Cleared Traditional

K894979 - LATEX PATIENT EXAMINATION GLOVES

K894979 is an FDA 510(k) clearance for LATEX PATIENT EXAMINATION GLOVES, manufactured by Tower Rubber Industries Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K894979 · Tower Rubber Industries Sdn. Bhd. · General Hospital
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Sep 1989
Decision
35d
Days
Class 1
Risk

K894979 is an FDA 510(k) clearance for the LATEX PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Tower Rubber Industries Sdn. Bhd. (Selat Klang Utara, Port Klang, MY). The FDA issued a Cleared decision on September 12, 1989 after a review of 35 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 - K894979

510(k) Number K894979 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1989
Decision Date September 12, 1989
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 1363
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K894979.
LATEX EXAMINATION GLOVES
K893235 · Quingdao Latex Factory · Sep 1989
LATEX EXAMINATION GLOVES
K893339 · Kenmark Industrial Co., Ltd. · Sep 1989
UNICARE LATEX EXAMINATION GLOVES
K894972 · Pt. Indorub Nusaraya · Sep 1989
LATEX PATIENT EXAMINATION GLOVES
K894995 · Orient Commercial Co., Ltd. · Sep 1989
STERILE PATIENT EXAMINATION GLOVES (LATEX)
K893095 · Asia Way Trading, Inc. · Sep 1989
GLOBE PATIENT EXAMINATION GLOVES
K893159 · Lucky and Happy, Inc. · Sep 1989
K894979 · LATEX PATIENT EXAMINATION GLOVES
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