Cleared Traditional

K892115 - PROTEX PATIENT EXAMINATION GLOVES (LATEX)

K892115 is an FDA 510(k) clearance for PROTEX PATIENT EXAMINATION GLOVES (LATEX), manufactured by Pt Nusa Dipa Perdana. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K892115 · Pt Nusa Dipa Perdana · General Hospital
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Apr 1989
Decision
21d
Days
Class 1
Risk

K892115 is an FDA 510(k) clearance for the PROTEX PATIENT EXAMINATION GLOVES (LATEX). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pt Nusa Dipa Perdana (Great Neck, US). The FDA issued a Cleared decision on April 25, 1989 after a review of 21 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 Pt Nusa Dipa Perdana devices

FDA 510(k) Submission Details - K892115

510(k) Number K892115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1989
Decision Date April 25, 1989
Days to Decision 21 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 129d · This submission: 21d
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 739
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K892115.
PATIENT EXAMINATION GLOVES (LATEX)
K891435 · Safeskin Corp. · May 1989
PATIENT EXAMINATION GLOVES (LATEX)
K892086 · Cypress Medical Products, Ltd. · May 1989
NON-STERILE LATEX EXAMINATION GLOVES
K891441 · Arista Latindo Industrial Ltd. P.T · Apr 1989
CURITY DISPOSABLE LATEX GLOVES
K891255 · Kendall Healthcare Products Co. Div.Of Tyco Health · Apr 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891264 · Safeskin Corp. · Apr 1989
LATEX EXAMINATION GLOVES NON-STERILE
K890356 · Quest Intl., Inc. · Apr 1989