POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
FDA 510(k) clearance K110970 · decided 2011-07-21
Clearance details
- K-number
- K110970
- Device name
- POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED)
- Applicant
- Ppp Medical and Safety Products Company Limited
- Decision
- Substantially Equivalent
- Date received
- 2011-04-06
- Decision date
- 2011-07-21
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- LYZ
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rd. Hai Di Beijing, CN
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Ppp Medical and Safety Products Company Limited
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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.