Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs— 510(k) K163017
Substantially EquivalentGmp Medicare Sdn. Bhd.
FDA 510(k) clearance K163017 for Nitrile Blue Powder Free Examination Gloves with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs, Substantially Equivalent on 2017-03-22. Applicant: Gmp Medicare Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Gmp Medicare Sdn. Bhd.
- Product code
- Code LZC
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Klang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.