Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
FDA 510(k) clearance K162095 · decided 2016-11-02
Clearance details
- K-number
- K162095
- Device name
- Non-Sterile, Powder Free Nitrile Examination Gloves, Tested for use with Chemotherapy Drugs (Original Blue, Cobalt Blue)
- Applicant
- Yty Industry (Manjung) Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2016-07-28
- Decision date
- 2016-11-02
- Days to decision
- 97 days
- Clearance type
- Traditional
- Product code
- LZA
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Sitiawan, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.