Cleared Traditional

K992358 - CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE)

K992358 is an FDA 510(k) clearance for CORRECT TOUCH POWDER FREE 911 LATEX EXA..., manufactured by Biopro (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.

K992358 · Biopro (M) Sdn Bhd · General Hospital
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Sep 1999
Decision
58d
Days
Class 1
Risk

K992358 is an FDA 510(k) clearance for the CORRECT TOUCH POWDER FREE 911 LATEX EXAMINATION GLOVES, (BLUE). Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Biopro (M) Sdn Bhd (Port Klang, MY). The FDA issued a Cleared decision on September 10, 1999 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 Biopro (M) Sdn Bhd devices

FDA 510(k) Submission Details - K992358

510(k) Number K992358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1999
Decision Date September 10, 1999
Days to Decision 58 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
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 487
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K992358.
ROYAL SHIELD NON-STERILE POWDERED LATEX EXAMINATION GLOVES (PROTEIN LABELING CLAIM) 200 MCGM OR LESS OF TOTAL WATER EXTR
K992417 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
ROYAL SHIELD NON-STERILE PINK COLORED POWDERED LATEX EXAMINATION GLOVE WITH AND WITHOUT STRAWBERRY SCENT AND WITH PROTEI
K992418 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
ROYAL SHIELD NON-STERILE BLUE COLORED POWDERED LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (200 MCGM OR
K992419 · Shield Gloves Manufacturer (M) Sdn Bhd · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (137 MCG OR LESS)
K991969 · Pamitex Industries Sdn Bhd · Sep 1999
HEALTH-PLUS, SANITEX, RELIANCE POWDER-FREE LATEX EXAMINATION GLOVE
K992165 · Pamitex Industries Sdn Bhd · Aug 1999
TEXTURED POWDER-FREE LATEX EXAMINATION GLOVES WITH ALOE VERA GREEN, CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
K992200 · Shen Wei (Usa), Inc. · Aug 1999