Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
FDA 510(k) clearance K182382 · decided 2019-08-29
Clearance details
- K-number
- K182382
- Device name
- Nitrile Examination Powder Free Glove, Aloe Vera, Blue, Nitrile Examination Powder Free Glove, Aloe Vera, Pink
- Applicant
- Gmp Medicare Sdn Bhd (F25)
- Decision
- Substantially Equivalent
- Date received
- 2018-08-31
- Decision date
- 2019-08-29
- Days to decision
- 363 days
- Clearance type
- Traditional
- Product code
- LZC
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Klang, MY
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.