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U.S. Department of Health and Human Services

Class 2 Device Recall Latex gloves

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 Class 2 Device Recall Latex glovessee related information
Date Initiated by FirmApril 10, 2006
Date PostedMay 25, 2006
Recall Status1 Terminated 3 on March 07, 2007
Recall NumberZ-0909-06
Recall Event ID 35247
510(K)NumberK982872 
Product Classification Latex Patient Examination Glove - Product Code LYY
ProductPowder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404
Code Information lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164
Recalling Firm/
Manufacturer		 Gulf South Medical Supply Inc
4345 Southpoint Blvd
Jacksonville FL 32216-8013
Manufacturer 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.
FDA Determined
Cause 2		Other
ActionThe 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.
Quantity in Commerce815 cases, 100ea per box, 10 bx per case.
DistributionDistributed throughout the following states: PA, VA, MD, NJ, DE, NY, NH, WV, AZ and FL.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LYY
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