Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
FDA 510(k) clearance K181047 · decided 2019-01-09
Clearance details
- K-number
- K181047
- Device name
- Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested for Use with Chemotherapy Drugs
- Applicant
- Smart Glove Corporation Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2018-04-19
- Decision date
- 2019-01-09
- Days to decision
- 265 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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.