Cleared Traditional

K922551 - SOLACE POWDER FREE LATEX EXAMINATION GLOVES

K922551 is an FDA 510(k) clearance for SOLACE POWDER FREE LATEX EXAMINATION GLOVES, manufactured by Wembley Rubber Products (M) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 347-day FDA review.

K922551 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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May 1993
Decision
347d
Days
Class 1
Risk

K922551 is an FDA 510(k) clearance for the SOLACE POWDER FREE LATEX EXAMINATION GLOVES. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Kuala Lumpur, Malaysia, MY). The FDA issued a Cleared decision on May 11, 1993 after a review of 347 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K922551

510(k) Number K922551 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1992
Decision Date May 11, 1993
Days to Decision 347 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
218d slower than avg
Panel avg: 129d · This submission: 347d
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 910
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K922551.
THE BODYGUARDS ULTRA POW-FREE HYPO LATEX EXAM GLOV
K924909 · T.K. Glove Products Co., Ltd. · May 1993
LATEX EXAMINATION GLOVES
K922439 · Transcorp · May 1993
POWDER-FREE LATEX EXAMINATION GLOVES
K925537 · Safetytech Sdn. Bhd. · May 1993
DERMATOUCH PLUS HYPOALLERGENIC EXAMINATION GLOVES
K925358 · Colonial Surgical Supply, Inc. · Apr 1993
DOCTOR'S CHOICE LATEX EXAMINATION GLOVES
K924265 · Chesire Laboratories · Mar 1993
SAVACARE LATEX EXAMINATION GLOVES
K924233 · Preventive Care, Inc. · Mar 1993