Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs +1 more— 510(k) K222993
Substantially EquivalentSentienx Sdn Bhd
FDA 510(k) clearance K222993 for Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs +1 more, Substantially Equivalent on 2023-08-18. Applicant: Sentienx Sdn Bhd. Device class: 1.
Clearance details
- Device name as filed
- Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, Green Tested For Use with 13 Chemotherapy Drugs; Flexylon Surgical Powder Free Gloves with Low Dermatitis Potential Claim, White Tested For Use with 32 Chemotherapy Drugs
- Applicant
- Sentienx 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
- Kulim, MY
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Data sourced from openFDA. This site is unofficial and independent of the FDA.