Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim— 510(k) K172420
Substantially EquivalentWear Safe (Malaysia) Sdn. Bhd.
FDA 510(k) clearance K172420 for Sterile Powder Free Nitrile Surgical Glove, White Colored. Tested for Use with Chemotherapy Drugs, with Non-Pyrogenic Labeling Claim, Substantially Equivalent on 2017-09-29. Applicant: Wear Safe (Malaysia) Sdn. Bhd.. Device class: 1.
Clearance details
- Applicant
- Wear Safe (Malaysia) 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
- Klang, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.