Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim— 510(k) K183149
Substantially EquivalentCentral Medicare Sdn Bhd
FDA 510(k) clearance K183149 for Blue Non-Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Low Dermatitis and Fentanyl Permeation Resistance Claim, Substantially Equivalent on 2019-07-04. Applicant: Central Medicare Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Central 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
- Teluk Intan, MY
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More clearances from Central Medicare Sdn Bhd
view all- K230681 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl
- K223752 — Black Non Sterile Powder Free Nitrile Examination Gloves, Tested for Use with Chemotherapy Drugs, with Chloroquine, Cyclosporin A, Retrovir, Gastric Acid and Fentanyl
- K230875 — Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs, with Gastric Acid and Fentanyl Permeation Resistance Claims
- K230564 — Green Non Sterile Powder Free Nitrile Examination Gloves
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Data sourced from openFDA. This site is unofficial and independent of the FDA.