Cleared Traditional

K952197 - GLOVETEX (MULTIPLE)

K952197 is an FDA 510(k) clearance for GLOVETEX (MULTIPLE), manufactured by Pt Mbf Buana Multicorpora. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 97-day FDA review.

K952197 · Pt Mbf Buana Multicorpora · General Hospital
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Aug 1995
Decision
97d
Days
Class 1
Risk

K952197 is an FDA 510(k) clearance for the GLOVETEX (MULTIPLE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Mbf Buana Multicorpora (Medan, ID). The FDA issued a Cleared decision on August 14, 1995 after a review of 97 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 Pt Mbf Buana Multicorpora devices

FDA 510(k) Submission Details - K952197

510(k) Number K952197 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1995
Decision Date August 14, 1995
Days to Decision 97 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 129d · This submission: 97d
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 446
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K952197.
HYPOALLERGENIC POWDERED AMBIDEXTROUS COAGULATN DIPPED LATEX EXAMINATION GLOVE
K953379 · Ansell, Inc. · Sep 1995
ROYAL SHIELD NON-STERILE POWDER-FREE HYPOALLERGENIC LATEX EXAMINATION GLOVES
K953496 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1995
LATEX PATIENT EXAMINATION GLOVE POWDERFREE LAMINATED COPOLYMER
K951018 · Siam Sempermed Corp., Ltd. · Aug 1995
ROYAL SHIELD PINK & BLUE COLORED NON-STERILE LATEX EXAMINATION GLOVES
K952589 · Shield Gloves Manufacturer (M) Sdn Bhd · Aug 1995
SAFESKIN
K952793 · Safeskin Corp. · Aug 1995
SAFESKIN
K952851 · Safeskin Corp. · Aug 1995