ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE— 510(k) K981392
Substantially EquivalentAnsell Perry
FDA 510(k) clearance K981392 for ELITE MARK IV POWDER FREE POLYURETHANE SYNTHETIC SURGICAL GLOVE, Substantially Equivalent on 1998-05-11. Applicant: Ansell Perry. Device class: 1.
Clearance details
- Applicant
- Ansell Perry
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Massillon, OH, US
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More clearances from Ansell Perry
view all- K003895 — X-TENDA CUFF POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM 50 MICROGRAMS OR LESS, MODEL STYLE 21
- K002192 — DERMAGUARD PF BROWN POWDER FREE LATEX SURGICAL GLOVES; MODEL STYLE 38
- K001239 — ENCORE POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
- K000165 — NEXT STEP POWDER FREE LATEX EXAMINATION GLOVES CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER GRAM
- K000295 — ENCORE MICROPTIC POWDER FREE LATEX SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)
Data sourced from openFDA. This site is unofficial and independent of the FDA.