BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE)— 510(k) K994276

Substantially Equivalent

Biopro (M) Sdn Bhd

FDA 510(k) clearance K994276 for BIOPRO, NITRILON, CORRECT TOUCH- NITRILE POWDERED EXAMINATION GLOVES (GREEN/ PURPLE), Substantially Equivalent on 2000-10-20. Applicant: Biopro (M) Sdn Bhd. Device class: 1.

Clearance details

Applicant
Biopro (M) 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
Port Klang, 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.