LATEX EXAMINATION GLOVES
FDA 510(k) clearance K893591 · decided 1989-09-01
Clearance details
- K-number
- K893591
- Device name
- LATEX EXAMINATION GLOVES
- Applicant
- Shanghai Medicines & Health Products Import & Expo
- Decision
- Substantially Equivalent
- Date received
- 1989-05-09
- Decision date
- 1989-09-01
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.