Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
FDA 510(k) clearance K182089 · decided 2019-07-30
Clearance details
- K-number
- K182089
- Device name
- Powder Free Blue Nitrile Examination Gloves - Tested for Use with Chemotherapy Drugs
- Applicant
- Platinum Glove Industries Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2018-08-02
- Decision date
- 2019-07-30
- Days to decision
- 362 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Selangor Darul Ehsan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.