FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
K Number: K992156
·
Decision Oct 27, 1999
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
798
Applicant Total
22
Review Days
124
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Basic Information
- Device Name
- SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES
- K Number
- K992156
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 880.6250
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ansell Perry
- Date Received
- June 25, 1999
- Decision Date
- October 27, 1999
- 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 Ansell Perry
| K Number | Device Name | ||
|---|---|---|---|
| K003895 | X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21 | Jan 17, 2001 | Substantially Equivalent |
| K002192 | DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38 | Jul 27, 2000 | Substantially Equivalent |
| K001239 | ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | May 15, 2000 | Substantially Equivalent |
| K000165 | NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM | Mar 10, 2000 | Substantially Equivalent |
| K000295 | ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) | Feb 16, 2000 | Substantially Equivalent |
| K993857 | THE ORIGINAL PERRY, STYLE 42 WHITE LATEX POWDERED SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (60 MICROGRAMS OR | Jan 31, 2000 | Substantially Equivalent |
| K992953 | SURGEONS GLOVE, BROWN LATEX POLYMER COATED, POWDER FREE WITH PROTEIN LABEL CLAIM | Oct 29, 1999 | Substantially Equivalent |
| K992768 | NITRA-TOUCH STERILE POWDER-FREE NITRILE MEDICAL EXAMINATION GLOVE | Oct 13, 1999 | Substantially Equivalent |
| K984559 | ELITE POWDER-FREE POLYURETHANE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | Feb 26, 1999 | Substantially Equivalent |
| K984558 | DERMA PRENE POWDER-FREE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) | Feb 26, 1999 | Substantially Equivalent |