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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 gloves see related information
Date Initiated by Firm April 10, 2006
Date Posted May 25, 2006
Recall Status1 Terminated 3 on March 07, 2007
Recall Number Z-0909-06
Recall Event ID 35247
510(K)Number K980095  K982872  
Product Classification Latex Patient Examination Glove - Product Code LYY
Product Powder 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/
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
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.
Quantity in Commerce 815 cases, 100ea per box, 10 bx per case.
Distribution Distributed throughout the following states: PA, VA, MD, NJ, DE, NY, NH, WV, AZ and FL.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LYY and Original Applicant = TG MEDICAL SDN BHD