Cleared Traditional

K961675 - BG PATIENT EXAMINATION GLOVES, NON-STERILE

K961675 is an FDA 510(k) clearance for BG PATIENT EXAMINATION GLOVES, manufactured by Biografik (Malaysia) Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K961675 · Biografik (Malaysia) Sdn Bhd · General Hospital
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Jul 1996
Decision
90d
Days
Class 1
Risk

K961675 is an FDA 510(k) clearance for the BG PATIENT EXAMINATION GLOVES, NON-STERILE. Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Biografik (Malaysia) Sdn Bhd (Nilai, Negeri Sembilan, MY). The FDA issued a Cleared decision on July 25, 1996 after a review of 90 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.

View all Biografik (Malaysia) Sdn Bhd devices

FDA 510(k) Submission Details - K961675

510(k) Number K961675 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1996
Decision Date July 25, 1996
Days to Decision 90 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
39d faster than avg
Panel avg: 129d · This submission: 90d
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 582
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K961675.
PATIENT EXAMINATION GLOVE (POWDERED)
K954293 · Medline Products Co. , Ltd. · Jul 1996
COMFIT POWDER FREE BLUE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962188 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT POWDER FREE GREEN EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN)
K962189 · Wembley Rubber Products (M) Sdn Bhd · Jul 1996
COMFIT
K953590 · Wembley Rubber Products (M) Sdn Bhd · Jun 1996
SINOCHEM NINGBO LATEX EXAMINATION GLOVE, POWDER FREE
K955918 · Sinochem Ningbo Imp & Exp Corp. · Jun 1996
HANDSAFE
K960386 · Handsafe Products Sdn. Bhd. · Jun 1996