Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
FDA 510(k) clearance K230578 · decided 2023-08-31
Clearance details
- K-number
- K230578
- Device name
- Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- Applicant
- Wrp Asia Pacific Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-01
- Decision date
- 2023-08-31
- Days to decision
- 183 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
- Sepang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.