Ssl Americas, Inc.
Norcross, GA, US
Ssl Americas, Inc. appears in FDA device records in Norcross, GA. FDA records list 16 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show one recall for this company.
FDA records held for this company
510(k) clearance history
FDA records hold 16 510(k) clearances for Ssl Americas, Inc. between 2002 and 2008. The busiest year on record is 2004, with 4. The most recent is 2008, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 2 |
| 2004 | 4 |
| 2005 | 4 |
| 2006 | 2 |
| 2008 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K072169 | DUREX SYNTHETIC POLYISOPRENE MALE CONDOM | MOL | Substantially Equivalent | |
| K072236 | DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT | NUC | Substantially Equivalent | |
| K071626 | DUREX PLAY SOFT & SENSUAL LUBRICANT | NUC | Substantially Equivalent | |
| K063385 | DUREX PLAY MASSAGE GEL LUBRICANT | NUC | Substantially Equivalent | |
| K060098 | DUREX PLAY TEMPTATIONS ASSORTED LUBRICANTS | NUC | Substantially Equivalent | |
| K052959 | DUREX MALE COLORED LATEX CONDOMS WITH SCENTED LUBRICANTS | HIS | Substantially Equivalent | |
| K042958 | DUREX PLAY TINGLING LUBRICANT | NUC | Substantially Equivalent | |
| K042470 | DUREX SPEARMINT SCENTED LUBRICATED LATEX CONDOM (DUREX 'TINGLING PLEASURE' CONDOM | HIS | Substantially Equivalent | |
| K042563 | DUREX PLAY WARMER LUBRICANT | KMJ | Substantially Equivalent | |
| K042957 | DUREX MALE LATEX CONDOM WITH WARMING LUBRICANT | HIS | Substantially Equivalent | |
| K040185 | DUREX STUDDED/RIBBED LUBRICATED LATEX CONDOM | HIS | Substantially Equivalent | |
| K032227 | DUREX FLAVORED LATEX CONDOM | HIS | Substantially Equivalent | |
| K040353 | FLIGHT SOCK | DWL | Substantially Equivalent | |
| K032124 | DUREX PLAY LUBRICANT | HIS | Substantially Equivalent | |
| K020308 | REGENT BIOGEL SKINSENSE STERILE POWDER-FREE, SYNTHETIC POLYISOPRENE SURGEON'S GLOVE | KGO | Substantially Equivalent | |
| K020659 | DUREX LATEX CONDOM WITH MALE GENITAL DESENSITIZER LUBRICANT | HIS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0346-03 | 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. | Sulfur particles on the surface of gloves. | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain