ULTIMAX— 510(k) K951473
Substantially EquivalentWembley Rubber Products (M) Sdn Bhd
FDA 510(k) clearance K951473 for ULTIMAX, Substantially Equivalent on 1995-07-17. 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
- Malaysia, MY
Recent devices under product code KGO
view all- K260558 — Latex Powder Free Surgical Gloves Tested for Use with Chemotherapy Drugs and Fentanyl Citrate +1 more
- K253060 — Sterile Latex Powder Free Surgical Gloves
- K250313 — Sterile Powder Free Synthetic Rubber Surgeons Gloves, Green Color, Tested For Use With Chemotherapy Drugs and Gastric Acid
- K240790 — Polyisoprene Surgical gloves
- K232079 — Natural Rubber Latex Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl (Green) +1 more
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.