POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
FDA 510(k) clearance K000867 · decided 2000-04-21
Clearance details
- K-number
- K000867
- Device name
- POWDER FREE LATEX EXAMINATION GLOVES, PEPPERMINT SCENTED (CONTAINS 50 MCGM OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN GR
- Applicant
- Sgmp Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2000-03-17
- Decision date
- 2000-04-21
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Songkhla, TH
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.