MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
FDA 510(k) clearance K123126 · decided 2014-06-04
Clearance details
- K-number
- K123126
- Device name
- MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
- Applicant
- Shanghai Motex Healthcare Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2012-10-04
- Decision date
- 2014-06-04
- Days to decision
- 608 days
- Clearance type
- Traditional
- Product code
- KGO
- Device class
- 1
- Regulation number
- 878.4460
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Shanghai, CN
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.