Cleared Traditional

K930139 - HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES

K930139 is an FDA 510(k) clearance for HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES, manufactured by Shun Thai Rubber Gloves Industry Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 224-day FDA review.

K930139 · Shun Thai Rubber Gloves Industry Co., Ltd. · General Hospital
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Aug 1993
Decision
224d
Days
Class 1
Risk

K930139 is an FDA 510(k) clearance for the HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Shun Thai Rubber Gloves Industry Co., Ltd. (Thailand, TH). The FDA issued a Cleared decision on August 24, 1993 after a review of 224 days - an extended review 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: 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 - K930139

510(k) Number K930139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1993
Decision Date August 24, 1993
Days to Decision 224 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d slower than avg
Panel avg: 129d · This submission: 224d
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 1362
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K930139.
POWDER-FREE LATEX EXAMINATION GLOVES
K930407 · Influx Pacific Sdn. Bhd. · Aug 1993
PROBE PERSONAL PREFERENCE NON-STER. PAT. EXAM.GLOV
K930903 · Glove India Private , Ltd. · Aug 1993
LATEX EXAMINATION GLOVES (POWDER FREE)
K926526 · Rantran, Inc. · Aug 1993
POWDERED EXAMINATION GLOVES
K930995 · P.T. Healthcare Glovindo · Aug 1993
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
PATIENT EXAMINATION GLOVE
K924556 · Cenland Industries Sdn Bhd · Aug 1993
K930139 · HYPO-ALLERGENIC PATIENT EXAMINATION GLOVES
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