Cleared Traditional

K002701 - POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)

K002701 is an FDA 510(k) clearance for POWDER FREE LATEX EXAMINATION GLOVES WI..., manufactured by Alliance Rubber Products Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K002701 · Alliance Rubber Products Sdn. Bhd. · General Hospital
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Sep 2000
Decision
14d
Days
Class 1
Risk

K002701 is an FDA 510(k) clearance for the POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING .... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Alliance Rubber Products Sdn. Bhd. (Nibong Tebal, Pulau Pinang, MY). The FDA issued a Cleared decision on September 13, 2000 after a review of 14 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.

FDA 510(k) Submission Details - K002701

510(k) Number K002701 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2000
Decision Date September 13, 2000
Days to Decision 14 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
115d faster than avg
Panel avg: 129d · This submission: 14d
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 1326
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K002701.
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDERED
K000141 · Industrial Clothings, Ltd. · Sep 2000
MIDAS TOUCH LATEX EXAMINATION GLOVES-POWDER FREE
K000142 · Industrial Clothings, Ltd. · Sep 2000
BESTEX POWDER-FREE LATEX EXAM GLOVES WITH LABELING CLAIM. (50 MICROGRAMS OR LESS)
K002087 · Qingdao Bestex Rubber & Plastic Products Co., Ltd. · Sep 2000
LATEX EXAMINATION GLOVES, POWDERED, (CONTAINS 100 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM).
K002448 · Oon Corp. Resources · Sep 2000
RUBBERCARE POLYMER-COATED POWDERED LATEX EXAMINATION GLOVES/GUARDIAN POLYMER-COATED POWDERED EXAMINATION GLOVES. CONTAI
K002111 · Perusahaan Pelindung Getah (M) 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
K002701 · POWDER FREE LATEX EXAMINATION GLOVES WITH WATER EXTRACTABLE PROTEIN LABELING CLAIM. (50 MICROGRAMS OR LESS)
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