FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
K Number: K021452
·
Decision Aug 1, 2002
Classifications
1
FEI Numbers
380
Registration Numbers
380
Same Product Code
1171
Applicant Total
26
Review Days
87
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Basic Information
- Device Name
- STERILE SENSICARE ADVANTIX POWDER FREE POLYURETHANE MEDICAL/DENTAL EXAMINATION GLOVE
- K Number
- K021452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Maxxim Medical
- Date Received
- May 6, 2002
- Decision Date
- August 1, 2002
- Product Code
- LZA
- 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 |
|---|---|---|---|
| LZA | Polymer Patient Examination Glove | FDA class 1 | General Hospital |
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Other Clearances by Maxxim Medical
| K Number | Device Name | ||
|---|---|---|---|
| K023236 | SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Nov 12, 2002 | Substantially Equivalent |
| K011905 | SNIPER ELITE MODEL-OR-E3872XX SERIES | Aug 28, 2001 | Substantially Equivalent |
| K002847 | INTRODUCER WITH DISTAL RADIOPAQUE MARKER BAND, MODEL OR-4926XX | May 31, 2001 | Substantially Equivalent |
| K010297 | SENSICARE SYNTHETIC POWDER FREE SURGICAL GLOVES (POLY ISOPRENE) | Feb 16, 2001 | Substantially Equivalent |
| K002933 | STERILE SENSICARE SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES | Oct 19, 2000 | Substantially Equivalent |
| K990173 | PATHFINDER II ANGIOGRAPHIC CATHETER | Dec 21, 1999 | Substantially Equivalent |
| K992865 | SENSICARE XP VINYL POWDER FREE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent |
| K991615 | POLYURETHANE POWDER FREE DENTAL EXAMINATION GLOVE, POLYURETHANE POWDER FREE MEDICAL EXAMINATION GLOVE | Jul 30, 1999 | Substantially Equivalent |
| K992122 | TRU-TOUCH PF VINYL POWDER FREE EXAMINATION GLOVE | Jul 15, 1999 | Substantially Equivalent |
| K984189 | ARGON MULTI-LUMEN CENTRAL VENOUS CATHETER | May 5, 1999 | Substantially Equivalent |