Safeskin Corp.
Coral Gables, FL, US
Safeskin Corp. appears in FDA device records in Coral Gables, FL. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Safeskin Corp. between 1988 and 2000. The busiest year on record is 1989, with 7. The most recent is 2000, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1988 | 1 |
| 1989 | 7 |
| 1994 | 2 |
| 1995 | 4 |
| 1996 | 1 |
| 1997 | 1 |
| 1999 | 6 |
| 2000 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K993117 | SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG | LYY | Substantially Equivalent | |
| K994081 | SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES | KGO | Substantially Equivalent | |
| K992830 | SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE | LZA | Substantially Equivalent | |
| K992210 | SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | LZC | Substantially Equivalent | |
| K992062 | SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES | LZA | Substantially Equivalent | |
| K991951 | SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) | LYZ | Substantially Equivalent | |
| K991317 | POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | KGO | Substantially Equivalent | |
| K970899 | SAFESKIN POWDERED EXAMINATION GLOVE | LYY | Substantially Equivalent | |
| K962139 | SAFESKIN | LZA | Substantially Equivalent | |
| K953015 | SAFESKIN SUPRA | KGO | Substantially Equivalent | |
| K952993 | SAFESKIN SUPRA | KGO | Substantially Equivalent | |
| K952851 | SAFESKIN | LYY | Substantially Equivalent | |
| K952793 | SAFESKIN | LYY | Substantially Equivalent | |
| K932405 | NITRILE RUBBER EXAMINATION GLOVES (POWERED) | FMC | Substantially Equivalent | |
| K932404 | NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE | FMC | Substantially Equivalent | |
| K895807 | STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC' | LYY | Substantially Equivalent | |
| K894497 | LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.) | LYY | Substantially Equivalent | |
| K895669 | POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES | KGO | Substantially Equivalent | |
| K894354 | SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES | KGO | Substantially Equivalent | |
| K894311 | MODIFIED PATIENT EXAMINATION GLOVES | LYY | Substantially Equivalent | |
| K891435 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | |
| K891264 | PATIENT EXAMINATION GLOVES (LATEX) | LYY | Substantially Equivalent | |
| K880446 | SAFESKIN STERILE SURGEONS GLOVES | KGO | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain