Cleared Traditional

K991474 - HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NATURAL LATEX LAMINATED WITH NITRILE, EXTERNA

K991474 is an FDA 510(k) clearance for HEALTH-PLUS, manufactured by Pamitex Industries Sdn Bhd. The device is a Class 1 General Hospital device with product code LYY cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K991474 · Pamitex Industries Sdn Bhd · General Hospital
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Optimized for regulatory review, auditing and printing
Oct 1999
Decision
162d
Days
Class 1
Risk

K991474 is an FDA 510(k) clearance for the HEALTH-PLUS, SANITEX, RELIANCE, PRE-POWDERED MULTI-PLY EXAMINATION GLOVE, (NA.... Classified as Latex Patient Examination Glove (product code LYY), Class I - General Controls.

Submitted by Pamitex Industries Sdn Bhd (Seremban, N.S., MY). The FDA issued a Cleared decision on October 6, 1999 after a review of 162 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Pamitex Industries Sdn Bhd devices

FDA 510(k) Submission Details - K991474

510(k) Number K991474 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1999
Decision Date October 06, 1999
Days to Decision 162 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
33d slower than avg
Panel avg: 129d · This submission: 162d
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 813
Devices cleared under the same product code (LYY) and FDA review panel - the closest regulatory comparables to K991474.
AMBIDERM LATEX EXAMINATION GLOVES (VIOLET, BLUE , GREEN, AND PINK) CONTAINING 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE
K993080 · Medtexx Partners, Inc. · Oct 1999
HEALTH-PLUS SANITEX,RELIANCE PRE-POWDERED MULTI-PLY LATEX EXAMINATION GLOVE (NATURAL RUBBER LATEX-NITRILE-CONSTRUCTION W
K992523 · Pamitex Industries Sdn Bhd · Oct 1999
POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES LABELING CONTENT: 100 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEI
K992870 · Alliance Rubber Products Sdn. Bhd. · Oct 1999
PRE-POWDERED LATEX EXAMINATION GLOVE WITH OAT-STARCH POWDER
K992117 · Pamitex Industries Sdn Bhd · Sep 1999
HWA (AND) SILKTEX POWDER-FREE LATEX EXAMINATION GLOVE
K992810 · Hwa Teh Industrial Sdn. Bhd. · Sep 1999
EXTRA-CARE LATEX PATIENT EXAMINATION GLOVE, POWDER-FREE, POLYMER COATED
K992175 · Ultrawin Sdn Bhd · Sep 1999