Nitrile Glove Powder Free White
FDA 510(k) clearance K183068 · decided 2018-12-21
Clearance details
- K-number
- K183068
- Device name
- Nitrile Glove Powder Free White
- Applicant
- Haining Medical Products Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2018-11-05
- Decision date
- 2018-12-21
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Tangshan, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.