510(k) K063810
- Device
- YULEX LATEX POWDER-FREE EXAM GLOVES
- Applicant
- YULEX CORPORATION
- 510(k) number
- K063810
- Product code
- OIG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-04-18
- Date received
- 2006-12-22
- Regulation
- 880.6250
- Classification name
- Powder-free Guayle Rubber Examination Glove
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- KATRINA CORNISH
- Address
- 37860 W Smith-Enke Rd. Maricopa AZ US 85239 85239
Source Documents#
Legacy Summary#
summary
FDA Review#
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