Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
FDA 510(k) clearance K200019 · decided 2020-04-06
Clearance details
- K-number
- K200019
- Device name
- Nitrile Powder Free Examination Gloved Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Blue), Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs and Fentanyl, Citrate (Black)
- Applicant
- Hartalega NGC Sdn. Bhd.
- Decision
- Substantially Equivalent
- Date received
- 2020-01-03
- Decision date
- 2020-04-06
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sepang, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Halyard Purezero Ultraviolet Nitrile Exam Gloves Reference Numbers: 48771 (XS), 48772 (Sm. recall (Z-2230-2026) | O&M HALYARD INC | 2026-05-22 |