Cleared Traditional

K896881 - LATEX DENTAL & EXAMINATION GLOVES

K896881 is an FDA 510(k) clearance for LATEX DENTAL & EXAMINATION GLOVES, manufactured by American Intl. Health Industries P.R., Inc.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K896881 · American Intl. Health Industries P.R., Inc. · General Hospital
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Apr 1990
Decision
138d
Days
Class 1
Risk

K896881 is an FDA 510(k) clearance for the LATEX DENTAL & EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by American Intl. Health Industries P.R., Inc. (Canovanas, US). The FDA issued a Cleared decision on April 25, 1990 after a review of 138 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 - K896881

510(k) Number K896881 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1989
Decision Date April 25, 1990
Days to Decision 138 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
9d slower than avg
Panel avg: 129d · This submission: 138d
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 1299
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K896881.
PATIENT EXAMINATION GLOVES
K901903 · Southland Products Co., Ltd. · May 1990
LATEX PATIENT EXAMINATION GLOVES
K902017 · Taksin Rubber Industries Co., Ltd. · May 1990
LATEX PATIENT EXAMINATION GLOVES
K901750 · Haikou Latex Factory · May 1990
STERILE LATEX PATIENT EXAMINATION GLOVES
K901116 · Medi Tex, Inc. · Apr 1990
HPI POWDER FREE NON-STERILE EXAMINATION GLOVES
K901608 · Hpi, Inc. · Apr 1990
LATEX EXAMINATION GLOVES
K896752 · Aquatic Import & Export Corp. · Apr 1990
K896881 · LATEX DENTAL & EXAMINATION GLOVES
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