PROLAX PATIENT EXAMINATION GLOVES (LATEX)— 510(k) K892026
Substantially EquivalentErgo Intl., Ent., Inc.
FDA 510(k) clearance K892026 for PROLAX PATIENT EXAMINATION GLOVES (LATEX), Substantially Equivalent on 1989-05-25. Applicant: Ergo Intl., Ent., Inc.. Device class: 1.
Clearance details
- Applicant
- Ergo Intl., Ent., 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
- North Miami Beach, FL, US
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More clearances from Ergo Intl., Ent., Inc.
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