X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS)— 510(k) K010961
Substantially EquivalentAnsell Healthcare Products, Inc.
FDA 510(k) clearance K010961 for X-TENDA CUFF POWDER FREE NON-STERILE LATEX EXAMINATION GLOVE WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS), Substantially Equivalent on 2001-05-31. Applicant: Ansell Healthcare Products, Inc.. Device class: 1.
Clearance details
- Applicant
- Ansell Healthcare Products, Inc.
- Product code
- Code LYY
- Device class
- Class 1
- Regulation
- 21 CFR 880.6250
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Massillon, OH, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.