Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
FDA 510(k) clearance K181857 · decided 2018-11-20
Clearance details
- K-number
- K181857
- Device name
- Powder Free Nitrile Patient Examination Glove, Blue Colored, Non-Sterile, Low Dermatitis Potential. Tested for Use with Chemotherapy Drugs and Fentanyl Citrate
- Applicant
- Kossan International Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2018-07-11
- Decision date
- 2018-11-20
- Days to decision
- 132 days
- Clearance type
- Traditional
- Product code
- LZA
- 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.