Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
FDA 510(k) clearance K221983 · decided 2023-04-27
Clearance details
- K-number
- K221983
- Device name
- Biodegradable Powder Free Nitrile Examination Glove, Blue Color, Biodegradable Powder Free Nitrile Examination Glove, Blue Violet Color, Biodegradable Powder Free Nitrile Examination Glove, Green Color
- Applicant
- Guangdong Kingfa Sci. & Tech.Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2022-07-06
- Decision date
- 2023-04-27
- Days to decision
- 295 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Qingyuan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.