FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFESKIN STERILE SURGEONS GLOVES
K Number: K880446
·
Decision Jun 1, 1988
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
556
Applicant Total
24
Review Days
120
Basic Information
- Device Name
- SAFESKIN STERILE SURGEONS GLOVES
- K Number
- K880446
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4460
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Applicant
- SAFESKIN CORP.
- Date Received
- February 2, 1988
- Decision Date
- June 1, 1988
- Product Code
- KGO
- Advisory Committee
- General, Plastic Surgery
- Review Advisory Committee
- HO
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KGO | Surgeon'S Gloves | FDA class 1 | General, Plastic Surgery |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KGO), ordered by most recent decision date.
Polyisoprene Surgical gloves
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green); Natural Rubber Latex (Strip&Coat)/(Strip&Pack) Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Sterile Powder Free Latex Surgical Gloves, Tested for Use with Chemotherapy Drugs
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
GAMMEX PI Hybrid Micro (340002055); GAMMEX PI Hybrid Micro (340002060); GAMMEX PI Hybrid Micro (340002065); GAMMEX PI Hybrid Micro (340002070); GAMMEX PI Hybrid Micro (340002075); GAMMEX PI Hybrid Micro (340002080); GAMMEX PI Hybrid Micro (340002085); GAMMEX PI Hybrid Micro (340002090)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
PolyIsoprene Powder Free Black Colour Radiation Attenuating Surgical Glove
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Single-Use Latex Sterile Surgical Gloves (SG100)
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
Other Clearances by SAFESKIN CORP.
| K Number | Device Name | ||
|---|---|---|---|
| K993117 | SAFESKIN PFE-XTRA POWDER-FREE LATEX EXAMINATION GLOVES, PROTEIN CONTENT 50 MCG OR LESS, FOR USE WITH CHEMOTHERAPEUTIC AG | Mar 2, 2000 | Substantially Equivalent |
| K994081 | SAFESKIN TACTYLON PF POWDER-FREE SURGEON'S GLOVES | Jan 18, 2000 | Substantially Equivalent |
| K992830 | SAFESKIN POLYMER-COATED NITRILE EXAMINATION GLOVES, POWDER-FREE SHIELDMASTER NITRILE GLOVE | Oct 27, 1999 | Substantially Equivalent |
| K992210 | SHIELDMASTER POWDERED PURPLE NITRILE EXAMINATION GLOVES | Sep 10, 1999 | Substantially Equivalent |
| K992162 | SAFESKIN PURPLE POWDER-FREE NITRILE EXAMINATION GLOVES FOR USE WITH CHEMOTHERAPEUTIC DRUGS LABELING CLAIM | Aug 30, 1999 | Substantially Equivalent |
| K992062 | SAFESKIN STERILE PURPLE NITRILE EXAMINATION GLOVES | Aug 25, 1999 | Substantially Equivalent |
| K991951 | SAFESKIN SYNTHETIC BINYO POWDER-FREE POLYMER COATED EXAMINATION GLOVES (GREEN, WHITE) | Jul 26, 1999 | Substantially Equivalent |
| K991317 | POWDER-FREE LATEX SURGEON'S GLOVE SAFESKIN PFS PLUS CONTAINS 50MLGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | May 21, 1999 | Substantially Equivalent |
| K970899 | SAFESKIN POWDERED EXAMINATION GLOVE | May 6, 1997 | Substantially Equivalent |
| K962139 | SAFESKIN | Dec 19, 1996 | Substantially Equivalent |