Cleared Traditional

K002111 - RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI

K002111 is an FDA 510(k) clearance for RUBBERCARE POLYMER-COATED POWDERED LATE..., manufactured by Perusahaan Pelindung Getah (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 58-day FDA review.

K002111 · Perusahaan Pelindung Getah (M) Sdn Bhd · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
58d
Days
Class 1
Risk

K002111 is an FDA 510(k) clearance for the RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Perusahaan Pelindung Getah (M) Sdn Bhd (Sembilan Darul Khusus Malaysia, ML). The FDA issued a Cleared decision on September 8, 2000 after a review of 58 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 Perusahaan Pelindung Getah (M) Sdn Bhd devices

FDA 510(k) Submission Details - K002111

510(k) Number K002111 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2000
Decision Date September 08, 2000
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 627
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K002111.
DERMAGRIP POWDER FREE POLYMER COATED LATEX EXAMINATION GLOVE STERILE, CONTAINS 50 MICROGRAMS OR LESS OF TOTAL EXTRACTABL
K002975 · Wrp Specialty Products Sdn. Bhd. · Oct 2000
POLYMER COAT, POWDER FREE, LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K002568 · Smart Glove Corp. Sdn Bhd · Oct 2000
POWDER FREE LATEX EXAMINATION PATIENT GLOVES
K994420 · Purna Bina Sdn Bhd · Sep 2000
DERMAGRIP POWDERFREE POLYMER COATED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS)
K002579 · Wrp Specialty Products Sdn. Bhd. · Sep 2000
LATEX PATIENT EXAMINATION GLOVES POWDERED WITH PROTEIN CONTENT LABELING CLAIM
K002314 · Perusahaan Getah Asas Sdn. Bhd. · Aug 2000
NON-STERILE POWDER FREE BUBBLE-GUM SCENTED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR
K002175 · Sgmp Co., Ltd. · Jul 2000