Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
FDA 510(k) clearance K241970 · decided 2024-08-02
Clearance details
- K-number
- K241970
- Device name
- Powder Free Nitrile Examination Gloves (Blue), Tested for Use with Chemotherapy Drugs and Fentanyl Citrate (XS,S,M,L,XL,XXL)
- Applicant
- Kanglongda Vietnam Protection Technology Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2024-07-05
- Decision date
- 2024-08-02
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Thua Thien Hue, VN
- 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.