Bhd. · Dec 1999