MAUDE report

MAUDE report 12116: LATEX EXAMINATION GLOVES (POWDER FREE)

No Answer Provided · received Mar 18, 1994 · SAFESKIN CORP.

Key facts

MDR report key 12116
Report number MW1001150
Event type No Answer Provided
Brand name LATEX EXAMINATION GLOVES (POWDER FREE)
Manufacturer SAFESKIN CORP.
Product code LYY
Device class Class I
PMA or 510(k) number Device Exempt
Date received by FDA Mar 18, 1994
Report date Mar 14, 1994
Report source Maude

At a glance

  • None Device problems coded
  • 1,000+ MAUDE reports for this product code
  • 1–9 MAUDE reports for this brand
  • None Death reports for this brand
  • None Injury reports for this brand
  • No Adverse event flagged
  • Yes Product problem flagged

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE medical device reports

MAUDE holds medical device reports (MDRs) of suspected device-associated deaths, serious injuries and malfunctions submitted to the FDA by manufacturers, importers, user facilities and the public. A report alone does not establish that a device caused an event.

Source: U.S. Food and Drug Administration (FDA), MAUDE (Manufacturer and User Facility Device Experience) database · Source date:

Browse all MAUDE medical device reports