LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS— 510(k) K011749
Substantially EquivalentSempermed USA, Inc.
FDA 510(k) clearance K011749 for LATEX POWDERED PATIENT EXAMINATION GLOVE, 200 MICROGRAMS OR LESS, Substantially Equivalent on 2001-08-22. Applicant: Sempermed USA, Inc.. Device class: 1.
Clearance details
- Applicant
- Sempermed USA, Inc.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Harbor, FL, US
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