Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant— 510(k) K222058
Substantially EquivalentWrp Asia Pacific Sdn. Bhd.
FDA 510(k) clearance K222058 for Polyisoprene Surgical Glove, Powder Free, Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant, Substantially Equivalent on 2022-10-22. 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
- Sepang, MY
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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
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- K210330 — Powder Free Black Nitrile Examination Gloves, Non-Sterile, Tested for Use with Chemotherapy Drugs and Fentanyl Resistant
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Data sourced from openFDA. This site is unofficial and independent of the FDA.