Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
FDA 510(k) clearance K202003 · decided 2021-02-24
Clearance details
- K-number
- K202003
- Device name
- Nitrile Powder Free Examination Glove, Blue Tested for Use with 32 Chemotherapy Drugs and Fentanyl Permeation Resistance Claim
- Applicant
- Gmp Medicare Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2020-07-20
- Decision date
- 2021-02-24
- Days to decision
- 219 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.