LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
FDA 510(k) clearance K142270 · decided 2014-11-25
Clearance details
- K-number
- K142270
- Device name
- LATEX POWDERED EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM OF 200 MICROGRAM OR LESS PER GRAM OF GLOVE
- Applicant
- Hartalega Sdb. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2014-08-15
- Decision date
- 2014-11-25
- Days to decision
- 102 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bandar Sri Damansara, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.