FDA Device Intelligence
HomeDynarex Corporation › SafeTouch Black Arrow Gloves, Small, Latex Examination Gloves, Powder Free

SafeTouch Black Arrow Gloves, Small, Latex Examination Gloves, Powder Free

Dynarex Corporation · Model 2321 · UDI-DI 00616784232126

LYY
10
510(k) clearances
2,992
Adverse events (17 deaths)
6
Recalls
150
Facilities

Description

Ambidextrous

Recalls

DateFirmReason
2020-08-19Ansell Healthcare Products LLCExamination gloves were shipped inadvertently, without to verify barrier integrity.
2011-12-22Adenna IncThe recall was initiated because Adenna Inc. distributed latex gloves that have been FDA refused.
2006-04-10Gulf South Medical Supply IncFDA's laboratory analysis found holes in the gloves that exceeded the allowable limit. Gloves with holes compromise the integrity of the latex barrier and have the potential to all
2003-06-27Henry Schein, Inc.FDA's analysis revealed defects (holes) in the latex gloves.
2003-06-27Henry Schein, Inc.FDA's analysis revealed defects (holes) in the latex gloves.
2002-07-23American Healthcare Products IncUnfit for intended use due to stickiness.

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.