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.

View all Shun Thai Rubber Gloves Industry Co., Ltd. devices

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 480
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K930139.
COMFIT
K933263 · Wembley Rubber Products (M) Sdn Bhd · Feb 1994
COMFIT GREEN POWDER FREE EXAMINATION GLOVE
K934812 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
COMFIT BLUE POWDER FREE EXAMINATION GLOVE
K934813 · Wembley Rubber Products (M) Sdn Bhd · Jan 1994
POWDERFREE NATURAL LATEX GLOVES
K921389 · Arista Latindo Industrial Ltd. P.T · Aug 1993
DIGITEX, DIGITEX HYPOALLERGENIC
K926049 · Mayer Laboratories · Jul 1993
NON-STERILE LATEX EXAMINATION GLOVES(PRE-POWDERED)
K925683 · Arista Latindo Industrial Ltd. P.T · Jun 1993