DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
FDA 510(k) clearance K992128 · decided 1999-09-14
Clearance details
- K-number
- K992128
- Device name
- DASH SILICONIZED POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS
- Applicant
- Dash Medical Gloves Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 1999-06-23
- Decision date
- 1999-09-14
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Franklin, WI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.