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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namepowder, dusting, surgical
Generic Namepowder, dusting, surgical
Regulation Number878.4480
10 finderne avenue
suite c
bridgewater, NJ 08807
PMA NumberN80535
Supplement NumberS009
Date Received03/19/1999
Decision Date07/16/1999
Product Code
Advisory Committee General Hospital
Supplement Typenormal 180 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for revised labeling. The request to replace the warning statement: "warning-the powder should be washed off gloves with sterile solution before treated gloves are used in surgery," with the statement: "caution: after donning, remove powder by wiping gloves thoroughly with a sterile wet sponge, sterile wet towel, or other effective method," is acceptable.