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U.S. Department of Health and Human Services

Class 2 Device Recall

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  Class 2 Device Recall see related information
Date Initiated by Firm July 23, 2002
Date Posted March 12, 2003
Recall Status1 Terminated 3 on January 24, 2005
Recall Number Z-0635-03
Recall Event ID 25611
510(K)Number K945164  
Product Classification Latex Patient Examination Glove - Product Code LYY
Product Latex examination gloves, Uniseal brand.
Code Information Lot numbers: 41991221 41991223 41001105 41001120 41010428 41010530 41010613 41010618
Recalling Firm/
American Healthcare Products Inc
3260 Industry Drive
Signal Hill CA 90806-4014
For Additional Information Contact Tony Dije
Manufacturer Reason
for Recall
Unfit for intended use due to stickiness.
FDA Determined
Cause 2
Action Firm sent recall letter 7/23/2002.
Quantity in Commerce 6121 cases
Distribution Nationwide.
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 = PROTECTION GLOVES SDN. BHD.