Cleared Traditional

K891640 - PATIENT EXAMINATION GLOVES (LATEX)(POWD...

K891640 is the FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (LATEX)(POWD... by Perusahaan Getah Asas Sdn. Bhd.. It is a Class 1 General Hospital device (product code LYY) cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K891640 · Perusahaan Getah Asas Sdn. Bhd. · General Hospital
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May 1989
Decision
66d
Days
Class 1
Risk

K891640 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (LATEX)(POWDERED). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Getah Asas Sdn. Bhd. (42000 Port Kelang, S.D.E., MY). The FDA issued a Cleared decision on May 22, 1989 after a review of 66 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 Perusahaan Getah Asas Sdn. Bhd. devices

Submission Details

510(k) Number K891640 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date May 22, 1989
Days to Decision 66 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
63d faster than avg
Panel avg: 129d · This submission: 66d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 150
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891640.
PATIENT EXAMINATION GLOVES (DENTAL)
K892751 · Baxter Healthcare Corp · Jul 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892104 · Hartalega Sdn Bhd · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892742 · Shen Wei (Usa), Inc. · May 1989
CURITY DISPOSABLE LATEX GLOVES
K891255 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1989