POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM— 510(k) K113233
Substantially EquivalentShen Wei (Usa), Inc.
FDA 510(k) clearance K113233 for POWDERED LATEX SURGICAL GLOVES STERILE, STERILE WITH PROTEIN CONTENT LABELING CLAIM, Substantially Equivalent on 2012-03-29. Applicant: Shen Wei (Usa), Inc.. Device class: 1.
Clearance details
- Applicant
- Shen Wei (Usa), Inc.
- Product code
- Code KGO
- Device class
- Class 1
- Regulation
- 21 CFR 878.4460
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Union City, CA, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.