Nitrile Examination Gloves
FDA 510(k) clearance K213739 · decided 2022-06-22
Clearance details
- K-number
- K213739
- Device name
- Nitrile Examination Gloves
- Applicant
- Hangzhou Runheng Medical Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2021-11-29
- Decision date
- 2022-06-22
- Days to decision
- 205 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.