Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
FDA 510(k) clearance K161006 · decided 2016-08-04
Clearance details
- K-number
- K161006
- Device name
- Latex Powder Free Polymer Coated Examination Glove with Protein Labeling Claim of 50 Microgram or Less Per Gram of Glove
- Applicant
- Hartalega Sdn Bhd
- Decision
- Substantially Equivalent
- Date received
- 2016-04-11
- Decision date
- 2016-08-04
- Days to decision
- 115 days
- Clearance type
- Traditional
- Product code
- LYY
- Device class
- 1
- Regulation number
- 880.6250
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bandar Sri Damansara, MY
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.