REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE
FDA 510(k) clearance K951908 · decided 1995-09-01
Clearance details
- K-number
- K951908
- Device name
- REGENT BIOGEL LATEX-FREE SURGEON'S GLOVE
- Applicant
- Regent Hospital Products
- Decision
- Substantially Equivalent
- Date received
- 1995-04-24
- Decision date
- 1995-09-01
- Days to decision
- 130 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.