Medical Device Manufacturer · US , Coral Gables , FL

Safeskin Corp. - FDA 510(k) Cleared Devices

24 submissions · 24 cleared · Since 1988
24
Total
24
Cleared
0
Denied

FDA 510(k) Regulatory Record - Safeskin Corp. General Hospital

24 devices
1-24 of 24
Cleared Mar 02, 2000
SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50...
K993117 · LYY
General Hospital · 164d
Cleared Jan 18, 2000
SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES
K994081 · KGO
General Hospital · 46d
Cleared Oct 27, 1999
SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER...
K992830 · LZA
General Hospital · 65d
Cleared Sep 10, 1999
SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES
K992210 · LZA
General Hospital · 71d
Cleared Aug 30, 1999
SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH...
K992162 · LZC
General Hospital · 66d
Cleared Aug 25, 1999
SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES
K992062 · LZA
General Hospital · 68d
Cleared Jul 26, 1999
SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES...
K991951 · LYZ
General Hospital · 46d
Cleared May 21, 1999
POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS...
K991317 · KGO
General Hospital · 32d
Cleared May 06, 1997
SAFESKIN POWDERED EXAMINATION GLOVE
K970899 · LYY
General Hospital · 56d
Cleared Dec 19, 1996
SAFESKIN
K962139 · LZA
General Hospital · 199d
Cleared Aug 28, 1995
SAFESKIN SUPRA
K952993 · KGO
General Hospital · 61d
Cleared Aug 28, 1995
SAFESKIN SUPRA
K953015 · KGO
General Hospital · 60d
Cleared Aug 11, 1995
SAFESKIN
K952793 · LYY
General Hospital · 53d
Cleared Aug 11, 1995
SAFESKIN
K952851 · LYY
General Hospital · 51d
Cleared May 18, 1994
NITRILE RUBBER POWDER-FREE EXAMINATION GLOVE
K932404 · FMC
General Hospital · 370d
Cleared May 18, 1994
NITRILE RUBBER EXAMINATION GLOVES (POWERED)
K932405 · FMC
General Hospital · 370d
Cleared Dec 18, 1989
STERILE EXAMINATION GLOVES, HYPO-ALLERGENIC'
K895807 · LYY
General Hospital · 80d
Cleared Nov 16, 1989
LATEX EXAMINATION GLOVES (POWDER-FREE/HYPO-ALLER.)
K894497 · LYY
General Hospital · 125d
Cleared Nov 03, 1989
POWDER-FREE/HYPO-ALLERGENIC STERILE SURGEON GLOVES
K895669 · KGO
General Hospital · 45d
Cleared Aug 23, 1989
SAFESKIN POWDRED HYPOALLERGENIC STERIL SURG GLOVES
K894354 · KGO
General Hospital · 40d
Cleared Aug 10, 1989
MODIFIED PATIENT EXAMINATION GLOVES
K894311 · LYY
General Hospital · 27d
Cleared May 12, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891435 · LYY
General Hospital · 58d
Cleared Apr 13, 1989
PATIENT EXAMINATION GLOVES (LATEX)
K891264 · LYY
General Hospital · 36d
Cleared Jun 01, 1988
SAFESKIN STERILE SURGEONS GLOVES
K880446 · KGO
General Hospital · 120d
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