MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES— 510(k) K063757
Substantially EquivalentShanghai Motex Healthcare Co., Ltd.
FDA 510(k) clearance K063757 for MOTEX POWDER-FREE SURGICAL GLOVES AND LIGHTLY POWDERED SURGICAL GLOVES, Substantially Equivalent on 2007-07-27. Applicant: Shanghai Motex Healthcare Co., Ltd.. Device class: 1.
Clearance details
- Applicant
- Shanghai Motex Healthcare Co., Ltd.
- 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
- Hsin Chu City, TW
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 Shanghai Motex Healthcare Co., Ltd.
view all- K123126 — MOTEX POLYISOPRENE POWDER-FREE SURGICAL GLOVES MODEL # 6412(6432) AND # 6512(6532)
- K132802 — MOTEX POWDERED NITRILE SURGICAL GLOVES
- K122557 — MOTEX POWDER-FREE NITRILE SURGICAL GLOVES
- K041276 — POWDER-FREE NITRILE EXAMINATION GLOVES
- K030207 — NITRILE POWDER-FREE EXAMINATION GLOVES, PROBLUE, #7235 7 #7735
Data sourced from openFDA. This site is unofficial and independent of the FDA.