NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
FDA 510(k) clearance K984356 · decided 1999-01-08
Clearance details
- K-number
- K984356
- Device name
- NITRILE PATIENT EXAMINATION GLOVE, BLUE OR GREEN COLORED (PREPOWDERED USP)
- Applicant
- Perusahaan Getah Asas Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 1998-12-07
- Decision date
- 1999-01-08
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Selangor, Darul Ehsan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.