Cleared Traditional

K951171 - SCIPOTEX

K951171 is an FDA 510(k) clearance for SCIPOTEX, 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 29-day FDA review.

K951171 · Wembley Rubber Products (M) Sdn Bhd · General Hospital
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Apr 1995
Decision
29d
Days
Class 1
Risk

K951171 is an FDA 510(k) clearance for the SCIPOTEX. 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 April 13, 1995 after a review of 29 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Wembley Rubber Products (M) Sdn Bhd devices

FDA 510(k) Submission Details - K951171

510(k) Number K951171 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 15, 1995
Decision Date April 13, 1995
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
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 K951171.
COMFIT
K951468 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
COMFIT PINK POWDERED EXAMINATION GLOVES (HYPOALLERGENIC)
K936266 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
COMFIT FPOWDER FREE EXAMINATION GLOVERS (HYPOALLERGENIC)
K951137 · Wembley Rubber Products (M) Sdn Bhd · Apr 1995
CYPRESS MEDICAL PRODUCTS STERILE LATEX EXAMINATION GLOVE
K950254 · Cypress Medical Products, Ltd. · Mar 1995
PATIENT EXAMINATION GLOVES
K945885 · Hartalega Sdn Bhd · Mar 1995
COMFIT BLUE POWDER FREE EXAMINATION GLOVES
K943563 · Wembley Rubber Products (M) Sdn Bhd · Mar 1995