FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
K Number: K000165
·
Decision Mar 10, 2000
Classifications
1
FEI Numbers
169
Registration Numbers
169
Same Product Code
1953
Applicant Total
22
Review Days
51
Basic Information
- Device Name
- NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K Number
- K000165
- 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
- January 19, 2000
- Decision Date
- March 10, 2000
- 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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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 |
| 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 |
| K992156 | SYNSATION STERILE POWDER FREE, POLYVINYL CHLORIDE MEDICAL EXAMINATION GLOVES | Oct 27, 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 |