Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
FDA 510(k) clearance K163017 · decided 2017-03-22
Clearance details
- K-number
- K163017
- Device name
- Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs
- Applicant
- Gmp Medicare Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2016-10-28
- Decision date
- 2017-03-22
- Days to decision
- 145 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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Recalls involving this device
No recalls on record reference this clearance.