Cleared Traditional

K012558 - POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM OF 50 MICROGRAMS OR LESS

K012558 is an FDA 510(k) clearance for POWDER FREE LATEX PATIENT EXAMINATION G..., manufactured by Matang Mfg. Sdn. Bhd.. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 40-day FDA review.

K012558 · Matang Mfg. Sdn. Bhd. · General Hospital
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Sep 2001
Decision
40d
Days
Class 1
Risk

K012558 is an FDA 510(k) clearance for the POWDER FREE LATEX PATIENT EXAMINATION GLOVES WITH ALOE VERA AND PROTEIN CONTE.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Matang Mfg. Sdn. Bhd. (Alexandria, US). The FDA issued a Cleared decision on September 17, 2001 after a review of 40 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 Matang Mfg. Sdn. Bhd. devices

FDA 510(k) Submission Details - K012558

510(k) Number K012558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2001
Decision Date September 17, 2001
Days to Decision 40 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
89d faster than avg
Panel avg: 129d · This submission: 40d
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 632
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K012558.
NON-STERILE POWDER FREE PURPLE LATEX EXAMINATION GLOVE WITH BLUEBERRY SCENTED AND PROTEIN CONTENT CLAIM (50 MICROGRAMS O
K012857 · Sgmp Co., Ltd. · Sep 2001
POWDER-FREE LATEX EXAM GLOVES WITH CHOCOLATE SCENTING AND PROTEIN LABELING CLAIM (<50UG/G)
K012860 · Sgmp Co., Ltd. · Sep 2001
NON-STERILE POWDER FREE LATEX EXAMINATION GLOVES WITH VANILLA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
K012863 · Sgmp Co., Ltd. · Sep 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K011045 · Shen Wei (Usa), Inc. · Sep 2001
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER
K011044 · Shen Wei (Usa), Inc. · Sep 2001
BRIGHTWAY BRAND POWDER FREE LATEX EXAMINATION GLOVES, BLUE NON-STERILE, PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS) (
K011728 · Brightway Holdings Sdn. Bhd. · Jul 2001