Cleared Traditional

K993271 - QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM OF 170 MICROGRAM OR LESS

K993271 is an FDA 510(k) clearance for QUALITY LATEX POWDERED LATEX MEDICAL GL..., manufactured by Quality Latex Corp. Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K993271 · Quality Latex Corp. Sdn Bhd · General Hospital
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Dec 1999
Decision
63d
Days
Class 1
Risk

K993271 is an FDA 510(k) clearance for the QUALITY LATEX POWDERED LATEX MEDICAL GLOVES WITH PROTEIN CONTENT LABELING CLA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Quality Latex Corp. Sdn Bhd (Ipoh, Perak, MY). The FDA issued a Cleared decision on December 2, 1999 after a review of 63 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 Quality Latex Corp. Sdn Bhd devices

FDA 510(k) Submission Details - K993271

510(k) Number K993271 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 30, 1999
Decision Date December 02, 1999
Days to Decision 63 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
66d faster than avg
Panel avg: 129d · This submission: 63d
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 K993271.
PATIENT LATEX EXAMINATION GLOVE POWDERED & POWDER FREE, STERILE
K992681 · Wear Safe Malaysia Sdn. Bhd. · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL CLAIM - 50 MICROGRAMS OR LESS)
K993454 · Sri Johani Sdn. Bhd. · Dec 1999
GLOVCO, POWDER-FREE CHLORINATED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)
K993752 · Glovco (M) Sdn. Bhd. · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (PROTEIN LABEL CLAIM) [50 MICROGRAMS OR LESS]
K993457 · Sri Johani Sdn. Bhd. · Dec 1999
POWDERFREE LATEX EXAMINATION GLOVES (POLYMER COATED) (PROTEIN LABEL OF 50 MCROGRAM OR LESS)
K993500 · Besglove Medicare Sdn. Bhd. · Dec 1999
POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE WITH PROTEIN LABELING CLAIM 50 MICROGRAM OR LESS
K993820 · Felda Rubber Corp. · Dec 1999