SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
FDA 510(k) clearance K052892 · decided 2005-11-30
Clearance details
- K-number
- K052892
- Device name
- SYNTHALON PC PLUS POWDER-FREE POLYCHLOROPRENE EXAMINATION GLOVES, MODELS 1372-11 TO 1272-55
- Applicant
- Barriermed Glove Co.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-14
- Decision date
- 2005-11-30
- Days to decision
- 47 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Lake Mary, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.