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Safco Nitrilex Black Gloves

SAFCO DENTAL SUPPLY CO. · Model 1027972 · UDI-DI 10810063754652

LXCLZA
10
510(k) clearances
20
Adverse events
2
Recalls
12
Facilities

Description

Safco Nitrilex Black powder-free gloves x-small 200/box

Recalls

DateFirmReason
2021-06-28MY01, INC.There is an incorrect version of the needle in the introducer part of devices. The affected Lots were manufactured using needles with a needle trocar geometry which is out of speci
2005-07-22Stryker Instruments Div. of Stryker CorporationThe pressure indicated may be inaccurate, and this inaccuracy may be not detectable by the user.

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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.