Cleared Traditional

K891123 - RUBBERCARE PATIENT EXAMINATION GLOVE

K891123 is an FDA 510(k) clearance for RUBBERCARE PATIENT EXAMINATION GLOVE, manufactured by Perusahaan Pelindung Getah (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 134-day FDA review.

K891123 · Perusahaan Pelindung Getah (M) Sdn Bhd · General Hospital
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Jul 1989
Decision
134d
Days
Class 1
Risk

K891123 is an FDA 510(k) clearance for the RUBBERCARE PATIENT EXAMINATION GLOVE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Pelindung Getah (M) Sdn Bhd (Seremban, N.S., MY). The FDA issued a Cleared decision on July 14, 1989 after a review of 134 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K891123

510(k) Number K891123 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1989
Decision Date July 14, 1989
Days to Decision 134 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
5d slower than avg
Panel avg: 129d · This submission: 134d
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 K891123.
NR LATEX EXAMINATION GLOVES
K891010 · Universal Bodycare (I) Sdn. Bhd. · Jul 1989
SHIELD BRAND (PATIENT EXAMINATION GLOVE)
K891102 · Poly Shield Industries (Malaysia) Sdn. Bhd. · Jul 1989
LATEX PATIENT EXAMINATION GLOVES
K891110 · I Horng Industrial Co., Ltd. · Jul 1989
PATIENT EXAMINATION GLOVE (LATEX)
K891134 · Grupo Industrial Supertex S.A. DE C.V. · Jul 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891174 · Howard Associates, Inc. · Jul 1989
PATIENT EXAMINATION GLOVES
K891284 · Real Latex Pvt. , Ltd. · Jul 1989
K891123 · RUBBERCARE PATIENT EXAMINATION GLOVE
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