Cleared Traditional

K891702 - PATIENT EXAMINATION GLOVES (LATEX)

K891702 is an FDA 510(k) clearance for PATIENT EXAMINATION GLOVES (LATEX), manufactured by Thai Nam Rubber Gloves Co., Ltd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K891702 · Thai Nam Rubber Gloves Co., Ltd. · General Hospital
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Jun 1989
Decision
91d
Days
Class 1
Risk

K891702 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 Thai Nam Rubber Gloves Co., Ltd. (Chicago, US). The FDA issued a Cleared decision on June 19, 1989 after a review of 91 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.

View all Thai Nam Rubber Gloves Co., Ltd. devices

FDA 510(k) Submission Details - K891702

510(k) Number K891702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1989
Decision Date June 19, 1989
Days to Decision 91 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 129d · This submission: 91d
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 732
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K891702.
PATIENT EXAMINATION GLOVES (LATEX)
K892750 · Baxter Healthcare Corp · Jul 1989
PATIENT EXAMINATION GLOVES (DENTAL)
K892751 · Baxter Healthcare Corp · Jul 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892289 · Ansell, Inc. · Jun 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892288 · Ansell, Inc. · Jun 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892104 · Hartalega Sdn Bhd · May 1989
STERILE EXAM GLOVES
K892106 · Ansell, Inc. · May 1989