STERILE SURGEONS' GLOVES
FDA 510(k) clearance K891621 · decided 1989-04-20
Clearance details
- K-number
- K891621
- Device name
- STERILE SURGEONS' GLOVES
- Applicant
- Albors-Menconi Latex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-03-17
- Decision date
- 1989-04-20
- Days to decision
- 34 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
- San Juan, Puerto Rico, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.