Cleared Traditional

K972616 - ONCOLOGY PLUS POWDER FREE LATEX EXAMINA...

K972616 is an FDA 510(k) clearance for ONCOLOGY PLUS POWDER FREE LATEX EXAMINA..., 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 562-day FDA review.

K972616 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1999
Decision
562d
Days
Class 1
Risk

K972616 is an FDA 510(k) clearance for the ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Wembley Rubber Products (M) Sdn Bhd (Salak Tinggi, Sepang Selangor, MY). The FDA issued a Cleared decision on January 27, 1999 after a review of 562 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K972616

510(k) Number K972616 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1997
Decision Date January 27, 1999
Days to Decision 562 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
433d slower than avg
Panel avg: 129d · This submission: 562d
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 319
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K972616.
LAGLOVE BRAND POLYMER COATED LATEX EXAMINATION GLOVE (POWDER FREE)
K990268 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVE (POWDER FREE)
K990270 · La Glove (M) Sdn. Bhd. · Feb 1999
LAGLOVE BRAND LATEX EXAMINATION GLOVES (LOW PROTEIN)
K990285 · La Glove (M) Sdn. Bhd. · Feb 1999
CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
K972615 · Wembley Rubber Products (M) Sdn Bhd · Jan 1999
TEXTURED POWDER-FREE LATEX EXAM GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K983145 · Shen Wei (Usa), Inc. · Jan 1999
NON-STERILE E.P. LATEX EXAMINATION GLOVE
K982453 · Ansell Perry · Nov 1998