FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
P2 NITRILE EXAM GLOVES
K Number: K944514
·
Decision Nov 28, 1994
Classifications
1
FEI Numbers
151
Registration Numbers
151
Same Product Code
795
Applicant Total
8
Review Days
74
Basic Information
- Device Name
- P2 NITRILE EXAM GLOVES
- K Number
- K944514
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- BIOSAFETY SYSTEMS, INC.
- Date Received
- September 15, 1994
- Decision Date
- November 28, 1994
- Product Code
- LYZ
- 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 |
|---|---|---|---|
| LYZ | Vinyl Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by BIOSAFETY SYSTEMS, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K952274 | CHEMOGUARD, P2 HIRISK | Aug 29, 1995 | Substantially Equivalent |
| K944095 | P2 NITRILE EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K944142 | P2 EXAM GLOVES | Oct 28, 1994 | Substantially Equivalent |
| K921313 | AEROSTAR | Sep 11, 1992 | Substantially Equivalent |
| K904130 | CHEMO GLOVES POWDER FREE (MFG: UNION INDUSTRIAL) | Oct 10, 1990 | Substantially Equivalent |
| K901411 | CHEMOPLUS GLOVE | Jun 7, 1990 | Substantially Equivalent |
| K900368 | P2/CHEMO PLUS GLOVES | Mar 8, 1990 | Substantially Equivalent |