POWDERED VINYL EXAMINATION GLOVES
FDA 510(k) clearance K122176 · decided 2014-04-11
Clearance details
- K-number
- K122176
- Device name
- POWDERED VINYL EXAMINATION GLOVES
- Applicant
- Shu Tong Xinghua Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-07-23
- Decision date
- 2014-04-11
- Days to decision
- 627 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Xinghua, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Shu Tong Xinghua Co.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.