DISPOSABLE POWDERED VINYL EXAM GLOVES— 510(k) K031134
Substantially EquivalentElite International, Inc.
FDA 510(k) clearance K031134 for DISPOSABLE POWDERED VINYL EXAM GLOVES, Substantially Equivalent on 2003-05-20. Applicant: Elite International, Inc.. Device class: 1.
Clearance details
- Applicant
- Elite International, Inc.
- Product code
- Code LYZ
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rowland Heights, CA, US
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