Z-0346-03

Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a...

Name: Z-0346-03 Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a...
Creator: SSL Americas Inc.
Published: 2002-11-25
License: https://open.fda.gov/license/

Ssl Americas, Inc. / initiated 2002-11-25 / Terminated

FDA source

SSL Americas Inc. began a recall of Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia... on 2002-11-25. The reason FDA records is "Sulfur particles on the surface of gloves". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0346-03
Status: Terminated
Initiated: 2002-11-25
Posted: 2002-12-18
Terminated: 2003-07-21
Recalling firm: Ssl Americas, Inc.
Product: Biogel Skinsense N, Non-Latex, Powder-free Surgical Gloves with Biogel coating, Neoprene, Made from a synthetic Elastomer, Sterile/R, REGENT, Made in Malaysia, Regent Medical, Norcross, GA USA 30092, 1-800-843-8497, Toft Hall, Knotsford, Cheshire WA16 9PD, TEL: +44 (0) 1565 624000, Regent Medical is a Member of SSL International plc. Lot Number 01H0161 through 01H2668, sizes: 7-7 , One Pair sterile gloves packaged 50 pair per box/ 4 boxes per case/ total 200 pair per case.
Product code: KGO Surgeon'S Gloves
Reason for recall: Sulfur particles on the surface of gloves.
FDA root cause: Other
Action: On 11/25/2002 the Company representatives contacted the headquarter offices of the firm's in the U.S. by telephone and in writing by UPS delivery. On 11/26/2002 the Company sent the distributors' branches letters via UPS delivery. Approximately 1500 hospitals (customers of the Company's distributors) were notified by letter via UPS delivery. Customers were instructed to cease distribution of the suspected lot number gloves, contact their customers, and return any remaining gloves via UPS to the recalling firm. A response letter is attached to the recall letter. The Company intends to contact by telephone all of its direct accounts who do not respond to the Recall Letter.
Quantity in commerce: 173,310 pairs
Distribution: Various Hospitals, Direct accounts,and Company sales representatives in: AL, AZ,, CA, CO, CT, FL, GA, IL, IN, KY, LA, MA, MD, MI, MO, MN, MT, NC, ND, NE, NJ, NM, NY, OH, OK, OR, PA, RI, SD, TN, TX, VA, VT, WA, WI. Foreign Accounts in: Canada, Venezuela and British Colombia. SSL Canada, Concord, Canada; Corporacion Alivari, Caracas, Venezuela; and Wilhelmina Martin, Port Moody, British Colombia. No government accounts involved.
Product codes and lots: Lot numbers 01H0161 through 01H2668

Product code KGO

K000421Class IBiogel Neotech II Powder-Free Neoprene Surgeon's GloveSsl Americas, Inc. (Regent Medical) / cleared 2000-08-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)