NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR— 510(k) K990453

Substantially Equivalent

Alliance Rubber Products Sdn. Bhd.

FDA 510(k) clearance K990453 for NITRILE EXAMINATION GLOVES, POWDER FREE, GREEN COLOR, Substantially Equivalent on 1999-03-09. Applicant: Alliance Rubber Products Sdn. Bhd.. Device class: 1.

Clearance details

Applicant
Alliance Rubber Products Sdn. Bhd.
Product code
Code LZA
Device class
Class 1
Regulation
21 CFR 880.6250
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Nibong Tebal, Pulau Pinang, MY
Download summary PDFView on FDA.gov ↗

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Adverse events under product code LZA

product code LZA
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.