FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SAFESKIN
K Number: K952851
·
Decision Aug 11, 1995
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
1953
Applicant Total
24
Review Days
51
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Basic Information
- Device Name
- SAFESKIN
- K Number
- K952851
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Safeskin Corp.
- Date Received
- June 21, 1995
- Decision Date
- August 11, 1995
- Product Code
- LYY
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| LYY | Latex Patient Examination Glove | FDA class 1 | General Hospital |
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Powder Free Latex Patient Examination Glove, Black Colored, Non-sterile, with Protein Content labeling Claim (Contains 50 ug per dm2 of glove or less of Total Water Extractable Protein)
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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 |