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FDA Medical Device Recalls (openFDA)

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

Recall number
Z-0909-06
Recalling firm
Gulf South Medical Supply Inc
Product
Powder Free Latex , Non-sterile Medical Exam Gloves Cat #s: 22401 22402 22403 and 22404
Status
Terminated
Initiated
2006-04-10
Posted
2006-05-25
Terminated
2007-03-07
Reason
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.
Root cause
Other
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
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.
Lot, serial or model codes
lot/unit numbers: 04000130161, 04000130162, 04000160163, 04000130164
510(k) numbers
["K982872"]
PMA numbers
not on file
Product code
LYY
Firm FEI
3003119579
Firm city
Jacksonville
Firm state
FL
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

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Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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