Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102) +3 more— 510(k) K223903
Substantially EquivalentSemperit Investments Asia Pte , Ltd.
FDA 510(k) clearance K223903 for Non-Sterile, Single use, Powder-free examination glove, Blue, tested for use with Chemotherapy drugs and Fentanyl SMALL SIZE (NGPF102) +3 more, Substantially Equivalent on 2023-01-27. Applicant: Semperit Investments Asia Pte , Ltd.. Device class: 1.
Clearance details
- Device name as filed
- 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.
- Product code
- Code LZA
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Singapore Central, SG
Recent devices under product code LZA
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- K260794 — NON-STERILE POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, WITH LICORICE ROOT EXTRACT AND UREA, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, FENTANYL CITRATE, XYLAZINE HCl, AND GASTRIC ACID. OCEAN COLOR
- K262014 — PUREZERO* MARIN* Nitrile Powder-Free Exam Gloves; PUREZERO* MARIN-XTRA* Nitrile Powder-Free Exam Gloves
More clearances from Semperit Investments Asia Pte , Ltd.
view all- K183441 — Powder-free Nitrile Patient Examination Glove, Green Colored, Non-sterile, Low Dermatitis Potential, and Tested for Use with Chemotherapy Drugs
- K171378 — Non-Sterile, Single use, Powder-free examination glove tested for use with Chemotherapy drugs
- K160781 — Sempermed Syntegra IR, Sterile Powder Free Synthetic Rubber Surgeons Gloves
Adverse events under product code LZA
product code LZA- Other
- 1
- Total
- 1
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.