BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
FDA 510(k) clearance K031768 · decided 2003-08-01
Clearance details
- K-number
- K031768
- Device name
- BARRIER-PRO CO-POLYMER PATIENT EXAMINATION GLOVE, POWDERED, WHITE (NON-COLORED) OR GREEN COLORED
- Applicant
- Perusahaan Getah Asas Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2003-06-09
- Decision date
- 2003-08-01
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Gambrills, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.