POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
FDA 510(k) clearance K102790 · decided 2010-11-29
Clearance details
- K-number
- K102790
- Device name
- POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG
- Applicant
- Perusahaan Getah Asas Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2010-09-27
- Decision date
- 2010-11-29
- Days to decision
- 63 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Klang, Selangor, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.