HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT— 510(k) K013324
Substantially EquivalentTillotson Healthcare Corp.
FDA 510(k) clearance K013324 for HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT, Substantially Equivalent on 2001-11-29. Applicant: Tillotson Healthcare Corp.. Device class: 1.
Clearance details
- Applicant
- Tillotson Healthcare Corp.
- 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
- Bedford, NH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.