COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
FDA 510(k) clearance K002064 · decided 2000-11-28
Clearance details
- K-number
- K002064
- Device name
- COMFIT CHEMO PLUS POWDER FREE BLUE NITRILE EXAMINATION GLOVES, NON STERILE (TESTED FOR USE WITH CHEMOTHERAPY DRUG) LABEL
- Applicant
- Wrp Asia Pacific Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-07
- Decision date
- 2000-11-28
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Salak Tinggi, Sepang Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.