POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS)— 510(k) K022442
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K022442 for POWDER FREE GREEN LATEX SURGICAL GLOVES, STERILE WITH ALOE VERA AND PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM LESS), Substantially Equivalent on 2002-09-05. Applicant: Wrp Asia Pacific Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wrp Asia Pacific 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
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 Wrp Asia Pacific Sdn. Bhd.
view all- K232538 — DUAL COLOR NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS AND FENTANYL
- K230578 — Polyisoprene Surgical Glove (Unified Double Layer), Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl
- K222058 — Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
- K211601 — Powder Free Latex Examination Glove, Non-Sterile
- K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
Data sourced from openFDA. This site is unofficial and independent of the FDA.