Cleared Traditional

K891556 - EXAM GLOVES (VINYL) MFG. GLORIOUS WEALT...

K891556 is an FDA 510(k) clearance for EXAM GLOVES (VINYL) MFG. GLORIOUS WEALT..., manufactured by Green Light Import Export Co., Inc.. The device is a Class 1 Ear, Nose, Throat device with product code ESD cleared through the Traditional 510(k) pathway after a 397-day FDA review.

K891556 · Green Light Import Export Co., Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1990
Decision
397d
Days
Class 1
Risk

K891556 is an FDA 510(k) clearance for the EXAM GLOVES (VINYL) MFG. GLORIOUS WEALTH CO.. Classified as Hearing Aid, Air-conduction, Prescription (product code ESD), Class I - General Controls.

Submitted by Green Light Import Export Co., Inc. (Pompano Beach, US). The FDA issued a Cleared decision on April 18, 1990 after a review of 397 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3300 - the FDA ear, nose and throat 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Green Light Import Export Co., Inc. devices

FDA 510(k) Submission Details - K891556

510(k) Number K891556 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1989
Decision Date April 18, 1990
Days to Decision 397 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
308d slower than avg
Panel avg: 89d · This submission: 397d
Pathway characteristics
Predicate-based equivalence.

ESD Device Classification - Class 1, General Controls

Product Code ESD Hearing Aid, Air-conduction, Prescription
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3300
Definition An Air-conduction Hearing Aid Is A Wearable Sound Amplifying Device Intended To Compensate For Impaired Hearing That Conducts Sound To The Ear Through The Air. This Is A Prescription Hearing Aid.
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 - ESD Hearing Aid, Air-conduction, Prescription

All 740
Devices cleared under the same product code (ESD) and FDA review panel - the closest regulatory comparables to K891556.
SIEMENS MODEL 284 PP
K893576 · Siemens Hearing Instruments, Inc. · May 1990
SEARS MODEL 9094 ITE HEARING AID
K901350 · Miracle-Ear, Inc. · Apr 1990
SEARS MODEL 9098 ITE HEARING AID
K901351 · Miracle-Ear, Inc. · Apr 1990
AUDIOTONE MODEL FFI ITE HEARING AID
K901556 · Miracle-Ear, Inc. · Apr 1990
BTE HEARING AID, UNITRON MODELS US80PP AND US80PPL
K901569 · Unitron Industries, Inc. · Apr 1990
SEARS MODEL LI9097 IN-THE-EAR HEARING INSTRUMENT
K901387 · Miracle-Ear, Inc. · Apr 1990