Cleared Traditional

K891245 - PATIENT EXAMINATION GLOVES (LATEX)

K891245 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (LATEX), 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 14-day FDA review.

K891245 · Terang Nusa Sdn Bhd · General Hospital
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Mar 1989
Decision
14d
Days
Class 1
Risk

K891245 is an FDA 510(k) clearance for the PATIENT EXAMINATION GLOVES (LATEX). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Terang Nusa Sdn Bhd (68100 Batu Caves Selangor, MY). The FDA issued a Cleared decision on March 22, 1989 after a review of 14 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.

FDA 510(k) Submission Details - K891245

510(k) Number K891245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1989
Decision Date March 22, 1989
Days to Decision 14 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
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 1953
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891245.
PATIENT EXAMINATION GLOVES (LATEX)
K891209 · Chung Yuan Trading Co., Ltd. · Mar 1989
SINTON LATEX EXAMINATION GLOVE
K891220 · Sinton Latex Chemical Industries Co., Ltd. · Mar 1989
PATIENT EXAMINATION GLOVES
K891232 · Supergrade Healthcare Products Sdn. Bhd. · Mar 1989
DEFEND LATEX EXAMINATION GLOVES
K891257 · Carl Parker Associates, Inc. · Mar 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891271 · Dr. Boo Co., Ltd. · Mar 1989
LATEX EXAMINATION GLOVES
K891204 · Advance Rubber, Inc. · Mar 1989
K891245 · PATIENT EXAMINATION GLOVES (LATEX)
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