Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
FDA 510(k) clearance K223903 · decided 2023-01-27
Clearance details
- K-number
- K223903
- Device name
- Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102); MEDIUM SIZE (NGPF103); LARGE SIZE (NGPF104); X-LARGE SIZE (NGPF105)
- Applicant
- Semperit Investments Asia Pte , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-12-28
- Decision date
- 2023-01-27
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Singapore Central, SG
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.