COMFIT/BEADED SURGEON'S GLOVE— 510(k) K951662
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K951662 for COMFIT/BEADED SURGEON'S GLOVE, Substantially Equivalent on 1995-05-17. Applicant: Wembley Rubber Products (M) Sdn Bhd. Device class: 1.
Clearance details
- Applicant
- Wembley Rubber Products (M) Sdn Bhd
- 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
- Salak Tinggi, Sepang Selangor, MY
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More clearances from Wembley Rubber Products (M) Sdn Bhd
view all- K982600 — PROFEEL SYNTHETIC COPOLYMER SURGICAL GLOVES (POWDERED)
- K972616 — ONCOLOGY PLUS POWDER FREE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972615 — CHEMO PLUS POWDER FREE BLUE LATEX EXAMINATION GLOVES (PROTEIN CONTENT LABELING)
- K972621 — PROFEEL POWDER FREE SURGICAL GLOVES (PROTEIN CONTENT LABELING)
- K953213 — COMFIT (POWDER FREE EXAMINATION GLOVES (HYPOALLERGENIC, LOW PROTEIN, BEADED)
Data sourced from openFDA. This site is unofficial and independent of the FDA.