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Terminated

Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404

FDA Recall Z-0909-06 · Posted 2006-05-25

Recalling FirmGulf South Medical Supply Inc
Recall StatusTerminated
Product CodeLYY
Date Initiated2006-04-10
Date Terminated2007-03-07
Product Quantity815 cases, 100ea per box, 10 bx per case.

Reason for Recall

FDA'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 allow hazardous substances to come into contact with the user's skin.

Firm Action

The recall is being conducted to the user level. All consignees will be notified by US postal Service letter dated April 10, 2006, first class mail, followed by a phone call. They will be instructed to check their inventory for the lot number of the recalled gloves. Customers who have the product on hand should call the firm at 904-332-4141 to make arrangement for pick up and replacement of the product.

Root Cause

Other

Distribution Pattern

Distributed throughout the following states: PA, VA, MD, NJ, DE, NY, NH, WV, AZ and FL.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K982872TG MEDICAL POWDER-FREE LATEX EXAMINATION GLOVE PROTEIN LABELING CLAIM (50 MICROGRAMS OR LESS)Tg Medical Sdn. Bhd. · 1998-10-15

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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