Cleared Traditional

K910045 - PATIENT EXAMINATION GLOVES-POWDER FREED

K910045 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES-POWDER FREED, manufactured by Pan-Century Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K910045 · Pan-Century Rubber Products Sdn. Bhd. · General Hospital
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Jan 1991
Decision
11d
Days
Class 1
Risk

K910045 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES-POWDER FREED. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pan-Century Rubber Products Sdn. Bhd. (81700 Johor, Malaysia, ML). The FDA issued a Cleared decision on January 15, 1991 after a review of 11 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 Pan-Century Rubber Products Sdn. Bhd. devices

FDA 510(k) Submission Details - K910045

510(k) Number K910045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1991
Decision Date January 15, 1991
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
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 583
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K910045.
LATEX PATIENT EXAMINATION GLOVES
K911081 · Medical Device Inspection Co., Inc. · Mar 1991
ALADERM
K905678 · Aladan Corp. · Jan 1991
PATIENT EXAMINATION GLOVES
K905551 · Johnson & Johnson Medical, Inc. · Jan 1991
PATIENT EXAMINATION GLOVES
K905550 · Medical Device Inspection Co., Inc. · Dec 1990
PATIENT EXAM GLOVES (DUSTED W/USP STARCH POWDER)
K903107 · Ansell, Inc. · Aug 1990
PATIENT EXAM GLOVES (FINISH W/USP STARCH POWDER)
K903108 · Ansell, Inc. · Aug 1990